LiveCareer-Resume

quality assurance associate resume example with 17+ years of experience

JC
Jessica Claire
Montgomery Street, San Francisco, CA 94105 (555) 432-1000, resumesample@example.com
Professional Summary

Sixteen’ experience in a high volume-manufacturing environment. Extremely motivated, driven, and customer oriented Manufacturing Processing Leader with more than 15 years’ experience and an established track record of achievements in pharmaceutical and chemical manufacturing. Highly skilled, thorough, and effective in all phases of process and product development, quality, and manufacturing.
Extremely focused on identifying system deficiencies and achieving customer satisfaction along with presenting ideas on cost efficiency and reduction. Focused team player with strong verbal and interpersonal communications who thrives on challenging situations requiring an ability to learn new skills and train other team members. More than 8 years of experience following cGMP, GLP, GDP, FDA and ICH guidelines. Technical expertise in reviewing cleaning and process validation; experience of handling technology transfer, preparing annual product quality reports, conducting internal audits for cGMP compliance and vendor qualification activity for contract manufacturing. Reviewing and approving SOPs, protocols, technical documents and stability data and reports for cGMP compliance. Knowledge of industry specific application i.e. SAP and TrackWise; effective communicator with written and oral communication skill; able to troubleshoot, prioritize and solve problems in a timely manner and interact with individuals on all levels; experience of supervising a QA team and coordinating with the different functional group to perform day to day activities. Dynamic business leader with over 18 years of experience in Sales, Marketing, Category Management, Advanced Analytics and Shopper Insights in the consumer packaged goods and grocery industry.
I am trained in safely cleaning, setting up, and operating Pharmaceutical manufacturing equipment such as Glatts, pump skids, swecos, tanks, tri-blenders, blenders, comils, fitzmills, grals, Ohara drying ovens, Tablet Compression & Encapsulation, and moisture analyzers. Hands-on experience with a variety of manufacturing equipments such as fluid bed, tablet press, tablet pan coater and mixers. Hands on experience with core solid dosage form processing techniques such as mixing, granulation, drying, compression, and coating. Experience on process development activities, practice their control parameters and perform process scale up using a systemic general approach for various processes.
Comprehensive understanding of the functional role of excipients and their effect on the processing and performance of drug product. Experience on preparing semisolid formulations such as gels and ointments. Experienced on preparing solid and liquid dosage forms including solutions and dispersions such as emulsions, microemulsions, and liposomes.
Process/Production Support) with six years of experience in cell culture operations, bioreactor prep/sampling, and media prep. Able to execute daily activities with specific skills, including: good aseptic techniques, strong understanding of following cGMP guidelines, and knowledge of Microsoft Office Tools and PowerPoint. Recognized by peers for being collaborative, accountable, and dependable. Results-driven customer service and operations professional with experience in biotech, medical device, pharmaceutical, and health care industries.

