Operational Quality Specialist -QC

GSK • Marietta, PA

10d • Onsite

About The Position

The Operational Quality Specialist in Quality Control oversees QC quality-system activities for drug substance quality control and supports quality across manufacturing and testing operations. The role works closely with production, laboratories, engineering, and quality teams to protect product quality and patient safety, provide clear quality decisions, and foster a strong quality culture. Responsibilities include oversight of QC procedures and methods, unplanned events, change controls, CAPAs, validation, and other QMS activities. The specialist also advises QC managers and personnel on cGMP and quality assurance matters and provides on-the-floor QA support.

The role includes decisions affecting the quality and suitability of products made at the Marietta site, including clinical trial materials and commercial products. Decisions must comply with applicable USP, CFR, EP, and FDA requirements. The specialist manages multiple projects amid changing priorities, facilitates resolution of differing departmental views, and helps keep teams effective through change.

This is an on-site position at a United States manufacturing location, with regular presence in production and laboratory areas. Hybrid and remote work are not available.

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 and other regulatory agency requirements for validation and operations, and analytical and stability functions and compliance.
• Demonstrated ability to drive initiatives across multiple business units under tight deadlines.
• Strong communication and problem-solving skills, with the ability to work well with and influence people without direct reporting relationships.
• Ability to work in a complex matrix environment with urgency, flexibility, and accountability, and to embrace a multi-skilled, team-based culture.
• Proven record of providing excellent internal and external customer service.
• Commitment to accuracy and quality while meeting goals and deadlines.
• Ability to understand documentation requirements for QC testing and approve GMP quality control test methods for drug product.
• Regular presence in production and laboratory areas at the on-site manufacturing location.

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, such as Sterility testing USP <71>, Endotoxin testing USP <85>, and Bioburden testing.
• Experience in pharmaceutical or biologics manufacturing focused on drug substance or 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 initiate resolution or escalation of concerns involving deviations, CAPAs, change controls, validation, analytical method transfers, risk assessments, and PQRs.
• Advise and counsel QC managers and personnel on cGMP and related quality assurance matters.
• Comply with GMPs, EHS procedures and regulations, facility regulatory guidelines, and standard operating procedures.
• Provide on-the-floor QA support and perform QA operations activities, including documentation and logbook reviews and review of facility cleaning records during quarterly walkthroughs.
• Release laboratory rooms after Return to Service testing and manage laboratory-area status changes in response to maintenance work or unplanned events.
• Provide QA oversight of the Stability and Retention program for the GSK Marietta site.
• Approve GMP quality control test methods for drug product and understand documentation requirements for QC testing.
• Manage concurrent projects as priorities change and facilitate resolution of differing views among departments.
• Stay current on developments in the field and GSK standards, while meeting quality goals and deadlines.

What This Job Offers

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