Quality Assurance Compliance Specialist | 2nd Shift
Bethlehem, PA
$65,000–$80,000 base + bonus + excellent benefits!
No C2C
A growing pharmaceutical manufacturing site has a full-time opportunity for a Quality Assurance Compliance Specialist to join a friendly, collaborative QA team.
Job Summary
Support GMP operations with a strong focus on batch record review, documentation control, and product release activities. This is a hands-on QA role in a regulated manufacturing environment with strong visibility and growth potential.
Key Responsibilities
- Review manufacturing and packaging batch records (paper & electronic) for product release
- Review laboratory data and generate Certificates of Analysis (C of A)
- Release product in SAP and generate quality reports as needed
- Support documentation control, archiving, and QA record management
- Review calibration records and support quality systems compliance
- Assist with deviations, investigations, APRs, CRNs, BOMs, and MBR updates
- Support internal and regulatory audits (FDA and other agencies)
- Support packaging line inspections as needed
- Train new QA team members and provide cross-coverage within QA
- Assist with new product launches and special QA projects
Qualifications
- Bachelor’s degree in a science or technical field (Chemistry preferred) or equivalent experience
- 3+ years of experience in a regulated industry (pharmaceutical or medical device)
- Strong knowledge of FDA regulations, GMPs, GDPs, and GLPs
- Experience in manufacturing and/or packaging environments
- Familiarity with quality systems and documentation control
- Microsoft Office proficiency; SAP, TrackWise, and EDMS experience a plus
- Strong communication, problem-solving, and critical-thinking skills.
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