Quality Assurance Supervisor
Germer International - Pharmaceutical RecruitingAllentown, PA, United Statesjob_description.job_card.variable_days_ago
serp_jobs.job_preview.job_type
- serp_jobs.job_card.full_time
job_description.job_card.job_descriptionBachelor’s degree required with Bachelor of Science preferred 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. Knowledge of 21 CFR part 820 Medical Device Regulations preferred.
Our client is seeking a Quality Assurance Supervisor to oversee batch documentation review and serve as a key liaison with Operations and ensuring that all documentation aligns with GMP standards.
Responsibilites
- 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
- 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
Education / Experience
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Quality Assurance Supervisor • Allentown, PA, United States