QC Senior Scientist (Microbiology)
GSK
August 10, 2026
On-site
King of Prussia, PA
Operations
Responsibilities:
- Conduct microbiological testing of lab samples (raw materials, drug product/substance, in-process materials, water, etc.).
- Perform bioburden testing and bacterial endotoxin testing (BET) per approved procedures/compendial requirements.
- Execute routine/non-routine testing for quality disposition supporting manufacturing, technical transfers, and special studies.
- Run growth promotion tests; qualify media and biological indicators.
- Perform microbial identification (gram stain, latex tests).
- Manage samples and documentation lifecycle in physical and electronic systems.
- Author/execute protocol studies (as applicable).
- Support/lead investigations, deviations, and assay troubleshooting with minimal supervision.
- Author/review/revise SOPs, URS, and controlled documents.
- Review/approve lab data for accuracy, completeness, and regulatory compliance.
- Perform GMP activities and maintain lab readiness (work orders, monitoring inspections, 5S, DMAIC, orange belt, change controls, inventory, etc.).
- Support/lead instrument lifecycle, technical transfers, and validation; act as SME; mentor analysts; support audits.
- Friday–Monday weekend shift; ability to work independently and collaborate across Quality, Manufacturing, and Technical Operations.
Basic Qualifications:
- Bachelor’s in Microbiology/Biology/Biotechnology (or related) + 5+ years hands-on microbiology lab experience
- OR Master’s + minimum 3 years in GMP-regulated environment
- Experience in GMP/GxP-regulated pharma/biotech/medical device/healthcare
- Bioburden and BET experience
Preferred Qualifications:
- Lab systems experience (SAP/ERP, LES/LES-EM, LIMS, ELN, WinKQCL, PyroTec PRO); Microsoft Office; Veeva
- cGxP/ICH/FDA and USP/EP/JP compendial knowledge; data integrity principles
- Automation platform knowledge; strong data analysis/trending and technical writing
- Weekend work ability on F–M schedule
Skills: Data integrity, detail-oriented, digital fluency, GxP regulations, lean management, problem solving, QA/QC, risk awareness, testing operations.
- Conduct microbiological testing of lab samples (raw materials, drug product/substance, in-process materials, water, etc.).
- Perform bioburden testing and bacterial endotoxin testing (BET) per approved procedures/compendial requirements.
- Execute routine/non-routine testing for quality disposition supporting manufacturing, technical transfers, and special studies.
- Run growth promotion tests; qualify media and biological indicators.
- Perform microbial identification (gram stain, latex tests).
- Manage samples and documentation lifecycle in physical and electronic systems.
- Author/execute protocol studies (as applicable).
- Support/lead investigations, deviations, and assay troubleshooting with minimal supervision.
- Author/review/revise SOPs, URS, and controlled documents.
- Review/approve lab data for accuracy, completeness, and regulatory compliance.
- Perform GMP activities and maintain lab readiness (work orders, monitoring inspections, 5S, DMAIC, orange belt, change controls, inventory, etc.).
- Support/lead instrument lifecycle, technical transfers, and validation; act as SME; mentor analysts; support audits.
- Friday–Monday weekend shift; ability to work independently and collaborate across Quality, Manufacturing, and Technical Operations.
Basic Qualifications:
- Bachelor’s in Microbiology/Biology/Biotechnology (or related) + 5+ years hands-on microbiology lab experience
- OR Master’s + minimum 3 years in GMP-regulated environment
- Experience in GMP/GxP-regulated pharma/biotech/medical device/healthcare
- Bioburden and BET experience
Preferred Qualifications:
- Lab systems experience (SAP/ERP, LES/LES-EM, LIMS, ELN, WinKQCL, PyroTec PRO); Microsoft Office; Veeva
- cGxP/ICH/FDA and USP/EP/JP compendial knowledge; data integrity principles
- Automation platform knowledge; strong data analysis/trending and technical writing
- Weekend work ability on F–M schedule
Skills: Data integrity, detail-oriented, digital fluency, GxP regulations, lean management, problem solving, QA/QC, risk awareness, testing operations.