Skills
  • CGMP Compliance
  • CGMP Compliance
  • Microsoft Office
  • Negotiations
  • Lean Manufacturing
  • Leadership
  • SAP
  • Oracle
  • JDE
  • NetSuite
  • Quality Assurance
  • Quality Control
  • Sampling
  • Validation Protocols
  • Batch Production Records
  • Production Line Audit
  • Yield Evaluation
  • Inspections
  • Packaging Specifications
  • Raw Material Inspection
  • ATP Hygiene Tests
  • Surface Swab Tests
  • Correction action planning
  • Materials inspection
  • Project Management
  • Adept at performing analysis
  • Discretion
  • Technical capacity
  • Sound quality management techniques
  • Materials inspections
  • Technical troubleshooting
  • Protocol development
  • Performance testing
  • Testing procedures
  • Equipment calibration
  • Operations monitoring
  • Corrective actions
  • Data interpretation
  • Sampling protocols
  • Excel
  • Word
  • PowerPoint
  • Outlook
  • Great Plains
  • MS Dynamics
Work History
11/2020 to Current Quality Assurance Associate Ani Pharmaceuticals | Indianapolis, IN,
  • Laboratory analysis by HPLC and Dissolution Instrumentation on stability samples. Maintain an accurate laboratory notebook which includes sample data for all tests performed. Perform daily calibrations and routine maintenance on laboratory instrumentation and equipment according to current SOPs.
  • Assisted in various other duties that contribute to the organization and function of the laboratory. Serve as a technical trainer for other associates. Maintain a high level of awareness for GMP. Responsible for performing chemical and physical analysis of solid and semisolid pharmaceutical products in accordance with company's specifications and Compendia requirements. Responsible for following Laboratory trigger and In-process board to support manufacturing rhythm wheels and business rules. Generate investigations of non-conformance product.
  • Performed internal audits to ensure GMP compliance. Integrated the 2020 Annual Product Review team to verify monthly product compliance with specifications. Performed Assay testing for Drug Substance and finished products. Conducted
  • And revised laboratory deviations/investigations. Performed and generated Change Request plan for SOP. Audited laboratory logbook and testing data.
  • Followed SOP's and approved methods under FDA regulations.
  • Participated in method transfer activities for SP-New Jersey.
  • Integrated the QC Laboratory set up for FDA audit and performed
  • Method transfer using GC and HPLC. Executed method transfer in an external company which developed methods for Torrent. Performed physical and chemical analysis of raw materials and bulks.
  • Provided QA support/approval for all cross-funtional departments. Reviewed/approve QMS records (i.e., Deviations, CAPAs, and Change Controls) (since company re-organization).
  • Review/approve executed batch records and perform finished product lot disposition for potential Clinical Trial Materials (since company re-organization). Review/approve Method Qualification/Validation protocols and reports, as well as Product Development Reports for R&D (since company re-organization).
  • Supported development and implementation of robust internal audit and external audit/vendor management programs.
  • Conducted vendor audits for CMOs, raw material manufacturers, and single-use component manufacturers affiliated with Torrent Pharma. Conducted routine internal audits for all GxP-related departments (GMP and GCP). Collaborated with Clinical Operations and Clinical Development departments to develop and implement an in-house Clinical QA program. Conducted 100% data verification for eleven (11) Clinical Study Reports (CSRs) and one (1) Regulatory Briefing Document.
  • Ensure compliance though audits, training data and document reviews, and analysis. Collated Manufacturing and Packaging Batch Records Issuance processes from VEEVA Vault, TrackWise, updating Access, SAP and gLIMS databases that ensured timely manufacture. Issues, reviews and organized batch production records for machinability and demo runs for clients and products.
  • Complete Certificate of Conformance (COC), Certificate of Manufacture (COfM) and transcribe Certificate of Analysis (COA).
  • Complete Shipping documents to transfer bulk products to packaging Facility. Generate Deviation Reports using TrackWise and assist Quality Engineers with investigations. Initiated Hold Notifications / NCR (Non-Conformance Report) and collaborates with Quality Engineers to initiate Corrective and Preventative Actions (CAPA). Collate quality related data for trending and further analysis. Issue and reject raw materials, work in progress and finished products based on project record disposition.
  • Used SAP, TrackWise, Box and gLIMS to input and extract information. Generate Logbooks, Investigation Reports and Notice of Incident Reports. Provided quality assurance floor support for operations as a Quality Assurance Inspector.
  • Performed AQL attribute sampling inspection of finished products and tighten quality inspections, as necessary. Review quality procedures, batch records, in-process test results and AQL attribute inspectors. Coordinate with the launch of new product as a QA Product Release Associate.



