Masis Professional Group · 5 hours ago
Quality Assurance Compliance Specialist
Bethlehem, PA
Full-time
Onsite
Mid, Senior Level
$60K/yr - $70K/yr
5+ years expMasis Professional Group is a growing pharmaceutical manufacturing site seeking a Quality Assurance Compliance Specialist to join their collaborative QA team. The role involves supporting GMP operations with a strong focus on batch record review, documentation control, and product release activities in a regulated manufacturing environment.
Professional ServicesRecruitingStaffing Agency
No H1B
Hiring Manager
Jodi Ann Ingerson
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
Qualification
Required
Bachelor's degree in a science or technical field (Chemistry preferred) or equivalent experience
5+ 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
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