Results-focused accounting leader with 9 years experience driving the seamless operation and performance of the accounts receivable and accounts payable functions for professional services organizations. Detail-oriented A/R and A/P analyst adept at identify and effectively resolve variances, discrepancies, and other issues. Self-motivated with an exceptional record while maintaining the highest standards for customer service. Fundamental knowledge of accounting functions (billing and receivables), quick learner, ability to multi-task, meet deadlines, work independently and/or as team player, excellent verbal/written communication skills & strong organizational skills. 5+years of experience in the field of Quality control & Assurance in Pharmaceuticals Microbiology for Sterile & Non-Sterile Testing. Worked in cGMP regulated environment with cGLP documentation skills. Able to work independently and in Team work in highly regulated environment. FDA and EU regulations knowledge of Environment monitoring of clean Rooms and Purified water systems. Clean Room Training evaluation and certification of aseptic techniques for employees to work in ISO 5 and 7. Working Knowledge of 21 CFR 210 and 211and USP related to microbial testing and 21CFR 820 quality system regulations. Change controls, CAPA, Investigations, Planned and unplanned deviations. ICH Q6, ICH Q7, ICH Q8, ICH Q9 requirements and Quality system review. Knowledge on Investigations relating to out of specifications relating to raw materials, excipients and finished products, environment monitoring biological indicators, high purity water systems. Extensive knowledge of SOP's and Batch Production Records, Change Control Skilled in record keeping in accordance with cGMP's, SOP's, Corrective and Preventative Actions (CAPA) Experienced in production and manufacturing within an FDA, OSHA regulated industry Strong experience working in a ethical and compliant manner to manufacture a drug product that is safe for human use. Seasoned, ambitious manager that leads and coordinates complex operations to maintain and improve product development/launches and manufacturing processes. Intuitive and skilled leader with business acumen and broad-based expertise, spanning quality assurance, process improvement initiatives, supply chain management, and product lifecycle management. Exemplary communication skills and excels in demanding, fast- paced environments. Core competencies. Extensive experience in Corporate Accounting including General Ledger maintenance, preparation of Financial Statements, Analysis, Comparative Schedules, P&L Reporting, Budgeting, Forecasting, and Payroll, Sales, Use and Excise Tax Filings. Team leader and player adept in assessing, planning, and problem solving, full charge bookkeeping, payroll and human resources. Utilized ADP WorkForceNow, Pay Expert, Pay Force, EV5, PCPW, Ez-labor, E-time Management, General Ledger Interface, I-Pay, Ceridian Latitude, MSAS, Oracle, PeopleSoft and Ultipro / Check Point-Back Office, Workday. Highly experienced in Elite Enterprise (3E), Aderant Expert Pro, and CMS.
Pick ordered items for packing. Do resolution for missing items where necessary. Pack and label items for dispatch to stores. Ensure general cleanliness of warehouse. Maintained clean and organized work areas. Adhered to all applicable regulations, policies and procedures for health, safety and environmental compliance. Read and interpreted standard operating procedures to complete work in an accurate and efficient manner. Set up and operated production equipment according to daily work orders and safety procedures. Worked with managers to implement the company's policies and goals. Kept production logs and maintained the inventory of job materials Inspected finished products for quality and adherence to customer specifications. Prepared and assembled materials and set up and operated production equipment in accordance with current manufacturing practices and standard operating procedures. Started up and shut down processing equipment. Processed weekly union payroll and $3M in bi-weekly payroll liabilities for staff for US locations across multiple states via ADP Workforce Now. Entered and audited payroll hours, inputted new employees, and approved employees for self- service tasks using a wide range of software programs. Edited deduction amounts and reconciled appropriate accounts while processing and responding to state and federal tax notices, achieving 98% rate of accuracy. Analyzed and audited payroll transaction requests and processed wage garnishments, levies, support orders, bonuses, commissions, and benefit adjustments for 1,100+ employees. Provided employees and management with comprehensive payroll support, ensuring all issues were resolved promptly and accurately. Created and distributed post-processing reports and standard ad hoc custom reports for finance and management departments, including 401K, FSA, HSA, and PTO. Developed analysis spreadsheets and payroll reports for auditing purposes and management operations. •Managed daily operations for weekly payrolls for seven company codes. Oversees the processing and reconciliation of 600 Multi-State employees through ADP WorkForceNow.