03/2018 to 11/2020 Manufacturing Operator Ii-Vi Incorporated | Boston, MA,
  • Performed and documented daily manufacturing operations in a cGMP environment that involved operation of process equipment, execution of validation protocols, revising cGMP documents; detailed- oriented with strong documentation skills. Executed manufacturing processing steps and manufacturing support activities, monitored the process against the batch record, SLR and control system.
  • Experienced in basic biotechnology processing - major unit operations and microbial control concepts. Identified problems, analyzed situations, suggested solutions and made routine decisions based on experience. Clearly communicated process information and process issues with co-workers and supervisors in a timely manner. Interfaced with internal/external customers; demonstrated excellent communication and customer service skills.
  • Managed time with multiple projects/tasks. Team Player with excellent interpersonal and computer skills; Great ability to build relationships and demonstrate leadership in a High Volume Manufacturing facility. Operated equipment and oversaw manufacturing processes in the Dissolving/Filtration Dept. and LSM Cell Culture. Dispensed and tested samples for pH, viability, Total Cell Density, Viable Cell Density, conductivity, Glucose Concentration, osmoality, CNC testing, bioburden testing, and LAL. Performed double checks, select and off-test powders, calculated and weighed batch ingredients. Reviewed, revised, and maintained SOPs. Experienced in using the following MACHINES / TOOLS / MATERIALS: Coulter counter, cedex counter, hemoceptometor, microscope, bio-hazardous cabinet/hood. YSI analyzer, BGA analyzer, pH meters, conductivity meters, osmometer, pipettes, hand tools, pumps, hoses, process control instrumentation meter, spectrophotometer, turbidity meter, Fork truck, filter housings, chemicals, steam, hot/cold WFI, air pressure, carts, autoclaves, computer consoles and keyboards, SOP'S, MSDS, BPR'S, & MRM's.
  • Unloaded rail cars, truck tankers, totes and 55 gallon drums into various tank farms. Followed all GMP, SOP, ISO and MSOEs. Blended over 300 different type batches into various size containers. Took all lab samples, made all labels, recorded all chemicals used in batches and made corrections when needed. Performed chemical processing and batch mixing such as enzymatic treatment, alkali treatment, tendon prep, dispersion prep, and cross linking, to produce various collagen-based products. All processing was performed in compliance to GMP’s and SOP’s in a quality system with FDA compliance.
  • Consistently achieved 92% work order completion or exceeded daily output volumes required to meet necessary customer demand.
  • Change out chemicals to neutralize and sterilize parts needed to run a continuous process. Operating machinery such as Lancer and Getting machines that clean and Autoclaves that sterilize all equipment in the Core process. Routinely assemble cell culture kits to run in process and sterilized all equipment for the process according to SOPs. Operate in cleanroom environment on a daily bases wearing the proper gowning for GMP’s. Used machinery such as mix tanks and lyos to prepare dispersions and produce medical suturable items used in the medical field.
06/2004 to 11/2017 QA Analyst/Customer Business Analyst/Buyer Janssen Pharmaceuticals | City, STATE,
  • Extensive experience in pharmaceutical and diagnostics manufacturing. In depth knowledge of FDA and OSHA regulations with a track record of ensuring that work was performed in accordance with external regulatory authorities and all SOP's and QSRs. Saved company $18 million by building new production areas. A resourceful problem solver with and an expertise in SAP. Responsible for the Quality Assurance review of cleaning records, granulation, compression, and packaging batch records for Imodium (treatment for diarrhea) and Pepcid (treatment for heartburn). Determined the Product Disposition / Usage Decision (UD) for the batches to indicate whether or not they are approved for packaging and shipment. Utilized the SAP (Systems, Applications, and Products) computer program to record these dispositions of the commercial bathes.
  • Performed line clearances and retain inspections to ensure product quality during the manufacturing process. Responsible for coordinating the performance of the batch record review and the performance of the investigation so that they can be released for shipment in an efficient and timely manner. • Managed analysis of POS and shipment trends for J&J’s 4th largest OTC Drug customer ($145MM shipments)
