About the position
The position involves inspecting GMP (Good Manufacturing Practices) vials, including both product and glass vials, for defects. The role also includes performing label and packaging activities for the finished product. The candidate will be responsible for ensuring compliance with standard operating procedures (SOPs) and current good manufacturing practices (cGMP).
Responsibilities
- Inspect vialed product and empty glass for defects
- Perform daily process activities in compliance with standard operating procedures (SOPs)
- Prepare all process-specific and ancillary equipment (i.e., glassware, apparatus) for use in assigned areas
- Assist in writing and implementing the area’s process documents
- Operate equipment in compliance with SOPs
- Assure compliance with cGMP requirements
- Work non-routine hours as required to maintain production schedule
- Perform label and packaging activities for the finished product
- Complete and review associated production records and daily trending
- Train new inspectors in accordance with vial inspector certification procedures
- Assist other manufacturing functions (Formulation, Fill, Materials) as required
Requirements
- High School Diploma or equivalent
- 1-3 years of pharmaceutical manufacturing or equivalent experience
Nice-to-haves
- 1+ year experience in a sterile pharmaceutical operation
- Associates degree or higher in a science/technical discipline
- Vial or general inspection experience preferred
- 4-5 years experience in pharmaceutical Manufacturing
- 2-3 years experience in a sterile pharmaceutical operation
- Training experience