•Maintained and processed Garnishments, Levies, Student loans and other mandatory deductions.
•Maintained ADP WorkForceNow Master File, mapping, salaries, titles, earning and deductions codes. Evaluated internal controls and processes. Make recommendations to ensure best practices and maintains an efficient payroll environment ensuring compliance with the organization policies, state, and federal laws.
•Filing and reconciling quarterly tax reports, year end and tax regulations updates. Processed sign-on bonuses, expenses and uniform reimbursements, salary increases, promotions, transfers, terminations.
•Processed stop payments, EFT reversals, check reversals and issued manuals checks as needed.
•Preparing, auditing, transmitting, and receiving payroll files from ADP WorkForceNow.
•Updated timecards, missed punches for union hourly employees, adds exception time and time not reported for previous pay periods, updated futures PTOs request and time accruals for Exempt and Non-Exempt employees.
• Enrolled New Hires into time and attendance clock system and monitors time in WorkForceNow.
• Performed special projects and produced ADP WorkForceNow reports on a needed basis for accounting, senior management and HR Dept.
• Monitored and process leave of absences for STD/LTD, FMLA, work closely with internal customers and HR. Performed audits of ADP and other applications to insured proper updates, such as WageWorks transit, 401K, 401k Match, General ledger files for accounting purposes and resolved other payroll related issues.
• Provided customer service and security administration for end users, responded to payroll related inquiries in a timely fashion. Interfaced with recruitment, compensation & benefits in order to accurately maintained HRIS data base.
• Handled Employee Relations by serving as the first point of contact for employees. Directed associates seeking policy clarification and HR-related inquiries to management and/or an HR Business partners.
• Processed new hire and termination paperwork. Coordinated and conducted new hire orientation. Managed all recruitment efforts from initial prescreening, in person interviews, administered skill evaluations. Coordinated drug screening and physicals. Educated new hires on benefit, insurance policies and OSHA requirement policy. Maintained personnel files in compliance with records retention policy and applicable legal requirements. Acted as site liaison in troubleshooting associate issues relating to payroll, timekeeping and benefits.
• Coordinated various associate meetings, including scheduling, invitations, room arrangements, lunches, maintaining attendance records. Assisted associates and supervisors in the return-to-work administrative processes. Assisted with the translation of specific documents into other languages as well as translate for employee relation situations.
Utilized Aderant Expert time and billing software to enter client and billing data; generate pre-bills for attorney review and make any necessary changes prior to generating invoices. Identify and resolve any accounting discrepancies or errors.
● Prepare invoices to be submitted electronically by converting into LEDES format and submit electronically through various E-Billing websites. Maintain a high level of accuracy and productivity in fast paced environment.
● Communicate extensively with clients, attorneys, paralegals, and support staff to answer billing inquiries. Open/set up new accounts and implement account changes as well as performing conflict checks on potential new clients. Generate a wide variety of month-end reports including aging, disbursement, and billing summaries.
● Provide leadership, guidance, and training to new employees in all aspects of billing procedures. Interface with Collection Department to initiate and coordinate legal action on seriously delinquent accounts. Employ considerable interpersonal skills to project a positive and professional image of the firm.
● Act as a liaison between Billing and Technical Support Departments to coordinate computer repair functions. Run monthly pre-bills and distribute various reports to attorneys for bill processing.
● Produce final bills in Aderant (CMS) Billing System once reviewed by attorney. Prepare invoices including narrative edits, time transfers, time combination, credit application, and write offs, and apply retainer funds as directed by attorneys.
● Upload invoices electronically to various Legal Billing websites and troubleshoot errors on LEDES
files and websites to ensure invoice is submitted.
