Production Support Specialist, cGMP Compliance
4 weeks ago
The Production Support Operator plays a vital role in ensuring the production of high-quality products in a sterile environment. This position requires strong attention to detail, effective communication skills, and the ability to work collaboratively as part of a team.
Key Responsibilities- Ensure compliance with cGMP standards and maintain accurate documentation
- Contribute to ongoing training and process improvement efforts to optimize production efficiency and product quality
- Support the timely manufacturing of parenteral products, including vial preparation, fill line operation, lyophilizer loading/unloading, and vial sealing
- Set up, operate, sanitize, and sterilize equipment and manufacturing areas within a cleanroom setting
- Prepare, wash, and sterilize vials, perform batch calculations and formulations, and ensure compliance with all relevant regulations and procedures
- High school diploma or general education degree (GED)
- Two (2) years related experience in production, manufacturing, and/or cleanroom preferred
- Ability to read, write, and interpret documents such as safety instructions, standard operating procedures, policies, and manuals
- Ability to write clearly and communicate effectively
- Ability to add, subtract, multiply, and divide into all units of measure, using whole numbers, common fractions, decimals, and percentages
- Ability to demonstrate understanding and effective application of written and oral instruction
The work environment is sterile, and aseptic gowning is required. Personal protective equipment (nitrile gloves, clean room socks, face-shields, safety glasses, aprons, steel-toed shoes, and powered air purifying respirators) is necessary, depending upon the task at hand. The employee may be exposed to wet and/or humid conditions, confined areas, and refrigerator or freezer temperatures when working in a sterile environment.
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