Qa Specialist Ii - Ops
PCI Pharma Services · Bedford, NH
QualityFull-timeCompany career page
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Role summary
Quality Assurance Specialist supporting clinical and commercial pharmaceutical manufacturing at a contract manufacturing organization in Bedford, NH. Responsible for batch record reviews, deviation management, investigations, and CAPAs to ensure GMP compliance and product quality.
What they're looking for
- 5-7 years pharmaceutical or biotech industry experience; 3+ years in QA Operations role
- Bachelor's degree in relevant scientific discipline
- Root cause analysis, technical writing, and quality investigation experience
- Knowledge of FDA regulations (21 CFR Parts 210, 211, 820) and ICH guidelines
- Proficiency with risk management tools (FMEA, HACCP, PHA) and MS Office suite
- Strong organizational skills, attention to detail, and written/verbal communication
- ASQ certification preferred
What you'll be doing
- Review and approve batch documentation for clinical and commercial product release per cGMP and regulatory requirements
- Oversee deviation, investigation, and CAPA programs; approve quality investigations and corrective actions
- Review, develop, and approve quality system procedures, specifications, test methods, and change control documentation
- Lead quality improvement projects and serve as QA representative on cross-functional teams
- Interface with internal and external customers on compliance matters and prepare regulatory inspection readiness
Privacy & handoff
This role links to PCI Pharma Services's own application system. RoleLantern records your interest and checks the link, but the application happens on the employer's site and status updates may not come back to us. Clicking apply does not mark you as applied automatically.