● Research, review and analyze unbilled time and aged work-in-progress (WIP)
● Efficiently provide partners with A/R information and inform accounting manager of necessary action. Responsible for accurately posting, totaling and controlling all cash and adjustments to the appropriate client accounts which include checks, ACHs and wires. Prepare and deposit checks to the bank daily by creating batches and scanning checks into remote deposit software. Prepare daily cash report and tracked budget for distribution to the Controller and Senior
● Research and resolve unidentified, unallocated and misapplied receipts. Respond to internal and external inquiries about specific payments and billing requests. Assist with completing the month end and year end process which requires the running, printing, summarizing of multiple reports and distributing to the Controller and Senior Administrators.
● Update accounting system's file maintenance in the areas of address changes and clients that split payments. Run, compile and distribute proformas to billing attorneys/secretaries and maintain accurate up- to-date status log of proformas and bills.
● Prepare invoices for attorneys using Aderant Expert Pro Accounting System, transfer of time and costs, review A/R, retainers, unapplied cash and process bills to A/R. Work closely with billing attorneys and secretaries to ensure timely processing of bills.
● Efficiently and accurately research aged WIP (work-in-progress) and resolve unapplied retainers, unapplied cash on accounts.
● Coordinate with cash receipt staff to ensure accurate applications of cash and write-offs.
● Perform independently in the Newark office with no supervision and communicate with other
billing analysts nationwide as required to meet all deadlines. Submit invoices by email or electronic invoices using E-Bill Hub, Tymetrix 360, Serengeti, Collaborati, CounselLink, Datacert (ShareDoc), Legal Precision, Bottomline Legal Exchange, and Eliot and assist E-Billing Team to resolve errors on LEDES files to ensure invoices are submitted.
● Review New Matter Intake Forms and Engagement Letters to ensure timekeepers, special rates and discounts are updated on system prior to billing
● Enter daily receipts of payments (including lockbox, wires, ACH, checks, and internal transfers) for all accounts including trust accounts, ensuring that wire fees and other agreed write-off arrangements are completed in a timely manner to ensure accurate maintenance of accounts receivables balances.
● Analyze major client ledger records to ensure proper allocations were made so that the firm A/R reports are accurate.
● Facilitate communication with firm clients, attorneys, secretaries, client account representatives, and accounting personnel to resolve application related issues on client accounts.
● Monitor un-allocated and unapplied receipts for timely resolution. Processes client refunds related to duplicate or erroneous payments.
● Maintained a functional knowledge of Aderant's billing module in order to communicate effectively with billing personnel regarding various options used to customize billing and receipt applications to meet client requirements.
● Maintain a working relationship with the firm's banking contact to locate missing checks or resolve other bank errors and address client inquiries concerning misdirected funds.
● Handle completion of time-sensitive audit requests. Maintains logs/listings of special client arrangements or AFA's including the firm's "watch list" of expected cash receipts.
● Create and distributes daily Cash Receipts Package Report to Management, to include reconciling all payment and trust batches to bank deposits and online statements.
● Identified and researched discrepancies/disputed items and recommends account adjustments to clear such items
from client accounts. Monitor client's unpaid balances.
● Communicate with assigned Attorneys to discuss and summarize collection tactics and strategies, establish priorities and push for desired results.
● Articulate in a calm and professional manner with the Firms internal and external clients when discussing payment due to the Firm.
● Carry out the directives of the Billing Attorneys, CFO and Controller, all whom have a role in the collection of the Firms.
● Accounts Receivables. Escalate situations involving internal/external clients as appropriate.
● Obtain and maintain client information and accurately notate this information in the Aderant
Financial System as well as ARCS Collection database.
● Prepare various AR reports from existing systems, (Aderant, ARCS) as necessary.
● Research and resolves unapplied payments and unapplied credits for Cash Applications Specialist.
● Use Analytical skills to review A/R aging reports and identify areas in need of concentration.
● Manage Quality control, deadlines, timely reporting on billing status, and thoroughly analyze special billing arrangements.
● Support assigned billing attorneys in full cycle of account management, including account set up,
billing and collection arrangements and inventory management.
● Preparation of electronic bills thru e-billing Hub (Tymetrix 360, Serengeti, Bottom-line, Sharedoc, Legal Precision, Legal Solutions, Trial Net, DataCert, LawTrac, Allegient, Counsel Link, Collaborati).
● Reviewed and verify accuracy of billing and supporting documentation as required.
