PCI Pharma Services is seeking to fill a Drug Product Inspection Trainer I position to administer visual inspection training and qualification for operators, ensuring the quality and compliance of drug products before they reach patients. This role is crucial for maintaining operational efficiency and adherence to cGMP regulations within the Drug Product Finishing operations.
Requirements
- Minimum one (1) year experience in Visual Inspection preferred
- Strong knowledge of visual inspection qualification exams and inspection / qualification SOPs.
- Working knowledge of sampling of finished product and LIM’s submission
- Working knowledge of Bulk Packaging and/or Labeling of Vials / Syringes and/or Product off-loading.
- Ability to pass Drug Product Trainer qualification exams.
- Strong and current knowledge of manual inspection techniques.
Responsibilities
- Administration of the test for qualification and re-qualification of visual inspection operators and a wide variety of tasks related to the visual inspection training program.
- Complete training and pass qualification testing for visual inspection of various product forms and pass Trainer specific qualification testing.
- Accurate visual inspection and handling of products following standard operating procedures (SOP’s) and working under cGMP regulations.
- Oversight of unit operations related to Drug Product Finishing operations as needed.
- Onboarding of new hires and managing qualifications, associated records and schedules.
- Provide 1-on-1 education, training and feedback to new and requalifying operators, including real-time feedback on the inspection floor.
- Execute any and all tasks, in Drug Product Finishing Operations, as assigned, for which they are currently qualified. Tasks include but are not limited to offloading, counting, sample submission, inspection, labeling and packaging, and product transfers to Materials Management.
Other
- High School Diploma or equivalent required.
- Bachelor’s degree in a Life Sciences discipline or equivalent training and experience preferred.
- Confidence and patience in all communications and training sessions.
- Detail oriented with strong written and verbal communication skills.
- Ability to work independently, within prescribed guidelines, or as a team member.
