Tanzanique Annette Ketchens
Durham
Overview
23
23
years of professional experience
Work History
Manufacturing Compliance Specialist
BioMérieux
Durham
03.2026 - Current
- Conduct floor audits to identify safety hazards and verify PPE compliance.
- Review manufacturing batch records and logbooks to ensure accurate, compliant data.
- Provide on-the-spot coaching to operators on good manufacturing practices.
- Develop PowerPoint presentations for corrective action training addressing recurring errors.
- Maintain quality charts and error logs to monitor metric improvements.
- Coordinate with departments to ensure adherence to established standards.
Quality Assurance Specialist
Seqirus A CSL Company
Holly Springs
07.2021 - 02.2025
- Reviewed batch records for bulk, formulation, filling, and packaging areas to ensure compliance with quality standards.
- Reviewed logbooks, GLIMS forms, and redlines to verify accuracy and support regulatory compliance.
- Performed line clearance in filling, packaging, and bulk areas to maintain operational integrity and quality assurance.
- Perform Area walkthroughs for safety and quality.
- Provide on floor support to the manufacturing areas.
- Assignment of DOM and SLED date for commercial packaged lots.
- Review BAS alarms, Work notification, and provide assessment.
Oral Solid Dose Manufacturing Shift Lead
GlaxoSmithKline
Zebulon
04.2016 - 07.2021
- Manage second shift oral solid dose manufacturing daily schedule.
- Generated quality notifications via SAP and performed root cause analysis on second shift deviations using GPS and 5-step analysis, following up on CAPA action items and change controls.
- Reviewed manufacturing batch records to ensure compliance with quality standards.
- Perform line clearance for processing rooms and equipment to ensure the manufacturing area is clean and ready for production.
- Supported technical and mechanical departments in resolving equipment and process deviations to maintain production efficiency.
- Supported operators during the shift to facilitate daily operations.
- Provide the team with training for updated SOPs, CAPAs, and QN updates.
- Make decisions on a daily basis revolving around equipment, people, and processes to align with GSK KPIs.
- Participated in a test run for Zebulon EBRS and level one audit inspection.
Senior Bio-Process Technician
Merck
Durham
04.2011 - 04.2016
- Ensure all values are in a specified range, and good documentation practices are adhered to in accordance with federal regulations.
- Collaborate with Quality Assurance to resolve documentation errors and inventory discrepancies in SAP and MES automated systems.
- Perform operations review of bulk -cell/media batch records.
- Provide peer guidance for documentation corrections and communicate trending deviations.
- Coordinated with schedulers to ensure department schedule adherence, assigned shift activities, created and released orders, performed operations review, and terminated manufacturing orders.
- The team captain provided leadership, resources, and training for new employees.
- Resolved and troubleshot minor production issues to maintain operational flow.
- Formulate growth media for use in downstream processing.
- Performed internal media suite GMP walkthroughs and maintained current procedural training status to promote Right First Time and Safety.
Process Development Lab Associate
Cormetech
Durham
07.2010 - 04.2011
- Utilized Taber Abrasion instrumentation to assess resistance of new products in harsh environmental conditions.
- Prepared stock solutions to identify optimal concentrations for new products.
- Performed mechanical strength and moisture testing to evaluate product durability.
- Enter data into Minitab database and excel spreadsheets to create graphs for data presentation.
- Completed contract assignment
Manufacturing Associate
BioArray Solutions
Warren
04.2008 - 06.2010
- Set up and operated automated semiconductor packaging machinery, ensuring precision in processes like epoxy dispensing and wafer scribing.
- Performed reconstitution and assembly of DNA onto silicon chip blood typing products in a dynamic start-up environment.
- Organized and scheduled tasks to efficiently meet tight deadlines in production.
- Wrote/edited SOP's during migration from R&D start-up to ISO14971:2007 manufacturing facility.
- Collaborated with Quality Assurance on non-conformance disposition by identifying issues and drafting reports.
- Prepared and closed lot/batch production records.
Quality Control Lab Technologist II
International Technidyne Corp.
Edison
04.2004 - 04.2008
- Performed quality control testing of medical devices utilized in monitoring prescription drugs.
- Reviewed and authorized the release of QC tested products for packaging.
- Performed raw material, in-process and finished product testing.
- Identified non-conforming products through QC testing and recommended investigations to ensure compliance and product quality.
- Performed bioburden testing of production water supply.
- Managed stability program for marketed production lots to ensure product integrity throughout shelf life.
- Managed customer complaint system: initiated cases, performed physical testing, managed data, analyzed case closure trends, and initiated CAPA actions.
- Conducted blood tests in clinical environment.
Quality Control/ Formulation Lab Technician
Pharmaceutics Inc.
Morrisville
11.2002 - 03.2004
- Oversaw marketed stability program for pharmaceutics test cards and controls, ensuring compliance with quality standards.
- Performed quality control testing of medical devices utilized in monitoring prescription drugs.
- Conducted product performance investigations based on customer complaints and internal quality issues.
- Led monthly stability meetings to review results and address concerns or discrepancies with marketing, R&D, and technical support.
- Analyzed raw data using statistical methods to identify trends and patterns.
- Reviewed Device History Records for accuracy and currency.
- Supported production on proper lot sequence/expiration date encoding.
Education
B.S. - Biology
West Virginia State University
WV05-2000
Skills
- GMP compliance
- SOPs
- Deviation investigation
- Non-compliance assessments
- Quality improvements
- GMP
- GLP
- ISO
- FDA
- OSHA
- Batch record review
- LIMS
- Lab Vantage
- MES
- SAP proficiency
- Microsoft Office
- Agile
- SAP proficiency
Timeline
Manufacturing Compliance Specialist
BioMérieux
03.2026 - Current
Quality Assurance Specialist
Seqirus A CSL Company
07.2021 - 02.2025
Oral Solid Dose Manufacturing Shift Lead
GlaxoSmithKline
04.2016 - 07.2021
Senior Bio-Process Technician
Merck
04.2011 - 04.2016
Process Development Lab Associate
Cormetech
07.2010 - 04.2011
Manufacturing Associate
BioArray Solutions
04.2008 - 06.2010
Quality Control Lab Technologist II
International Technidyne Corp.
04.2004 - 04.2008
Quality Control/ Formulation Lab Technician
Pharmaceutics Inc.
11.2002 - 03.2004
B.S. - Biology
West Virginia State University