● Researched and respond to inquiries regarding billing issues and problems.
● Created new billing formats, schedules and various other billing analyses as required.
● Creates and printed final client billing, created and distributed monthly reports. Assisted with special projects as needed.
● Set up e-billed clients in Aderant Expert Pro/CMS software system and ensure all User Defined Fields and accounts are properly set up for tracking and upload.
● Audit electronically billed client accounts to ensure that they are properly set up and linked to the correct client third party submission site.
● Design and implement training program for third party client bill submission sites.
● Train Attorneys, Paralegals, e-billers and Legal Assistants on use of third-party electronic billing
sites. Audit invoices to ensure staff comply with client requirements for billing.
● Upload and maintain rates for billing attorneys at third party client bill review sites.
● Analyze aged Accounts Receivables for electronically billed clients for collection feasibility through coordination with the collection's coordinator.
● Audit electronically billed invoices and reconcile them to A/R figures and dates to ensure they are submitted in the appropriate period.
● Post daily wires and ACH payments received daily for domestic and international offices. Record Non-US payments received from third party service providers and record applicable VAT (Value Added Tax). • Record
Interest bearing escrow accounts and record applicable interest monthly.
● Perform monthly reconciliation of firm's American Express accounts; ensure all applicable charges have been issued purchase order numbers and are ready for payment.
● Audit and resolve payment discrepancies through independent research with firm provided
● Coordinate corrections of incorrect allocation of revenue received. Firm liaison for internal/external communications with clients via written communication.
● Organize and distribute draft bills, audit bill requests in accordance with established firm policies, ensure completeness and accuracy of all information submitted, identify and meet client billing requirements, process transfers and write-downs, obtain appropriate approvals, coordinate application of unapplied cash/escrow, identify and troubleshoot billing issues, and print bills.
● Research, analyze, and process all rate change requests for all U.S. offices.
● Provide guidance and respond to inquiries regarding billing, rates, AFAs, time entry, accounting system inquiry, firm accounting policies, and complex client billing situations.
● Develop and communicate procedures for alternative and fixed fee arrangements. • Create and improve client- related financial reports.
● Train Legal Administrative Assistants on billing functions and accounting system, and train new
Billing staff on all billing policies and procedures.
● Assist attorneys and assistants with managing clients with complex and demanding billing guidelines, including special reports, large multi-matter billing, split billing, and electronic billing.
● Monitor progress and timeliness of monthly billing statistics for all U.S. offices, and work with attorneys and management to obtain and process as much billable inventory as possible.
● Maintain spreadsheets for petty cash.
● Working directly with the Accounting Manager on implementing new process to improve procedures firmwide. ● Replenish and reconcile USPTO deposit account with over 5,000 monthly itemized charges, ensure proper charges to client matters, and resolve discrepancies.
● Guide Billing Specialists with daily workflow and projects, resolve complex billing issues, assist
with processing of complex bills.
● Recommend ideas for opportunities to improve billing processes and procedures. • Work with Collection Executives to resolve billing and collection problems.
● Provide back-up and assistance to Intellectual Property/Value Billing Specialist, Senior Accounts Payable Specialist, and Billing Manager.
● Performed all billing related tasks: transfers, write-downs, write-off, discounts, cancellations, rate sets and application of funds.
● Review all invoices for proper documentation, coding and approval prior to payment.
● Communication with staff and vendors to help investigate and resolve problems, solely responsible for coordinating the processing of invoice payments.
● Petty cash and expediting rush checks orders between 6 firm offices. Maintain vendor files for audit purposes; preparation and issuance of 1099 vendor forms. Processing wire payments. Reconciliation of monthly credit statements.
Assisting as needed with month-end/quarter -end close responsibilities.
Processed/manufactured pharmaceutical products in accordance with written processing orders. Prepared manufacturing areas and equipment for the productions of pharmaceutical products. Cleaned processing equipment and rooms in accordance with written.
