Job Description:
POSITION SUMMARY
High-level position for persons to manufacture commercial scale batches.
MAJOR RESPONSIBILITIES
- Lead other operators and small groups as directed by the Supervisor.
- Production, filling, and inspection of pharmaceutical formulations.
- Assist with facility cleaning and operational maintenance.
- Assist with facility and process validations as required.
- Perform aseptic production operations and validations.
- Assist with environment and water system monitoring as required.
- Assist with clean room sanitization as required.
- Assist with RCRA and safety inspections as required.
- Document all work as required by CGMPs on a timely basis.
- Read and follow all company SOPs and guidelines.
- Abide by all safety requirements as defined by the company.
- Train newly qualifying personnel.
- Provide coaching and feedback for currently qualified personnel.
- Other tasks as assigned by the Supervisor.
COMPETENCIES
- General knowledge of the Scientific Method.
- General math skills, including simple algebra.
- Through knowledge of and adherence to Current Good Manufacturing Practices.
- General knowledge of chemistry and biology.
- General knowledge of steam/dry heat sterilization theories.
- General knowledge of HAZCOM, RCRA, and other Safety requirements.
- Good level of mechanical aptitude; ability to perform minor non-routine equipment adjustments and diagnose improperly operating equipment.
- General computer word processing/spreadsheet skills.
- General knowledge of and ability to participate in customer, internal and FDA audits.
- Excellent documentation skills.
- Ability to act in a leadership role as production situations demand.
- Ability to mentor newly hired and progressively qualifying personnel.
- Detail oriented.
- Willing to learn new tasks and skills.
- Works well in a team environment.
- Respond quickly to assignments.
- Readily adapts to changing job duties.
- Manages time well; ability to multi-task.
- Positive attitude.
- Effective written and verbal communication skills.
- Effective trainer (coach).
- Displays understanding of and promotes company and customer objectives.
Physical Requirements:
- Occasional periods of repetitive motion.
- Ability to gown in an aseptic manner for clean room operations.
- Walking, lifting, pushing and pulling carts, reaching, climbing, and bending may all be required.
- Ability to operate all types of production equipment
- Ability to read, understand, and follow company SOP guidelines.
- Ability to lift/move up to 50 lbs. Ability to team lift up to 100 lbs.
- Ability to stand in steel-toed shoes for a minimum of 7 hrs.
EDUCATION AND EXPERIENCE
Basic Qualifications:
- High school diploma or equivalent.
- 4-5 years of experience in a pharmaceutical operation.
Preferred Qualifications:
- Associate degree or higher in science/technical discipline
- 4-5 years of experience in a sterile pharmaceutical operation.
PDN-9d87e571-580b-48ad-ac1b-2f666d4c4207