GSK
Operational Quality Specialist
USA - Pennsylvania - Marietta · On-site · Full-time · Posted Aug 25, 2026
- Experience
- 2+ years in a regulated industry; 1+ years with GMPs and regulatory compliance requirements.
- Education
- Bachelor’s degree in biology, chemical engineering, or a life sciences field; a bachelor’s degree in another discipline is acceptable with technical depth achieved through professional experience.
About the job
Provides on-site quality oversight at a U.S. manufacturing facility, ensuring GMP compliance and supporting batch approvals, quality investigations, and lot release.
What you'll do
- Monitor production and laboratory operations, coach staff, and identify or escalate quality risks.
- Review and approve batch records and other GMP documentation, deviations, CAPA plans, and change controls.
- Support disposition and lot release, root-cause investigations, audits, and inspection readiness.
What they ask for
- Bachelor’s degree in biology, chemical engineering, or a life sciences field; another discipline is acceptable with technical depth gained through professional experience.
- 2+ years of experience in a regulated industry and a strong quality assurance background.
- 1+ years of experience with GMPs, NIH Guidelines, FDA and other regulatory agency compliance requirements.
- Experience with validation principles, aseptic processing, quality systems, FDA regulations, DMAIC root cause analysis training, and reviewing batch records and GMP documentation.
Nice to have
- Experience in biologics manufacturing or pharmaceutical manufacturing environments.
- Familiarity with inspection readiness, deviations, CAPA, change control, validation, and root-cause analysis methods such as DMAIC.
Tools
GMP, cGxP, NIH Guidelines, FDA, ALCOA+, DMAIC, CAPA, PQRs
Model-written summary · the original posting is authoritative