• Standard Operating Procedures (SOPs) and established cGood Manufacturing Practices (cGMP). Ensured product quality meets the standards of Patheon, for the clients, and applicable regulatory agencies including, but not limited to the Health Products and Food Branch Inspectorate (HPFBI), United States Food & Drug Administration (FDA), and European Medicines Agency (EMEA). Followed the required Environmental Health and Safety (EH&S) and GMP requirements. Showed commitment by never calling out prior to a 12-hour shift and dedicated to weekend work when requested. Other Tasks include Review of Batch Record, Cleaning suction head, Upper die assembly, the Lower die assembly, Pressure plate and troubleshooting when needed. Cleaned the work area in a safe, hazard-free and neat condition as per SOP's using cleaning chemicals for sanitation and decontamination of the entire room before and after batch operation.
• Removed trash and other disposable protective apparel in cGMP area. Performed cleaning duties such as wiping, dusting, sweeping and mopping the floor. Assisted in the formulation and development of generic drug products in solid
dosage forms for immediate and modified release tablets, Soflet and Sofgel capsules.
• Under the supervision of the Supervisor of Formulation, executed new products from prototype formulation to scale-up to manufacturing full-scale batches and maintained all records related to the systems and operations. Agreed with the production staff in the implementation of a product transfer protocol from Formulation Department to Post Production In accordance with cGMP, OSHA and EPA regulations. Supported all local manufacturing operations in AHF-M Department. Performed Cryo suspension, centrifuge clarification, chemical additions, dilutions, sterile filtration, and other activities related to the manufacture/processing of AHF-M bulk. Operated general production equipment (such as centrifuge, autoclave, CIP/SIP, Mab/Q-Sepharose Column Chromatography, Completed relevant paperwork following
GDP/GMP guidelines. Participated on Continuous Improvement Teams. Received and distributed supplies into the production area as necessary. Prepared media buffer solutions. Assembled and operated filtration systems. Revised and reviewed pertinent documentation as appropriate. Performed troubleshooting of equipment referencing from the technical specs if available in-house or if not, obtained said specs from supplier or manufacturer. Built a good relationship with maintenance technicians while continuously learning skills to personally maintain department specific equipment for optimal functionality and troubleshooting. Trained new employees on procedure for which the MT3 is qualified as trainer. Run calibration procedures/ processes. Operate and maintain manufacturing equipment and maintain production readiness. Execute first particle.
• Self-managed assigned tasks to permit schedule flexibility and the processing of expedited testing and manufacturing assignments. Maintained accurate and well-organized records, worksheets and/or notebook. Highly proficient in the use of manufacturing equipment such as: oscilloscope equipment, Microscope inspection, soldering, and customized flow rate measurement. Successfully executed complex design validation testing for all critical new products before and after product launch. Operate and maintain manufacturing equipment and maintain production readiness. Execute particle manufacturing operations in cGMP facility at Pearl, including: Operate, Clean, and Maintain production equipment. Sample product and raw materials for release testing. Dispense raw materials for manufacture.
• Conduct preventative maintenance activities, where appropriate. Assist in maintaining equipment records pertaining to PM and calibration activities, and equipment warranties. Communicate production successes and issues to PDM engineers and management to improve manufacturing operations. Document production activities per SOPs and cGMPs. Maintain the inventory of consumables and supplies required for production.
• Support Materials Management operations: Receive materials used in cGMP production per SOP. Package and ship cGMP materials per SOP or protocol. Assist in maintaining warehouse operation per SOP. Maintain a safe working environment Observe and follow all safe operation practices. Maintain a clean and clutter-free production environment. Review and revise documentation to ensure documents adhere to company quality requirements and documentation is compliant with specified regulations. This includes Batch production records and logbooks. Operate feedstock preparation equipment. Operate spray dryer and perform collector change outs. Operate
jet milling equipment and perform collector change outs. Clean and maintain spray drying, feedstock preparation, and jet milling. Executed design validation testing Vapor device Assembly project; collect data for FDA submission and commercial release. And Working on new design working closely with Eng. Assume responsibility for data collection and analysis. Support engineering and manufacturing activities as required.
• Evaluated design improvements to currently released products to assess performance changes
Self-managed assigned tasks to permit schedule flexibility and the processing of expedited testing and manufacturing assignments. Performed complaint investigation appropriately escalating issues to management. Maintained accurate and well-organized records, worksheets and/or notebooks. Lead failure investigation.