    Competitive tracking and promotional analysis for the Zyrtec Launch, influenced Rite Aid’s PL pricing and development of new Zyrtec promotional vehicles. Partnered with internal OTC Sales Strategy for shopper insights to develop the 1st in market Zyrtec Loyalty Reward program. Developed a Women’s Wellness marketing platform including sales forecast, ROI projections, and display. Designed and Implemented test of an Oral Care “Aisle of the Future” with regimen “Brush, Floss, Rinse” messaging to increase basket size and drive incremental sales. Supervision and control of production activities and in process Quality checks at shop floor of Tablets, Capsules, ointment and dry syrup in accordance with cGMP norms. Handling and operating of IPQC instruments like D.T. apparatus, Analytical balance, Friability apparatus (ROCHE), Leak test apparatus, Hardness tester (MONSANTO, PFYZER, CAMPBELL etc).
  • Man power handling, target achievements and allocation of daily work to manpower. Having JD ORACLE (systems application & processing of data management) knowledge related to production. Daily Planning, Production, Handling and Arrangement of material. To complete production schedule as per planning with quality and optimum utilization of resources. Maintain proper communication with other ancillary department like QA, QC, Engineering, Store and warehouses etc.
    Proper handling and maintaining of Primary & Secondary Packing materials. Online documentation like BMRs, BPRs & log cards. Proper training on SOP (standard operating procedures) and cGMP (current good manufacturing practices) guideline to manpower like machine operator & Subordinates to obtaining required skill and perform their duties. To ensure and maintain % yield & productivity as per standards & to work actively for further enhancing the yield and productivity. Preparation of daily production report, OPMD (output per man per day) report and Monthly WIP (Work in Process) report.
    To involve in validation of product and introduction of new formulation through technology transfer.
    Handling of production related deviations and change control. Handling of Training records.
  • Areas of Strength: Handling of Change control. Handling of Deviation, incident and Investigations. Equipment Qualification, Compression of tablets (D and B tooling ), 43,55,45, & 61 Station (CADMACH) SpecialPTK 43 station, tablet in tablet compression machine, filling of capsules(semi automatic hand filling ) etc. Compression of tablets 75 & 81 Station (ELIZA PRESS) Ointment (manufacturing, tube filling, packing.) Dry syrup (filling, labeling and packing) Coating (enteric, film and sugar coating) of tablets. Primary packing (ALU-ALU BLISTER RAPID PACK 2MP, SATELLITE ENGINEERING STRIP MACHINE, ELEMACH BLISTER, RAPID PACK BLISTER) Handling of JD oracle related work.
  • Responsible for customer service, product distribution, vendor management, and supply chain. Developed improvements in inventory monitoring resulting in cost savings. Manage quote to product delivery process for customers world-wide. Collaborate with international suppliers, customers, and sales representatives to promote successful business relationships, resulting in increased customer satisfaction and sales. Developed SOPs to ensure consistency and increase efficiency. Worked closely with Sales, Finance, Marketing, Quality, and Regulatory to ensure customer satisfaction. Developed and monitored metrics to prevent back order situations and delayed shipments. Met or exceeded all metrics.
  • Improved customer relationships after previous staff turnover. Built strong customer relationships. Exceeded the needs of customers to ensure customer delight. Successfully launched skin care product line. Implemented Salesforce CRM to streamline operations. Developed department SOPs to improve efficiencies. Collaborated with Quality and Regulatory to ensure compliance. Ensured good communication between all departments was maintained to ensure that quality products are delivered to the customer (Sales, Logistics, Quality, etc.). Assumed full accountability in promoting and advertising pharmaceutical products. Proactively took part in lectures, while also conducted physician visitations in offices and hospitals. Cultivated strong and productive relationships with key decision makers.
  • Solely handled the daily business operations and advanced effectual promotional offers. Ensured the delivery of quality customer service by addressing customer necessities. Keenly monitored competition by collecting marketplace information on pricing and merchandising techniques. Successfully sold pain management (Duragesic), GERD (Aciphex), Alzheimer’s (Reminyl), schizophrenia(Risperdal) pharmaceuticals to pain management, psychiatric, GI, and geriatric specialists within hospital settings across eastern Pennsylvania and New York. Leveraged expert product knowledge to develop speakers and thought leaders into product/company champions on a regional and national basis.
