On-Site Quality & Compliance Specialist (GxP)

Regulatory Jobs; Pennsylvania; On-site; USD 85,000 - 120,000; Full time

Job summary

GSK is seeking an on-site Quality Assurance professional at a United States manufacturing site in Pennsylvania to ensure cGxP compliance and oversee GMP processes across production and laboratory operations.

You will review batch records, CAPAs, and deviations, coach teams on quality behavior, and collaborate with QA Systems, Compliance and Product Release to uphold product quality and patient safety.

Qualifications

• Bachelor's degree in biology, chemical engineering, life sciences field or related discipline.
• 2+ years of experience in regulated industry with strong QA background; biologics experience preferred.
• 1+ years of experience with GMPs, FDA/NIH regulations and quality systems.
• Experience with validation principles, aseptic processing, quality systems and DMAIC root cause analysis.

Responsibilities

• Ensure all GMP processes and personnel adhere to current GMP and regulatory requirements; maintain inspection readiness.
• Maintain shopfloor oversight and be first line of contact for quality issues and escalations.
• Provide guidance during GMP activities to detect issues and prevent deviations.
• Perform spot-checks across production and lab areas for compliance with quality standards.
• Review cGMP documentation and records; ensure GDP and data integrity per ALCOA+; approve batch records.
• Review and approve deviations and CAPA plans; handle documentation revisions and change controls.
• Ensure GMPs, validation, safety and environmental regulations are met; model quality behavior and coach others.
• Provide on-the-floor quality oversight with walkthroughs; review deviations and master batch records; ensure completeness and compliance.
• Make or recommend disposition decisions; support internal audits and inspection readiness activities.
• Review and approve GMP documentation including change controls and validation summaries; assist with root cause analysis and CAPA implementation.

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

Education

Bachelor's degree in biology / life sciences

Job description

GSK is seeking an on-site Quality Assurance professional at a United States manufacturing site in Pennsylvania to ensure cGxP compliance and oversee GMP processes across production and laboratory operations.

You will review batch records, CAPAs, and deviations, coach teams on quality behavior, and collaborate with QA Systems, Compliance and Product Release to uphold product quality and patient safety.