States considered:
This position is responsible for executing department specific tasks in accordance with all applicable cGMPs and compliant with Corporate/site procedures, regulations, and policies.
Label Control: Maintain inventory and control approved label components per regulatory filings. Includes running labeling equipment per our local procedures.
Working Hours:
- 1st Shift: Monday - Thursday, 5:30AM - 4:00PM
- Must be available to work mandatory overtime on Fridays as needed.
Position Responsibilities:
- Execution of aseptic techniques and clean room procedures or support area procedures in a GMP facility.
- Maintain appropriate departmental cGMP documentation.
- Execute all written procedures, to include Batch Records and SOPs.
- Follow and comply with all financial procedures.
- Follow and comply with all site safety procedures.
- Operation of departmental equipment to include set up and take down.
- Effectively work in a team environment and communicate with multiple departments.
- Prepare approved labeling components for packaging department.
- Set up, run, tear down of labeling equipment.
- Complete inventory control of all regulatory approved labels.
- Work closely with packaging, QA, and shipping departments regarding schedules and regulatory compliance.
Education and Experience:
- High school education or GED required.
- Post High School education in the Sciences or other related disciplines preferred.
- Good mathematical, science and computer skills preferred.
- Demonstrated teamwork and collaboration skills required.
- Strong communication skills required.
Physical Requirements:
- Must be able to walk, sit, or stand for long periods of time.
- Must be able to reach above shoulder level, bend/stoop, kneel, push/pull, and handle/grip frequently.
- Must be able to work scheduled 40 hours with the ability to work mandatory overtime as needed.
- Frequent lifting and carrying of 5 to 45 lbs.
- Regular reaching, bending, stooping, and twisting.
- Repetitive motion and substantial movement of the wrists, hands, and/or fingers.
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