Barbara Watkin
Tamarac,Florida
Summary
Quality Analyst with excellent analytical, communication, problem solving, decision making, organizational and teamwork skills and the ability to deliver high level of quality service. SUMMARY OF QUALIFICATIONS Experience worker in the area of Quality within the Pharmaceutical manufacturing industry. Support Quality operation and environmental conditions. Maintain processes and methods and stay in compliance with company standards. Enforce, advice and report performance of quality areas and quality assurance requirements. Review non-conforming products and product risk assessment. Perform product failure and non-compliance investigation. Give supports to other departments and facilitate Quality improvements. Advance knowledge of government regulations and standards. Carries out responsibilities in accordance with the organization’s state, federal and local laws policies, procedures. Support good manufacturing and lab practices. Ability to prioritize, multi task, be efficient, flexible and detail-oriented. Great time management skills. Contribute to a friendly, productive workplace. Adhere to all company practices, procedures and safety rules. Proficient in Microsoft Office - Excel, Access, Word, and PowerPoint.
Overview
18
18
years of professional experience
Work History
Quality Specialist II
Teva Pharmaceutical
Fort Lauderdale, FL.
01.2013 - Current
- Perform on floor audits of manufacturing records, logbooks, Batch Records and other documentation.
- Perform daily Good Manufacturing Practice walkthroughs.
- Enforce and ensure the quality compliance of the manufacturing areas are in compliance with company and government regulations.
- Issuing, reviewing and disposition of Batch Records and other documentation.
- Implementing Corrective Action and Preventive Action for Quality operation.
- Provide group training and development and assist training department.
- Review and update Standard Operating Procedures and do Change Control.
- Collaborate with site operations in resolution of quality events and deviations.
- Completing and supporting the Event Response Team Form.
- Determine product impact and ensuring compliance.
- Review and approve work orders for equipment and facility.
- Maintain Quality Assurance documentation files, database and logs.
- Investigate and open deviations and enforce Corrective/Preventative action.
- Audit, review and revised Standard Operating Procedures as required.
- Perform verification of chemical and physical analyses studies of products through all stages of manufacturing.
- Conduct and collect routine and non- routine analysis and sampling of incoming raw materials, in- process and finished goods.
- Assist with product launches and special studies.
- Audit air pressure, temperature and humidity of production areas.
- Review Release and/or remove holds for swabs, rooms and equipment.
- Perform assays, calculation, attributes of in-process materials.
- Work on special projects/protocol and continuous improvement practices.
- Identify in process problems and open Queries and Trackwise reports.
- Complete and verify work orders and conduct sampling.
- Initiate and prepare change controls for Standard Operating Procedures.
- Conduct periodic reviews and effectiveness checks.
- Responsible for performing additional related duties as assigned.
Microbiology Technician Lead/ Quality Assurance
R.L. Schreiber
Pompano Beach, FL.
01.2008 - 01.2013
- Organized analysis of microbiological product and testing reports.
- Oversee and ensured compliance of quality and lab procedures.
- Reviewed, analyzed and evaluated microbiological results.
- Investigated deviations and implemented corrective actions.
- Supported Corrective and Preventive Action for Quality Operations.
- Inspected and approved products batch records, labels, lots and shelf life dates.
- Performed quality assurance audits and ensured proper documentation.
- Collected and prepared standards and chemical sample solutions.
- Used analytical for testing of raw, in-process and finished products.
- Inspected and conducted water and environmental sampling.
- Prepared sample for shipment to third party contract labs.
- Disposed of biohazard materials and reported danger.
- Followed aseptic procedures, cleaned and sanitized lab.
- Operated, troubleshoot and performed preventative maintenance on lab equipment.
- Conducted calibration, ensured recertification and assembled equipment.
- Prepared spreadsheets, filed and maintained database.
- Completed special projects for company advancement.
- Coordinated lab activities, trained employees and scheduled meetings.
- Reviewed batch records and standard operating procedures for accuracy.
- Authorized or rejected components and or work areas not in compliance.
Process Operator
Johnson and Johnson
01.2007 - 01.2008
- Ortho - Clinic Diagnostic/Micro typing (Kelly Scientific), Fort Lauderdale FL.
- Monitored sterilization process flow lines and operated machines.
- Developed, validated and implemented sterilization methods.
- Collected samples, performed test and analyzed results.
- Completed documentation and data entry.
- Reviewed sample requests and discrepancies.
- Maintained lab equipment and prepared dilutions.
- Monitored lab and production environment.
- Inspected labels, packaging, lot numbers, inserts.
Education
Certificate, Project Management Professional, Lean Six Sigma – Green Belt, FAU - undefined
2014
B.A - Healthcare Administrative Mgmt
Florida Atlantic University
2013
A.A.S - Marketing and Sales Mgmt
New York City Technical College
2004
B.Sc - Biochemistry
College of Arts Science and Technology, J.W.I
1993
Skills
- Calibration
- Continuous improvement
- Data entry
- Database
- Documentation
- Good Manufacturing Practice
- Government
- Materials
- Meetings
- Packaging
- Project Management
- Quality
- Quality Assurance
- Scientific
- Six Sigma
- Spreadsheets
- Troubleshoot
- Typing
Timeline
Quality Specialist II
Teva Pharmaceutical
01.2013 - Current
Microbiology Technician Lead/ Quality Assurance
R.L. Schreiber
01.2008 - 01.2013
Process Operator
Johnson and Johnson
01.2007 - 01.2008
Certificate, Project Management Professional, Lean Six Sigma – Green Belt, FAU - undefined
B.A - Healthcare Administrative Mgmt
Florida Atlantic University
A.A.S - Marketing and Sales Mgmt
New York City Technical College
B.Sc - Biochemistry
College of Arts Science and Technology, J.W.I
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