Operational Quality Specialist -QC

GSK • Marietta, PA

9d • Onsite

About The Position

The Operational Quality Specialist in Quality Control oversees QC quality-system activities for drug-substance quality control and supports quality standards across manufacturing and testing operations. Working with production, laboratory, engineering, and quality teams, the specialist helps protect product quality and patient safety through sound decisions, practical support, and clear communication. The position provides QC oversight for quality-system matters including SOPs, methods, unplanned events, change controls, CAPAs, validation, analytical method transfers, risk assessments, and PQRs, and advises QC managers and personnel on cGMP and quality-assurance issues.

The role also provides on-the-floor QA support, including documentation and logbook reviews and review of facility-cleaning records during quarterly walkthroughs. It is responsible for releasing laboratory areas after return-to-service testing, changing lab-area status following maintenance or unplanned events, and providing QA oversight of the Marietta site's Stability and Retention program. Quality decisions can affect product suitability and release of clinical-trial materials and commercial products, and must comply with applicable USP, CFR, EP, and FDA requirements. The specialist manages multiple projects amid changing priorities and helps resolve differing departmental views.

This position is based on-site at a U.S. manufacturing location, with regular presence in production and laboratory areas; hybrid and remote work are not available. The role approves GMP QC test methods for drug product and requires understanding of documentation requirements for QC testing.

Requirements

• Bachelor’s degree in chemistry, biochemistry, pharmaceutical sciences, or a related scientific discipline.
• At least 2 years of quality-control experience and experience overseeing quality-control testing.
• Experience with quality systems and QC laboratories, including validation, documentation, and compliance in a high-volume, rapid-turnaround release office or compliance department.
• Understanding of industry and scientific practices related to the business.
• Knowledge of GMPs, NIH Guidelines, FDA requirements, and other regulatory-agency requirements for validation, operations, analytical and stability functions, and compliance.
• Demonstrated ability to drive initiatives across multiple business units under tight deadlines.
• Strong communication and problem-solving skills, including the ability to work effectively with and influence people without direct reporting relationships.
• Ability to work in a complex matrix environment with urgency, flexibility, and accountability.
• Commitment to teamwork in a multi-skilled, team-based culture and a record of excellent internal and external customer service.
• Ability to stay current on developments in the field and GSK standards, while maintaining accuracy and quality in meeting goals and deadlines.
• Understanding of documentation requirements for QC testing.

Nice To Haves

• Prior experience with licensed biopharmaceutical or biological products.
• Hands-on experience with analytical laboratory equipment or systems such as HPLC, GC-MS, TOC, FTIR, or ELISA.
• Hands-on experience with aseptic environmental monitoring programs and microbiological testing methods, including USP <71> sterility testing, USP <85> endotoxin testing, and bioburden testing.
• Experience in pharmaceutical or biologics manufacturing focused on drug-substance or drug-product testing.
• Knowledge of laboratory information management systems (LIMS) or electronic lab notebooks.
• Training or experience in root-cause analysis and structured investigation techniques.
• Experience supporting regulatory inspections and audit-readiness activities.
• Ability to influence and coach laboratory staff and cross-functional teams on quality behaviors.
• Comfort working in a fast-paced environment with multiple priorities.

Responsibilities

• Oversee QC-related quality-system activities and take initiative to resolve or escalate concerns involving deviations, CAPAs, change controls, validation, analytical method transfers, risk assessments, and PQRs.
• Advise QC managers and personnel on cGMP and related quality-assurance issues.
• Demonstrate familiarity with and compliance with GMPs, EHS procedures and regulations, facility regulatory guidelines, and standard operating procedures.
• Provide on-the-floor QA support and perform operational QA activities, including documentation review, logbook review, and facility-cleaning-record review during quarterly walkthroughs.
• Release laboratory areas after return-to-service testing and manage lab-area status changes in response to maintenance work or unplanned events.
• Provide QA oversight of the Stability and Retention program at the GSK Marietta site.
• Approve GMP quality-control test methods for drug product and understand documentation requirements related to QC testing.
• Manage multiple projects in parallel, adapt to changing priorities, maintain team engagement, and facilitate resolution of differing departmental views.
• Make quality decisions in accordance with applicable USP, CFR, EP, and FDA regulations.

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level