Quality Assurance Compliance Specialist

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, and its subsidiaries including Joulé 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.