Masis Professional Group ยท 1 week ago
Quality Assurance Operations Supervisor
Bethlehem, PA
Full-time
Onsite
Senior Level, Lead/Staff
$90K/yr - $105K/yr
10+ years expMasis Professional Group is a well-established, FDA-regulated pharmaceutical manufacturing site in Bethlehem, PA. The Quality Assurance Operations Supervisor oversees GMP quality activities to ensure regulatory compliance and product quality, playing a critical role in batch record review, deviations, and complaint management.
Professional ServicesRecruitingStaffing Agency
Hiring Manager
Jodi Ann Ingerson
Responsibilities
Coordinate batch documentation review with manufacturing and packaging teams to support timely product release
Ensure AP I and drug product batches comply with GMP and regulatory requirements
Supervise daily activities of the QA Operations team
Mentor and coach team members while supporting succession planning
Review production and QC documentation prior to batch disposition
Ensure deviations, data integrity issues, and errors are investigated per internal procedures
Oversee QC data review and OOS investigations
Perform documented QA walkthroughs of manufacturing and packaging operations
Collaborate with global QA partners to support batch release activities
Manage the drug product complaint program , including investigations and reporting
Prepare QA metrics for weekly, monthly, and quarterly management meetings
Qualification
Required
10+ years of pharmaceutical or biotech industry experience
Experience with QMS tools such as TrackWise, EDMS, LMS, or similar
Working knowledge of 21 CFR Parts 210, 211, and Part 11
Preferred
Bachelor's degree preferred or equivalent experience
Part 820 familiarity preferred
Benefits
Competitive salary
Bonus eligibility
Excellent benefits starting day one
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