GMP Quality Oversight Specialist

GlaxoSmithKline; Marietta (PA); On-site; USD 90,000 - 130,000; Full time

Job summary

GlaxoSmithKline is seeking an on-site QA professional to provide operational quality oversight at a United States manufacturing site. You will collaborate with production, labs, engineering and quality teams to ensure GMP compliance, safety and reliability, while supporting batch record review, deviations and CAPA decisions.

You will coach staff on quality behaviors, maintain inspection readiness, and drive continuous improvement in a fast-paced biologics/pharma environment at the Marietta site.

Qualifications

• Bachelor's degree in biology, chemical engineering, life sciences field or a bachelor's degree in another discipline is acceptable if technical depth has been achieved from professional experience.
• 2+ years of experience in regulated industry with strong quality assurance background; biologics manufacturing preferred.
• 1+ years of experience with GMPs, NIH Guidelines, FDA and other regulatory compliance requirements.
• Experience with validation principles, aseptic processing, quality systems; DMAIC root cause analysis; batch records and GMP documentation.

Responsibilities

• Ensure all GMP processes and personnel adhere to GMP, regulations and procedures; minimize non-compliance and maintain inspection readiness.
• Maintain shopfloor oversight; be first line of contact for quality issues and escalations.
• Provide guidance during GMP activities to detect quality issues in real time for timely interventions.
• Spot-check activities across production and lab areas for compliance in production, testing, cleaning and maintenance.
• Review cGMP documentation and records; ensure GDP per ALCOA+; review and approve batch records.
• Review deviations and CAPA plans; approve related documentation (PQRs, change controls, investigations, validation docs).
• Ensure GMPs, validation, quality, safety and environmental regulations are met; follow safety guidelines.
• Coach employees on procedures; communicate why non-compliance harms product quality and patient safety.
• On-the-floor quality oversight; perform walk-throughs; review batch records, deviations and CAPA for completeness.
• Support disposition decisions and lot release; assist with self-inspections and internal audits.

Skills

Data Integrity

Detail-Oriented

Digital Fluency

GxP Regulations

Influencing Without Authority

Lean Management

Pharmaceutical Regulatory Compliance

Problem Solving

Quality Assurance

Risk Awareness

Technical Writing

Education

Bachelor's degree in biology, chemical engineering, life sciences, or related field (or other discipline with technical depth)

Job description

GlaxoSmithKline is seeking an on-site QA professional to provide operational quality oversight at a United States manufacturing site. You will collaborate with production, labs, engineering and quality teams to ensure GMP compliance, safety and reliability, while supporting batch record review, deviations and CAPA decisions.

You will coach staff on quality behaviors, maintain inspection readiness, and drive continuous improvement in a fast-paced biologics/pharma environment at the Marietta site.