Quality Assurance Compliance Specialist

Job Title: Quality Assurance Compliance Specialist
Location: Bethlehem, Pennsylvania
Hours: 2nd shift (approx. 3:00 PM – 11:30 PM; some flexibility)
Type: Direct Hire
Compensation: $70000 - $75000 annually

Position Overview:
Our client is seeking a Quality Assurance Compliance Specialist to support GMP manufacturing operations at its Bethlehem, PA site. This role reports into senior QA leadership and plays a key part in batch record review, compliance oversight, and on-the-floor quality support for inhalation product manufacturing.
The position is primarily aligned to 2nd shift operations, with an initial 6-week training period on day shift. The individual will support packaging and manufacturing quality activities, ensure compliance with cGMP requirements, and contribute to deviation management, CAPA, and change control processes.
This is a strong opportunity for someone seeking a stable, focused QA environment with meaningful responsibility and limited daily interruptions.
Responsibilities:

• Perform detailed batch record review, including electronic batch records, ensuring accuracy and GMP compliance
• Review materials, components, packaging records, and labeling documentation within unified batch documentation
• Support investigations, deviations, CAPA, and change control activities
• Provide on-the-floor QA oversight for packaging lines, including filling in as needed during shift coverage gaps
• Ensure compliance with internal quality systems and regulatory expectations
• Collaborate cross-functionally with QC and manufacturing teams
• Support internal and external audit readiness
• Batch record review timelines typically range from 1–4 days depending on complexity. Performance expectations are metric-driven but not rigidly structured

Requirements:

• BS degree preferred AS degree with relevant experience considered
• 5–10 years of GMP Quality Assurance experience
• Strong batch record review experience required
• Electronic batch record experience required
• Experience with CAPA, deviations, investigations, and change control
• Experience supporting packaging or manufacturing floor quality activities
• Previous off shift experience preferred

System One, and its subsidiaries including Joulé, ALTA IT Services, and Mountain Ltd., are leaders in delivering outsourced services and workforce solutions across North America. We help clients get work done more efficiently and economically, without compromising quality. 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.

System One is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex (including pregnancy, childbirth, or related medical conditions), sexual orientation, gender identity, age, national origin, disability, family care or medical leave status, genetic information, veteran status, marital status, or any other characteristic protected by applicable federal, state, or local law.

Ref: #558-Scientific