Germer International - Pharmaceutical Recruiting
Quality Assurance Supervisor
Germer International - Pharmaceutical Recruiting, Allentown, Pennsylvania, United States, 18103
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
Bachelor’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.
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
Bachelor’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.