Careers at Masis Staffing Solutions

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.

#MPG1