    Consistently distinguished self as a resource and business consultant to the customer by proactively providing helpful collateral such as clinical reprints. Achieved consistent sales growth as proven by national and regional rankings. Better positioned and differentiated products in the market in regards to safety and efficacy, by applying a solutions-selling approach to win changes in hospital protocols and prescribing algorithms.
  • Built credibility and trust with physicians by consulting with them on extreme treatment challenges to attain improved patient outcomes. Enhanced business opportunities by forging and maintaining a network of internal and external specialists to share best practices, protocols, and algorithms. Developed and implemented a budgetary control system using Excel spreadsheets that effectively optimized ROI. Facilitated more accurate sales analysis and trending by assisting with the implementation of a new computer software system that tracked sales activities with physicians. Educate physicians (orthopedists, neurologists, internal medicine/primary care, dermatologists, ophthalmologists, gastroenterologists, urologists, podiatrists, cosmetic surgeons etc.), on private label products/services and new delivery systems. Identify pharmacy needs and emphasized product benefits for enhancing patient care to facilitate sales. Personally opened over 50 accounts by actively prospecting for new customers, effectively prioritizing leads, and working with existing accounts to expand business and obtain referrals. Ensure a persistent and positive business relationship with accounts leveraging product expertise and exceptional territory management initiatives.
  • Utilized extensive medical knowledge to identify potential opportunities within existing client accounts resulting in increasing utilization and revenues. Maximize penetration opportunities by providing promotional items and product solutions. Use consultative selling techniques to identify solutions to meet customer needs. Deliver clinically-supported sales presentations, negotiated transactions and provide ongoing client support vital to optimizing customer satisfaction and retention. Keep clients informed of current product developments, new products in the market, and serve as a continual resource. Increased average monthly sales volume each month by continuously strengthening business relations. Received monthly bonus awards for exceeding sales quotas. Ranked in the top 25% of the sales and customer care representatives in the company.
  • Manage finished goods and raw materials inventory levels.
    Assure availability of materials upon forecast and market driven changes. Track quality issues then, engage in quality improvement programs within GMP guidelines. Assure finished goods are produced and shipped to comply with GMP
    guidelines on due dates. Key participant in new product implementation team. Provide updates throughout the supply chain concerning material issues. Lowered days of supply, improving cycle time from 187 days to 82 days. Led Vendor Managed Inventory Projects. Successfully led an obsolescence reduction program leading to $322,000 in savings.
    cGMP experience: FDA approval of world class manufacturing facility 3-4 months earlier than target Generated cost savings in MRO and critical inventory in excess of $270,000 over 2 yrs. Received “Star Award”. Served as Project Liaison in the reduction of critical vendor lead times for Material Master Items.
    Developed and managed metric tracking system for critical component resulting in 20% reduced cycle times; 5 % reduction in inventory. Extensive purchasing support for R&D, Pilot Plants achieving reduced costs and quick turn-around in material fulfillment.
  • Managed procurement of all MRO products, chemicals, and production supply items for a medical device/OEM/contract manufacturer; also served as Safety Coordinator.
    Managed procurement and planning of all raw materials, packaging, and production supply items for a contract supplement and pharmaceutical manufacturer with six manufacturing facilities. Researched, evaluated, and selected new suppliers; negotiated pricing and contracts; maintained relationships with over 100 different suppliers. Maintained cGMP (Current Good Manufacturing Practices) certification to ensure compliance with FDA. Managed two assistant buyers to ensure on-time production availability. Purchased domestic and international products and maintained database of over 6,000 items with current pricing. Maintained daily up-to-date purchasing schedule for production. Attended Supply-Side Trade Show each year (for manufacturers of foods, beverages, supplements and cosmeceuticals) to manage relationships with vendors and alternate suppliers. Provided support for Production, Inventory, R & D, Accounting, Sales, Graphics, Shipping, and Receiving.
