Job Title: Senior Quality Assurance Compliance Specialist
Location: Bethlehem, PA
Type: Direct Hire
Compensation: $80,000-$90,000
Work Model: Onsite
Hours: 7:00 AM - 7:30 PM, 2-2-3 Schedule
Responsibilities
- Support Quality Assurance activities for 24/7 manufacturing operations and production schedules
- Review batch records and approve Certificates of Analysis (CoA)
- Conduct deviation investigations and manage CAPAs
- Oversee Change Control processes and internal audits
- Support regulatory audits and prepare documentation for compliance
- Perform Annual Product Reviews (APR) and handle vendor complaints
- Administer Document Control and eDMS systems
- Revise Standard Operating Procedures (SOPs) and conduct quality trend analysis
- Support supplier approval programs and maintain compliance with quality systems
Requirements
- Bachelor's degree in a scientific, quality assurance, or technical field
- 5+ years of pharmaceutical Quality Assurance experience
- Strong knowledge of cGMP regulations
- Experience with deviations, CAPAs, change controls, and investigations
- Document Control / eDMS experience
- Strong understanding of Quality Systems, CSV, and GAMP
- Excellent communication and cross-functional collaboration skills
System One not only serves as a valued partner for our clients, but we offer eligible employees health and welfare benefits coverage options including medical, dental, vision, spending accounts, life insurance, voluntary plans, as well as participation in a 401(k) plan.
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Ref: #558-Scientific