• Organize the return of clinical trials materials from variety of source. Performed complaint and planned return trend analysis. Support engineering and manufacturing activities as required. Conducted PDS andT-326 field returns investigations such that design failure modes are identified and Good Documentation Practices are maintained; processes of field returns investigations ahead of projected schedule and restored compliance to internal thirty- day
investigation closure policy. Highly proficient in the use of manufacturing equipment such as: Rofin Sinar laser marking equipment, Microscope inspection, Spraytech VMD (Volume Median Diameter) metrology, soldering, and customized
flow rate measurement. Coordinate and supervise the daily activities of individual contributors, set priorities for the team to ensure task completion and meeting daily deadlines; coordinates work activities with other supervisors. Identifies and resolves standard day to day quality, technical, and operational problems within unit.
• Utilize sound judgement and decision making to ensure quality product is reliably produced while managing cost. Responsible for performance metrics (Schedule Adherence, Release on Time, Customer service performance, Product
Lead Time, etc.).
• Accountable for developing a Production System and continuous improvement culture while achieving targets and business results. Identify, prioritize and champion improvement initiatives to improve process efficiency, cycle time, and yield, reduce process variability.
• Accountable for meeting business acumen and understanding the business impact to finances.
• People Management - Responsible for creating and sustaining a highly engaged workforce through utilization of Core leadership Behaviors and Inclusion.
• Provide coaching on professional development and career paths. Provide timely feedback and performance evaluations for direct reports after obtaining the relevant input and evaluation. Direct, coordinate; provide guidance and counseling to group leaders to assure optimum quality and quantity of finished products.
• Managed over 145-employees in the Blending, Compounding, Ingredients Weighing, Premixes, Fluid Bed Agglomeration, Packaging and Sanitation Department at three Locations. Wrote and published Standard Operating Procedures and Policies pertaining to cGMP, OSHA, Food and Pharmaceutical Manufacturer Industries. Assured compliance to all procedures and policies concerning all areas of quality, regulatory, safety, and human resources. Assured that production schedules were formulated to maximize plant advantage. Responsible for the accuracy of the documentation required for production. Managed 8 industrial ribbon blenders each with a blending capacity between 4,400 and 6,000 pounds. Blended and shipped over $5,000.000 of finished dietary, food nutritional and supplement products weekly. Established and trained-up a 3rd shift. Inter-action with the warehouse in setting up systems for "pulling" and "staging" Work Orders to improve the efficiency and effectiveness of the blending and packaging department. Make work assignments to meet production schedules as dictated by production planning. Complete accurate and timely production reports and inventory transactions. Assured timely and relevant communications to and from all levels. Directed daily and monthly shift communication meetings. Interact with all departments to maintain Quality, Productivity, Safety, and Good Housekeeping. Monitor daily performance to ensure employees were working safely and problems identified and resolved. Conducted annual SOP's, GMP and Safety training for Blending and Packaging departments. Reviews and initiates all personnel organizational changes for respective shifts. Coached developed and mentors in areas of responsibilities. Provided supervision and education of newer team members. Strong ability to trouble shoot equipment problems avoided costly manufacturing errors. Conducted sampling operations and performed in process analytical analysis (pH, temperature, conductivity). Preparation set up and transfer of Buffer and Process solutions. Operation of CIP systems (Sanimatic, Dober). Operation of centrifuges and filter presses. Preparation of buffers and alcohol solutions. Managed all manufacturing activates at the Sterile Power facility including Filling, Sterilization, Inspection, and Packaging. Successfully set up a work force that handled filling one day and inspected and packaged the next. Increased production levels from 1 million units to 5 million units in three years. Increased filling yields from 91.5% to 96% over the three years. As Management Team member, contributed to successful FDA inspections for both GMP and pre-approvals. Managed all scheduling, inventory control, purchasing, warehousing, label room and accounting at the Pennsylvania