  • Identified adverse events for all Novo Nordisk, Inc. products per FDA guidelines from customers via phone and email. Triage and evaluated quality complaints for all Novo Nordisk, Inc. products from customers via phone and email. Created and revised Siebel Call Center SOP to ensure local SOP requirements were met.
    Trained employees and external vendors on Siebel Call Center Database used to log customer calls and emails. Created Siebel Training Manual for Customer Care and Vendors’ staff.
    Systematized Customer Care Remedy information resource and uploaded all new and revised PRB approved Customer Care Scripts. Ran various ad hoc reports in Siebel database for trend analysis, sales tracking, and management review. Answered questions and provided solutions to patients and healthcare providers regarding Novo Nordisk, Inc. products, having a thorough, broad knowledge of all offerings. Collaborated with management to create Opt In Script aligned with SOP 125651.
    Worked with vendor, Epsilon, to track Opt In request for various marketing programs.
  • Achieving 2016 quota at 105% for the Giant Eagle Consumer Health Care business ($12MM shipments). Conducted market analysis and identified growth opportunities for Oral Care, Wound Care, Sanitary Protection and Women’s Health categories.
    Developed growth strategy with aggressive in-store and in market advertising for key brands that lead to sales trends that outpaced national consumption trends. Lead Private Label and Brand co-exist strategy using key shopper insights and market research.
    Executed best in class merchandising strategy for the First Aid “Aisle of the Future”. Received PINNACLE AWARD recognition for development of the Field Sales NACDS presentations.
  • Managed analysis of POS and shipment trends for J&J’s 4th largest OTC Drug customer ($145MM shipments). Competitive tracking and promotional analysis for the Zyrtec Launch, influenced Rite Aid’s PL pricing and development of new Zyrtec promotional vehicles. Partnered with internal OTC Sales Strategy for shopper insights to develop the 1st in market Zyrtec Loyalty Reward program. Developed a Women’s Wellness marketing platform including sales forecast, ROI projections, and display.
    Designed and Implemented test of an Oral Care “Aisle of the Future” with regimen “Brush, Floss, Rinse” messaging to increase basket size and drive incremental sales.
  • Achieving 2016 quota at 115% for the Giant Eagle Consumer Health Care business ($12MM shipments)
  • Conducted market analysis and identified growth opportunities for Oral Care, Wound Care, Sanitary Protection and Women’s Health categories
  • Developed growth strategy with aggressive in-store and in market advertising for key brands that lead to sales trends that outpaced national consumption trends
  • Lead Private Label and Brand co-exist strategy using key shopper insights and market research
  • Executed best in class merchandising strategy for the First Aid “Aisle of the Future”
  • Received PINNACLE AWARD recognition for development of the Field Sales NACDS presentations
  • Managed analysis of POS and shipment trends for J&J’s 4th largest OTC Drug customer ($145MM shipments)
  • Competitive tracking and promotional analysis for the Zyrtec Launch, influenced CVS’s and Rite Aid’s PL pricing and development of new Zyrtec promotional vehicles.
  • Partnered with internal OTC Sales Strategy for shopper insights to develop the 1st in market Zyrtec Loyalty Reward program
  • Developed a Women’s Wellness marketing platform including sales forecast, ROI projections, and display
  • Designed and Implemented test of an Oral Care “Aisle of the Future” with regimen “Brush, Floss, Rinse” messaging to increase basket size and drive incremental sales
Education
Expected in 05/2008 Bachelor Of Business | Business Administration And Management Thomas Edison State University, Trenton, NJ GPA:

By clicking Customize This Resume, you agree to our Terms of Use and Privacy Policy

Your data is safe with us

Any information uploaded, such as a resume, or input by the user is owned solely by the user, not LiveCareer. For further information, please visit our Terms of Use.

Resume Overview

School Attended

  • Thomas Edison State University

Job Titles Held:

  • Quality Assurance Associate
  • Manufacturing Operator
  • QA Analyst/Customer Business Analyst/Buyer

Degrees

  • Bachelor Of Business

By clicking Customize This Resume, you agree to our Terms of Use and Privacy Policy

*As seen in:As seen in: