Supervisor Aseptic Biologic Analyst III Resume Example Bio Rad

SUPERVISOR ASEPTIC BIOLOGIC ANALYST III

Professional Summary

Experienced Supervisor Aseptic Biologic, using critically thinking for problem solving is essential for training, and providing mentorship to groups of 05-40+ employees in quality/assurance/production technicians across several shifts. Efficient experience following and meeting tight quality and production schedules following all regulatory guidelines from the FDA, EMA, ICH and other international entities. Demonstrated documentation management skills, ability to design and implement quality processes.

Skills

Immunology: Enzyme-linked immunosorbent assays (ELISA), immunofluorescence assay (IFA), Single Radial Immunodiffusion Bioassay (SRID)

Cell Culture: Aseptic techniques, Bioassay's, animal/ plant tissue culture, pH meter centrifuges, aseptic multichannel micro-pipetting, and cellular incubation.

Electrophoretic: sodium dodecyl sulfate polyacrylamide gel electrophoresis (SDS-PAGE), Western blot.

Chemistry: Wet labs, Using autoclave to dispose of biohazard material, as well as extensive certifications in laboratory BSL-1, BSL-2, BSL-3.

Microbiology: Streak to isolate, gram stain, cultures of different organisms Independently monitored, collected, evaluated and recorded all data pertaining to FDA regulations protocols.

Compliance: Change Controls, Controlled SOP, RAW documents, Log books, work sheet, Resolutions of Out of Specification (OOS), Corrective actions and preventive actions (CAPA), leadership through usage of Performance Improvement Plan (PIP).

Computer: Microsoft Word, Excel, PowerPoint, Trackwise. SAP, SOP, LIMS, Clinical Laboratory Instrument plus calibrations, IMMUlab, SCORE, Electronic Batch Records (EBR), Master Data in Manufacturing Execution System (MES) and Distributed Control System (DCS),

Languages: Bilingual ( main English - secondary Spanish)

Bayer's Awards: Leadership, Efficiency, Management

Work History

QC Supervisor II /Manager, 03/2021 to Current
Bio-Rad – City , STATE

Established and updated work schedules to account for changing staff levels and expected workloads.
Controlled costs and optimized spending via restructuring of budgets for labor, capital assets, inventory purchasing and technology upgrades.
Expanded cross-functional organizational capacity by collaborating across departments on priorities, functions and common goals.
Maximized performance by monitoring daily activities and mentoring team members.
Cross-trained existing employees to maximize team agility and performance.
Applied customer feedback to develop process improvements and support long-term business needs.
Developed and maintained relationships with customers and suppliers through account development.
Compiled data highlighting key metrics to report information, determine trends and identify methods for improving store results.
Prepared and recommended long-range plans for development of department personnel.
Delivered feedback to decision-makers regarding employee performance and training needs.
Supervises the quality control team and provides routine updates and metrics on outstanding commitments.
Ensures the quality of all GMP manufacturing activities, oversees batch review and disposition activities to meet specified timelines, and ensure the batch disposition process is robust and continually seek ways to improve the disposition process.
Adapt to changes in the work environment, manages competing demands and is able to deal with frequent change, delays or unexpected events.
Collects, monitors and analyzes data trends for product quality drift and takes action to proactively address product failure risk.
Provides advanced troubleshooting assistance and training as necessary.
Develop and cultivate quality culture into business practices and processes which support manufacturing activities.
Provide guidance for qualification and validation activities based on risk management principles and experience with ISO and applicable regulatory guidance.
Support QA Compliance activities as needed or assigned by the quality site head, support regulatory and client audits as required.

Supervisor Aseptic Biologic Analyst III, 12/2015 to 03/2020
BAYER – City , STATE

Performed compliant FDA regulatory aseptic clean lab environment routine processes related to formulation, sampling, filling, capping, and sterile processing for Kogenate and Kovaltry.
Liaison between Engineering Dept., Maintenance dept., Quality Assurance, Quality Control ongoing process and protocols.
Health, Safety, and Environment (HSE) complete compliance through monthly safety inspections with follow up which include any action items.
Managed product quality to guarantee compliance, Audits, ensured SOP procedures protocols with hard copy and systems.
Manage development, revision, of all Standard Operating Procedures (SOP), Policies, and most controlled documents.
Supervised/trained/mentor new and existing employees in sterile aseptic SOP procedures, protocols and gown qualifications to perform activities and interventions in Class A/B areas, Facility is 24/7 schedule with several shifts.
Met aggressive production and safety goals.
Data interpretation and providing data summaries for method development, validation, and testing.
Ensured processing sampling for lab, re-qualifications, maintenance, and calibration on all equipment in restricted A-F areas.
Monitored work environment Cleanroom area in accordance with FDA regulations in compliance with Current Manufacturing Practices (cGMP), Good Laboratory Practices (GLP), Good Automated Laboratory Practices (GALP), Good Weighing Practices (GWP) requirements and safety inspections, including development and completion of corrective and preventive actions (CAPA) and continuous daily update in logbooks.
Followed cGMP SOP's for management of stability, standards and control programs, Distributed Control System (DCS), Master Data in Manufacturing Execution System (MES), Electronic Batch Record( EBR), Enterprise Resource Management (ERP).
Excellent mentoring, training using Performance Improvement Plan (PIP) and validation of analytical methods to cGMP and GLP standards.
Maintained laboratories in safe compliant FDA regulatory state, tracked cycle counts and inventories in SAP, LIMS, Trackwise.
Exceeded goals through effective task prioritization/ great work ethic.
Helped managers make accurate decisions by tracking deviations from production targets with daily logs.
Resolved conflicts and negotiated mutually beneficial agreements between customers and employees with diverse background..
Resolved malfunctions with systems and programs through troubleshooting.
Performed system analysis, documentation, testing, implementation and user support for platform transitions.
Maximized team knowledge and productivity by effectively training, monitoring and directing employees in application of best practices and regulatory protocols.

