Performs manufacturing operations to produce pharmaceutical products.
- Operate and maintain production equipment.
- Weigh, measure or check components/materials to assure batches manufactured contain correct components/materials and quantities.
- Assist in execution of validation protocols for processes and equipment.
- Maintain records and a clean environment to comply with regulatory requirements.
- Read, Understand, and comply with Good Manufacturing Practices and Standard Operating Procedures.
- Properly completes production documentation (batch records, log books, etc.).
- Reports to supervision when a process deviation occurs.
- Completes required training and assists in training new operators.
- Perform production activities including: Line clearances, cleaning/sanitization, CIP and SIP process equipment, filter testing, operation of microsphere process equipment
- HS education or equivalent, 2 year degree or higher preferred and a minimum of 2 years experience in cGMP pharmaceutical manufacturing environment.
- Prior experience in bulk processing, compounding, or similar area is required.
- Thorough knowledge of cGMP. Basic knowledge of chemistry and biology. General knowledge of steam/dry heat sterilization theories.
- Ability to operate all types of production equipment; gown appropriately for aseptic operations. Team player committed to quality and working effectively with others. Motivated self-starter, results oriented, dependable, organized, efficient work traits, disciplined, and able to work with minimal supervision.
- Basic math skills and mechanical aptitude.
Ability to lift 40 pounds, stand for long periods of time, work gowned up for long periods of time, maintain good personal hygiene.
Unimpaired Manual Dexterity
Ability to accurately interpret sounds and associated meanings at volume levels consistent with interpersonal or group conversations. Ability to interpret letters and numbers when viewed on a personal computer screen, reports and other documents.