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Production Technician
2 months ago
Required Experience:
- Background in FDA regulated settings
- Familiarity with aseptic practices and cleanroom operations.
Role Purpose:
- The Production Technician will oversee daily manufacturing operations, which involve producing items within a controlled cleanroom atmosphere.
- This role encompasses key responsibilities such as:
- Ensuring all designated products are produced in compliance with organizational protocols and current Good Manufacturing Practices (cGMP) to meet client expectations and adhere to production timelines.
- Grasping the principles of aseptic methods to function effectively within Class 1,000 and Class 100 cleanroom environments, as well as other regulated areas.
- Conducting quality assessments on incoming and outgoing materials and finished goods.
- Organizing and arranging materials or products on shelves, racks, or bins following established inventory guidelines.
- Completing batch documentation accurately and promptly after each production shift.
- Formulating, finishing, and packaging all products manufactured at the facility with minimal supervision.
- Monitoring machinery and performing basic maintenance and cleaning tasks.
- Utilizing and documenting readings from laboratory and production equipment.
- Strictly adhering to written or verbal instructions provided by supervisors or plant management.
- Transporting crates from storage to packaging areas using hand trucks or dollies to fulfill production needs.
- Inspecting and packaging products by verifying the integrity of bottles, labels, and heat seals against established quality standards.
- Labeling, bagging, boxing, and palletizing finished goods in accordance with production deadlines.
- Contributing to the development and revision of Standard Operating Procedures (SOPs) to ensure they are accurate, current, and compliant with Good Manufacturing Practices.
- Reporting quality and safety concerns to the immediate supervisor.
- Maintaining up-to-date personal training records and assisting in the training of new employees as necessary.
- Ensuring cleanliness and organization within production areas.
- Undertaking special projects and additional responsibilities as assigned.
Work Environment:
- Regularly lifts and/or moves items weighing up to 25 pounds, with occasional lifting of up to 60 pounds; rarely exceeds 60 pounds.
- Handles hazardous materials with appropriate personal protective equipment (PPE).
- May require the use of protective clothing or gear, including gloves, freezer jackets, jumpsuits, safety eyewear, and footwear.
- May work in a cleanroom setting.