Quality Assurance QC Specialist-Drug Substance

About the role

We manufacture and supply reliable, high‑quality medicines and vaccines to meet patients' needs and drive our performance. Our network of 37 medicines and vaccines manufacturing sites delivered 1.7 billion packs of medicines and 409 million vaccine doses in 2024, helping improve the health of millions of people. Technology is transforming how we manufacture medicines and vaccines, enabling us to increase speed, quality and product supply. This position provides quality oversight for drug substance testing and laboratory control activities, working closely with QC analysts, lab leadership, manufacturing, and quality teams. The role offers hands‑on impact on product quality, opportunities to grow technical and leadership skills, and alignment with GSK's mission of uniting science, technology and talent to get ahead of disease together.

Responsibilities

• Provide operational QA oversight of the QC laboratory, including review and approval of test records, raw data, and certificate of analysis activities.
• Perform on‑floor lab walk‑throughs to observe testing practices, identify risks, and coach teams on good documentation and laboratory practices.
• Lead or support investigations into out‑of‑specifications, deviations, and laboratory incidents; document root‑cause analysis and follow through on corrective and preventive actions.
• Ensure compliance with cGMP, applicable regulatory requirements, product‑specific procedures, and product specifications.
• Support the preparation and management of regulatory inspections.
• Oversee all QC‑related quality system activities and resolve or escalate concerns, including deviations, CAPAs, change controls, validation, analytical method transfers, risk assessment, and PQRs.
• Provide advice and counsel on cGMP and related quality assurance issues to QC managers and personnel.
• Demonstrate familiarity and compliance with cGMPs, EHS procedures, facility regulatory guidelines and SOPs.
• Perform QA operational activities on the floor (documentation review, logbook review, facility cleaning records for Building 40, quarterly walkthroughs).
• Release rooms after Return‑to‑Service testing for Building 40 lab areas and manage status changes of lab areas in response to maintenance work or unplanned events.
• Provide QA oversight of the Stability and Retention program for the GSK Marietta site.
• Review and approve laboratory change controls, method transfers, and validation summaries relevant to drug substance testing.
• Support inspection readiness, internal audits, and self‑inspections of QC activities and laboratory systems.
• Monitor laboratory quality metrics and trends to identify opportunities for continuous improvement.
• Manage multiple projects in parallel, adapt quickly to changing priorities, and keep teams motivated.
• Facilitate resolution of opposing views among departments.

Basic qualifications

• Bachelor’s degree in chemistry, biochemistry, pharmaceutical sciences, or related scientific discipline; or equivalent experience.
• 2+ years of experience in a regulated QC laboratory or quality role in the life sciences industry.
• Experience with licensed biopharmaceutical or biological products and hands‑on use of analytical laboratory equipment/systems (e.g., HPLC, GC‑MS, TOC, FTIR, ELISA preferred).
• Experience with aseptic environmental monitoring programs and microbiological testing methods (Sterility test USP, Endotoxin testing USP, Bioburden testing).
• Experience in quality systems, Quality Control Laboratories, including validation, documentation, and compliance in a high‑volume, rapid‑turnaround release environment.
• Knowledge of GMP, NIH Guidelines, FDA and other regulatory agency requirements for validation, analytical and stability functions.
• Practical knowledge of Good Manufacturing Practices (GMP) and Good Documentation Practices (GDP).
• Experience reviewing laboratory records, raw data, and batch‑related documentation for compliance.
• Experience supporting investigations, deviations, or CAPA in a QC or laboratory environment.
• Strong attention to detail, clear written and verbal communication, and ability to work on‑site in a hands‑on role.

Preferred qualifications

• Experience with drug substance testing in a pharmaceutical or biologics environment.
• Familiarity with laboratory analytical methods such as HPLC, GC, spectroscopy, or wet chemistry techniques.
• Experience with laboratory information management systems (LIMS) or electronic lab notebooks.
• Training or experience in root‑cause analysis methods and investigation techniques.
• Experience supporting regulatory inspections and inspection‑readiness activities.
• Ability to influence cross‑functional teams and coach laboratory staff on quality behaviors.

Work arrangement

This position is on‑site at the GSK Marietta manufacturing location and does not allow hybrid or remote work. The employee will be expected to be present regularly in the laboratory and production areas; shift details and hours will be defined by the local site and may require flexibility.

Why you?

We welcome candidates who are curious, collaborative, and committed to continual improvement. The role requires regular presence in production and laboratory areas, and we value individuals who help create a respectful, supportive workplace.

Skills

• Data integrity
• Detail‑oriented
• Digital fluency
• GxP regulations
• Influencing without authority
• Lean management
• Pharmaceutical regulatory compliance
• Problem solving
• Quality assurance (QA)
• Risk awareness
• Technical writing