Germer International - Pharmaceutical Recruiting · 3 weeks ago
Supervisor, Quality Assurance Operations
Allentown, PA
Full-time
Onsite
Senior Level
$80K/yr - $110K/yr
5+ years expGermer International is a pharmaceutical recruiting company seeking a Supervisor for their Quality Assurance Operations. The role involves coordinating the disposition of API and drug products, ensuring compliance with GMP and regulatory requirements, and supervising the QA Operations team.
BiotechnologyPharmaceuticalRecruitingStaffing Agency
Hiring Manager
Jessica Gerber
Responsibilities
Overall responsibility for coordinating the disposition of API and drug product
Coordinates batch documentation review with Operations groups to ensure GMP compliance and timely delivery of products to customers
Ensures all documentation and API/drug product batches produced meet the requirements of GMPs and other regulatory health authority requirements
Supervises day-to-day functions of the QA Operations team
Mentors/coaches and provides succession planning for direct reports
Ensures batches meet GMP requirements and all production and QC documentation has been reviewed prior to disposition
If any errors or data integrity issues occur during the manufacturing, packaging, labelling, and testing of API/drug product, that they have been investigated according to internal procedures
Ensures QC data meets specifications and any OOSs are investigated per internal procedures
Provides QA presence on API/drug product filling/packaging line through documented walkthroughs to ensure GMP compliance
Works with global partners in EU/UK QA to ensure batches are dispositioned and records provided in a timely manner
Manages drug product complaint program ensuring samples are received in a timely fashion and investigations meet established internal procedural requirements and reports back to customer service team through approved software programs
Prepares metrics for weekly, monthly and quarterly Management meetings
Qualification
Required
Bachelor's degree required
5+ years' experience in Pharmaceutical/Biotech industry
Experience in TrackWise, EDMS, LMS or other such software tools for managing the QMS
Working knowledge of 21 CFR part 210/211, and part 11, FDA guidance
Preferred
Bachelor of Science preferred
Knowledge of 21 CFR part 820 Medical Device Regulations preferred
Company
Germer International - Pharmaceutical Recruiting
Welcome to Germer International! We're a Life Sciences search & placement firm that focuses on building long-term partnerships with small and mid-sized companies across the country.
11-50 employees
Funding
Current Stage
Early StageRecent News
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