facility. Implemented quarterly Quality Control Program with key suppliers to resolve issues with raw materials. Developed an excessive/obsolete Raw Material Tracing System, which reduced inventory levels by 20%. Led the implementation of the site's computerized shop floor system, which provided real time data and inventory tracking system. Contributed to the successful completion of a sixteen-week FDA plant inspection that achieved removal of the corporation from the FDA's AIP list. Achieved and maintained 100% customer service levels (no stock outs) of 86 product codes for three consecutive years, while simultaneously reducing finished goods inventory. Assisting manufacturing with building of process assembly records, weight-out of raw materials for testing, biohazard waste management, and manufacturing suite disinfection. Oversaw all plant operations on all products manufactured at facility. Set up all production operations from filling, labeling, quality inspection, pouching and packaging. Oversee all documentation for each product insure all documentation is completed correctly at each step of production and sign off on each of these steps before starting next step of production. Complete all daily production
reports, inventory, metrics and inventory transfers. Submit inventory amount from each lot produced into inventory system (JDE) for billing at end of shift. Oversaw all production changeovers. Oversaw all machine changeovers including setting up all program changes for specific products. Conducted all document training for all changes made for SOP documents for plant Implemented 5S program for plant operations. Implemented cross training program plant wide for all operators. Review all documentation met all FDA and company guidelines. Complete all operator reviews and training programs. Oversee all nonconformance issues that arise during production and adjust according to company and FDA guidelines. Supervise the 3rd shift Mixing, Coating, and Slitting Operations of up to 8 Operators. Operate 2 coating/ laminating lines.
●Manufacture Coating trials & specialty products/ tapes/ films/ foams/ & substrates.
●Mixing & custom blending of adhesives & solutions. ●Supervise/ Manage the operations of three coating/ laminating
●Assure that operations/ production/ testing are conducted in compliance with cGMPs, Sops, Quality Assurance and EPA, OSHA, DEA, FDA and other Regulatory requirements.
Pharmaceutical Coater/ Mass Preparation Operator II:
●Manufacture Medical and Transdermal pressure sensitive products utilizing coating/ laminating production lines according to cGMP standards. Mix/ Compound various adhesive/ chemical & aqueous/ oral compounds, coatings, and solutions. Perform appropriate tests and procedures on coated/ laminated products to ensure product quality. Manage the operations of three departments (Mixing/ Compounding, Coating, & Slitting).
●Supervised up to 40 employees of a 24 hour/ 7-day week operation.
●Perform Lean manufacturing, baseline and Kaizen Improvements with Six Sigma fundamentals.
●Controlled Substance (Class II & III Narcotics) Vault Monitor.
●Coordinate production between Production Planning, Mixing (Compounding) / Slitting/ Maintenance and Coating
●Troubleshoot product quality and machine and coating/ lamination issues with slitting and mixing (Compounding)
departments and with customers and vendors.
●Daily, monthly, yearly production/ efficiency reports.
●Accommodate present and future customers. Conduct Monthly Safety inspections.
●Conduct employee GMP/ SOP/ Safety training. Departmental inventory.
●Department purchasing agent and capital investments.
●Conduct personnel reviews/ performance evaluations and counseling reports and attendance reports.
●Write/ Review batch records, incident investigations, deviations, CAPA's and SOPs. Audit Department SOPs. ●Conduct Monthly Safety audits for department. Production & Process Cost Control and Improvements. Safety Committee & First Aid Team.
●SAP data entry of labor and production reports daily for up to 3 departments. Managed day-to-day operations of Blending, Compression, and Packaging Departments (team of 30). Audited existing processes; identified cost saving
steps. Implemented quality improvements including root-cause analysis and corrective actions. Gained SAP experience in compiling "Process Orders". Performed Kronos transactions for all hourly employees. Completed "Notice of Events" documentation.
●Was responsible for publishing corrective actions and preventative actions, conducting all interviews for potential
candidates, writing all of the worksite accident reports, and contacting the insurance carrier. Selected as a Member of First Aid Team. Updated and wrote Standard Operating Procedures (SOP's). Certified in all aspects of cGMP
regulations. Conducted comprehensive audits for bottle/polyester vendors.
