Quality Assurance QC Specialist-Drug Substance

About the role

You will provide quality oversight for drug substance testing and laboratory control activities. You will work closely with QC analysts, lab leadership, manufacturing, and quality teams. This 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.

Oversee all Quality Control (QC) SOPs, QC Methods, unplanned events, Change Controls, CAPAs, continuous method validation, and QMS events for drug substance quality control activities. Drive excellence in Quality Control.

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.
• Provide QA oversight to ensure compliance with cGMP, applicable regulatory requirements, product specific procedures, and product specifications. Support the preparation and management of Regulatory Inspections.
• Provide oversight to all QC related quality system activities and take initiative to resolve and/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. Demonstrated familiarity and compliance with cGMPs, EHS procedures and regulations, facility regulatory guidelines and standard operating procedures.
• Provide on the floor QA support and perform QA Operation's activities (documentation review, logbook review, facility cleaning records for Building 40, quarterly walkthroughs).
• Responsible for release of the rooms after the Return to Service testing for the Building 40 lab areas and for status changes of lab areas in response to maintenance work or unplanned events.
• Responsible for QA oversight of the Stability and Retention program for the GSK Marietta site.
• Facilitate opposing views among departments to resolution. 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.

Principle Decisions / Complexity: Decisions made for Quality directly impact the quality and suitability of the products produced at the Marietta site including the release of clinical trial materials and commercial products. Decisions must be made in accordance with regulations of the USP, CFR, EP and FDA. Manage a high number of projects in parallel. Priorities can change very quickly due to new business opportunity or new sales projection. High adaptability required for ability to keep teams motivated when priorities change.

Requirements

• 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.
• Must have experience with licensed biopharmaceutical or biological products with hands on experience using Analytical laboratory equipment/systems, such as HPLC, GC-MS, TOC, FTIR, ELISA is preferred.
• Experience with Aseptic Environmental Monitoring programs, microbiological testing methods, such as, Sterility test USP, Endotoxin testing USP, Bioburden testing.
• Experience in quality systems, Quality Control Laboratories, including validation, documentation, compliance in a high volume, rapid turnaround release office or compliance department.
• Technical understanding of industry and science practices related to business.
• Versed in GMP’s, NIH Guidelines, FDA and other regulatory agency requirements for validation and operations, analytical and stability functions and compliance.
• 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 and does not allow hybrid or remote work. You will be expected to be present in the laboratory and production areas regularly. Shift details and hours will be defined by the local site and may require flexibility.

Benefits

Please visit GSK US Benefits Summary to learn more about the comprehensive benefits program GSK offers US employees.

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