GMP Training Lead
Zoetis
5 days ago
On-site
Atlanta, GA
Operations
Job Description (GMP Training Lead)
Responsibilities:
- Process owner for site GMP training; develop and deliver cGMP/cGDP training.
- Support training on contamination control and aseptic behavior for aseptic manufacturing, filling, and packaging of biological/biopharma products.
- Design, develop, implement curricula; conduct training per site procedures and global standards.
- Drive continuous process improvements; improve training execution/management.
- Audit/review personnel to evaluate training effectiveness; make decisions aligned with SOPs, Core Values, and regulatory guidelines (cGMP/cGDP/cGLP).
- Provide startup-to-full-operations and ongoing training support; coordinate annual training requirements.
- Administer SAP SuccessFactors LMS; facilitate new employee orientation and aseptic training (including gowning qualification and simulations).
- Conduct spot checks/audits; observe media fills; network with Global Aseptic Team; coordinate critical aseptic-process understanding.
- Integrate training into electronic documentation systems; leverage technology (incl. virtual reality).
- Partner with Operations, QC, and QA to improve training using incident/error/trend analysis; apply subject-matter knowledge (GMP/Regulatory, microbiology, cleanroom/environmental controls, aseptic technique, facility/flow, sterilization/bioburden).
Qualifications:
- BS (min.) + 8+ years in pharmaceutical manufacturing/packaging.
- Bachelor’s in engineering/biology/chemistry/microbiology/virology/immunology or related technical field.
Technical Skills/Requirements (required):
- Strong technical/analytical, presentation, adult learning, and technical writing skills.
- Working knowledge of pharmaceutical production methods and cGMP experience.
- Knowledge of FDA, APHIS, VMD, and USDA regulations (pharmaceutical/biological industry).
Preferred:
- Aseptic and biological product formulation (blend/fill/lyophilization), packaging, and/or testing experience.
- Lean/Six Sigma experience.
Physical/Work:
- Ability to stand/walk, perform frequent reaching/stooping/kneeling/push-pull/handling, lift 5–25 lbs, work 40 hours with overtime as needed; occasional cleanroom work.
Responsibilities:
- Process owner for site GMP training; develop and deliver cGMP/cGDP training.
- Support training on contamination control and aseptic behavior for aseptic manufacturing, filling, and packaging of biological/biopharma products.
- Design, develop, implement curricula; conduct training per site procedures and global standards.
- Drive continuous process improvements; improve training execution/management.
- Audit/review personnel to evaluate training effectiveness; make decisions aligned with SOPs, Core Values, and regulatory guidelines (cGMP/cGDP/cGLP).
- Provide startup-to-full-operations and ongoing training support; coordinate annual training requirements.
- Administer SAP SuccessFactors LMS; facilitate new employee orientation and aseptic training (including gowning qualification and simulations).
- Conduct spot checks/audits; observe media fills; network with Global Aseptic Team; coordinate critical aseptic-process understanding.
- Integrate training into electronic documentation systems; leverage technology (incl. virtual reality).
- Partner with Operations, QC, and QA to improve training using incident/error/trend analysis; apply subject-matter knowledge (GMP/Regulatory, microbiology, cleanroom/environmental controls, aseptic technique, facility/flow, sterilization/bioburden).
Qualifications:
- BS (min.) + 8+ years in pharmaceutical manufacturing/packaging.
- Bachelor’s in engineering/biology/chemistry/microbiology/virology/immunology or related technical field.
Technical Skills/Requirements (required):
- Strong technical/analytical, presentation, adult learning, and technical writing skills.
- Working knowledge of pharmaceutical production methods and cGMP experience.
- Knowledge of FDA, APHIS, VMD, and USDA regulations (pharmaceutical/biological industry).
Preferred:
- Aseptic and biological product formulation (blend/fill/lyophilization), packaging, and/or testing experience.
- Lean/Six Sigma experience.
Physical/Work:
- Ability to stand/walk, perform frequent reaching/stooping/kneeling/push-pull/handling, lift 5–25 lbs, work 40 hours with overtime as needed; occasional cleanroom work.