Validation and Quality Control Analyst (SRID), 06/2014 to 04/2015
SANOFI PASTEUR – City , STATE

Performed testing to meet demands of batch release, production, validation, independent demand, and stability programs. Followed testing schedule defined by lab management. Validated SRID (Single Radial Immunodiffusion) test gels for batch release potency; performed staining, pressing, scanning, and documentation; stored all cell cultures, and performed script reading of culture.
Ensured product integrity by pulling samples, placing work orders, performing visual inspection of samples, preparing samples for testing, and conducting validation of instruments and reagents.
Conducted inspection, testing, and release of raw materials, strictly adhering FDA and CBER regulations to Standard Operating Procedures (SOPs), SWIs, CBER, Good Laboratory Practices (GLP), and Current Good Manufacturing Procedures (cGMPs) material specifications.
Contributed to development and maintenance of validation quality management system, which involved master computerized systems list, master validation schedule, and validation department SOPs. Training all laboratory and microbiology employees. Sterile Aseptic qualifications at 100% and micro-manipulations with cell culture cell line, PCR, Influenza, Dengue, and Yellow fever.
Managed environmental plates monitoring of aseptic manufacturing operations in Grade A, B, through F clean room environments plus other classified areas. Collected/evaluated all pertaining study report data
Maintained laboratories in safe, compliant state; tracked cycle counts, confirmations, and inventories in SAP, LIMS, and Trackwise.
Ensured 100% compliance with ISOtrain, LabWare, and Immulab. Performing Bioassay testing, updating procedures, and protocols also conducting training assessments and verifications of these subjects.
Directed projects; scheduled resources, trained employees, completed work orders and provided status reports to management.
Managed +QDCI safety/quality deliverables cost involvement whiteboard. Daily team group meetings
Liaised with team tasked with testing batch release of active pharmaceutical ingredients (API). Validated API batch release product.
Earned certifications in aseptic techniques, pipetting techniques, records and documentation of hard copy, and binding of all departmental raw data for batch release.
Identified and resolved variances to bring products in line with requirements.
Inspected batches and compared against standards to meet regulatory requirements.
Documented and executed detailed test plans and test cases and summarized and logged audit findings for reporting purposes.
Conducted data review and followed standard practices to find solutions.
Determined root cause of deviations and non-conforming results and implemented appropriate corrective and preventive actions throughout product development process.
Compiled and distributed weekly feedback to team leaders and managers to improve service time and quality while increasing productivity.
Performed cell-based potency and impurity assays for in-process, release and stability samples.
Adhered to safety and clean area procedures to comply with agency and regulatory mandates.
Inspected raw materials and finished products to verify quality and disposed items that did not meet safety requirements.
Participated in weekly meetings with IT department.
Collected and analyzed activity data and initiated, developed and recommended improvements to systems,processes and procedures to increase productivity and reduce cost.

Laboratory Assistant, Cancer Cell Culture Lab., 06/2013 to 05/2014
EAST STROUDSBURG UNIVERSITY – City , STATE

Supervised and managed multi-level groups of 05-40 personal, while preforming training of aseptic techniques/prepping for experiments. Performed multichannel micro-pipette, standard plate count, plate incubation and direct microscopic cellular count.
Measured cellular activity and colony-forming units (CFU). Cultured tissues and bacterial and viral isolates.
Maintained all Aseptic techniques/procedures, Lab notebook, protocols for laboratory during testing/non-testing.
Assisted students with procedures and experiments and aseptic techniques.
Prepared chemicals and agars/medium for undergraduate cell culture\immunology, chemistry.
Inventoried microbiology media and chemistry/organic chemistry chemicals.
Conducted trial experiment on biofilms for allied health microbiology lab.
Created indicators, pH buffers, unknown concentrations of stock solutions for organic chemistry experiments.
Prepared, embedded, cut, stained, mounted, labeled and catalogued tissue sections.

Immunology Lab Coordinator, 06/2013 to 05/2014
EAST STROUDSBURG UNIVERSITY – City , STATE

Prepped lessons\equipment for specific electrophoretic techniques including SDS-PAGE and ELISA.
Maintained lab notebooks, performed sterile housekeeping, and managed all aspects of immunology/cell culture lab.
Conducted DNA fingerprinting workshops for local high school students.
Set up multiple lab experiments for class; prepared equipment, reagents, assays, buffers and media for class experiments. Maintained supplies for lab and made weekly verbal/lab note reports to "Director of Biotechnology of East Stroudsburg University".
Conducted extensive initial training for instructors, student assistants and new employees to cover safety hazards of each laboratory.
Conducted training for student for multichannel micro-pipette and familiarity with all Laboratory equipment's, safety guidelines and all performing analysis testing.
Qualified students, instructors and new employees to handle microorganisms safely and adhere to all SOP protocols..

Education

Bachelor of Science: Biotechnology, 2014
EAST STROUDSBURG UNIVERSITY - City, State

Associate of Science: 2009
PASSAIC COMMUNITY COLLEGE - City, State

Resume Overview

School Attended

EAST STROUDSBURG UNIVERSITY
PASSAIC COMMUNITY COLLEGE

Job Titles Held:

QC Supervisor II /Manager
Supervisor Aseptic Biologic Analyst III
Validation and Quality Control Analyst (SRID)
Laboratory Assistant, Cancer Cell Culture Lab.
Immunology Lab Coordinator

Degrees

Bachelor of Science : Biotechnology , 2014
Associate of Science : 2009

Supervisor Aseptic Biologic Analyst III Resume Example

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