● Utilize SAP software to track production orders and to correct "Cogi Errors". Responsible for true-up of orders and close-out of completed jobs. Provide leadership in reviewing batch records on a daily basis. Oversee daily operations in
Packaging Department (team of 19+ associates). Conduct cGmp training.Performed Kronos transactions. Make recommendations on inventory WIP and corrections needed. Provide feedback to increase production and efficiency
output. Perform detailed audits weekly on inventory to ensure SAP is correct. Conduct and complete weekly meetings with manager and supervisor to review production challenges and opportunities for improvement in production lines while leading and completing numerous projects.
• Performed safety audits weekly that resulted in breaking the longstanding company record for no OSHA recordable accidents. Named Employee of the Month twice in one year for outstanding achievements. Performs functions, common to all operations include Receiving, and Unpack aging (direct and indirect materials), Material Transfers, SAP Functions for Inventory Control, and Finished Product Transfers: Receipt of raw materials and consumables in SAP Provide material tracking and warehouse monitoring Disposition labeling and segregation of inventoried materials Maintain GMP warehouse through inventory cycle and yearly mass inventory counts and monitoring stock levels Store and locate complete inventory records of all materials purchased through ERP systems Provide SAP support to operations group with stock transfers Preparation of release packets of raw materials and consumables Assist QA in retrieving necessary documentation to have raw materials released and clear for manufacturing use Act as department liaison to Quality, Technical Services, and Operations Proper disposal of raw materials Packaging and Shipping Drug Substances, APIs, and Chemical Intermediates Knowledge of applicable cGMP requirements, procedures, methods and protocols for performance of assigned duties and responsibilities Proficient in Use of Electronic Systems: SAP, SRM. Translated business needs and priorities into actionable logistics strategies. Manufactured Provenge (Sipuleucel-T), an autologous cellular immunotherapy for advanced prostate cancer.
• Aseptic GMP manufacturing of clinical and commercial human blood therapeutics in a clean-room environment with biological safety cabinets, clean rooms classified as class ISO 5 or class 100. Maintained standard operating procedures (SOPs), batch records, and other applicable documentation to comply with regulatory requirements and current good manufacturing practices (cGMP). Actively monitored, coordinated, and executed timely completion of process documentation. Monitored and tested viable and nonviable airborne EM samples using SAS and Met One. Responsible for sterilization, assembling and processing of supplies and equipment used in aseptic Downstream Manufacturing.
• Monitoring and documenting process of Harvest, Inactivation, Filtration and Ultrafiltration.
Responsible for running, monitoring and documenting the process of CIP/Skid system, Tangentail Filteration Flow (TFF), UF/DF Skid, Filter Integrity Testing, Sonicater, parts washer.
Collecting samples at regular intervals during the processing stage and documenting all required data in Batch Production Record and LIMS Labware and also to track the status of the samples. Troubleshooting of CIP/Skid system, Sonicator, Parts Washer and Filter Integrity Testing when needed. Assisted Validation team in conducting validation testing for process and cleaning improvements. Perform cleaning cycle development Trial and qualifications for a variety of equipment including: Process Vessels, bioreactors. Perform cleaning validation testing including visual inspection, and the collection of rinse water samples, swab samples, and/or extraction samples. Write and execute cycle development protocols including development of final reports. Perform Out-of-Specification (OOS) Investigation, CAPA and writing OOS reports.
• Review, revise and maintain validation SOP's for conducting all validation works. Perform batch record review, including verifying calibration and in-process data. Perform spray coverage testing, cleaning verification swabbing. vaccine). • Performed all Viral vaccine manufacturing work (roller bottles) duties via automated systems, bioreactors, fermenters and Delta V in
compliance with SOPs and GMPs using aseptic/ sterile technique .
• Testing viable, non-viable (endotoxins), media preparation, WFI, personnel monitoring (RODAC), particulate counter (LASAIR, SMF, MET-ONE), Cell counts (haemocytometer, Vi-cells), autoclaves/ HEPA filters. Executing routine EM schedule (STR database/ LIMS), decontamination, and proper gowning techniques. Implement / execute corrective actions using CAPA systems. Worked on
investigation reports to determine the root causes for deviations.
Multi-Lingual in English, Hindi, Gujarati, Punjabi, French, and Spanish
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