Masis Professional Group · 3 hours ago
Quality Assurance Compliance Specialist
Bethlehem, PA
Full-time
Onsite
Mid, Senior Level
$60K/yr - $75K/yr
5+ years expMasis Professional Group is a growing pharmaceutical manufacturing site expanding its QA team. They are seeking a Quality Assurance Compliance Specialist who will be involved in GMP operations, responsible for reviewing batch records, supporting documentation control, and assisting with regulatory audits.
Professional ServicesRecruitingStaffing Agency
No H1B
Hiring Manager
Jodi Ann Ingerson
Responsibilities
Review manufacturing & packaging batch records (paper + electronic) for product release
Review lab data and generate Certificates of Analysis (C of A)
Release product in SAP and generate quality reports
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 FDA and regulatory audits
Perform packaging line inspections as needed
Train new QA team members and provide QA cross-coverage
Support new product launches and special QA projects
Qualification
Required
Bachelor's degree in a science or technical field (Chemistry preferred) or equivalent experience
5+ years experience in a regulated industry (pharma or medical device)
Strong working knowledge of FDA regulations, GMPs, GDPs, and GLPs
Experience in manufacturing and/or packaging environments
Familiarity with quality systems and document control
Proficiency in Microsoft Office
Strong communication, problem-solving, and critical-thinking skills
Preferred
SAP, TrackWise, EDMS a plus
Benefits
Annual bonus
Excellent benefits package
Company
Masis Professional Group
Masis Professional Group specializes in recruiting professionals for permanent, temporary, and temporary-to-permanent positions.
11-50 employees
Funding
Current Stage
Early StageCompany data provided by crunchbase