Quality Assurance QC Specialist-Drug Substance
GSK
August 19, 2026
On-site
Marietta, PA
Operations
Position Summary:
Provide quality oversight for drug substance testing and laboratory control activities. Oversee QC SOPs/methods, unplanned events, Change Controls, CAPAs, continuous method validation, and QMS events for drug substance quality control. Drive excellence in Quality Control.
Responsibilities:
- Provide operational QA oversight of the QC laboratory (review/approval of test records, raw data, CoAs).
- Conduct on-floor lab walkthroughs; coach teams on documentation and lab practices.
- Lead/support investigations (OOS, deviations, lab incidents), perform root-cause analysis, and ensure corrective/preventive actions.
- Ensure compliance with cGMP and applicable regulatory/product procedures/specifications; support Regulatory Inspections.
- Oversee QC quality system activities (deviations, CAPAs, change controls, validation, analytical method transfers, risk assessments, PQRs).
- Provide on-floor QA support and QA operations (documentation/logbook review, facility cleaning records for Building 40, quarterly walkthroughs).
- Release building 40 lab rooms after Return to Service testing; manage status changes for labs after maintenance/unplanned events.
- Oversee Stability and Retention program for the GSK Marietta site.
Basic Qualifications:
- BS in chemistry/biochemistry/pharmaceutical sciences or related; or equivalent.
- 2+ years in regulated QC lab/quality role.
- Hands-on experience with analytical equipment (HPLC, GC-MS, TOC, FTIR; ELISA preferred).
- Experience with aseptic environmental monitoring and microbiological methods (USP sterility, endotoxin, bioburden).
- Knowledge of quality systems, validation, and GMP/GDP; record/raw data review; investigations/deviations/CAPAs; strong communication and on-site, hands-on work.
Preferred Qualifications:
- Drug substance testing experience; LIMS/electronic lab notebooks; root-cause investigation training; regulatory inspection readiness; cross-functional influence/coaching.
Work Arrangement:
- On-site; no hybrid/remote. Regular presence in lab/production; schedule flexibility may be required.
How to apply:
- Apply and describe how your experience fits the responsibilities/qualifications; include concrete examples of laboratory quality improvements you led and how you supported teammates.
Provide quality oversight for drug substance testing and laboratory control activities. Oversee QC SOPs/methods, unplanned events, Change Controls, CAPAs, continuous method validation, and QMS events for drug substance quality control. Drive excellence in Quality Control.
Responsibilities:
- Provide operational QA oversight of the QC laboratory (review/approval of test records, raw data, CoAs).
- Conduct on-floor lab walkthroughs; coach teams on documentation and lab practices.
- Lead/support investigations (OOS, deviations, lab incidents), perform root-cause analysis, and ensure corrective/preventive actions.
- Ensure compliance with cGMP and applicable regulatory/product procedures/specifications; support Regulatory Inspections.
- Oversee QC quality system activities (deviations, CAPAs, change controls, validation, analytical method transfers, risk assessments, PQRs).
- Provide on-floor QA support and QA operations (documentation/logbook review, facility cleaning records for Building 40, quarterly walkthroughs).
- Release building 40 lab rooms after Return to Service testing; manage status changes for labs after maintenance/unplanned events.
- Oversee Stability and Retention program for the GSK Marietta site.
Basic Qualifications:
- BS in chemistry/biochemistry/pharmaceutical sciences or related; or equivalent.
- 2+ years in regulated QC lab/quality role.
- Hands-on experience with analytical equipment (HPLC, GC-MS, TOC, FTIR; ELISA preferred).
- Experience with aseptic environmental monitoring and microbiological methods (USP sterility, endotoxin, bioburden).
- Knowledge of quality systems, validation, and GMP/GDP; record/raw data review; investigations/deviations/CAPAs; strong communication and on-site, hands-on work.
Preferred Qualifications:
- Drug substance testing experience; LIMS/electronic lab notebooks; root-cause investigation training; regulatory inspection readiness; cross-functional influence/coaching.
Work Arrangement:
- On-site; no hybrid/remote. Regular presence in lab/production; schedule flexibility may be required.
How to apply:
- Apply and describe how your experience fits the responsibilities/qualifications; include concrete examples of laboratory quality improvements you led and how you supported teammates.