The Clean Room Manufacturing Operator 1st shift works 7am - 3pm with occasional OT.
Performs post-formulation processing such as product cutting, inspection, defect identification, packaging, machine packaging operations, and labeling and boxing in order to produce the finished good. Also performs sub assemble post chemical processing such as cross linking required to produce collagen-based products. All work streams include responsibility in the setup, operation and cleaning of all clean room manufacturing equipment. All chemical processing operations are performed in ISO Class 5 or ISO Class 7 areas and require proper Clean Room gowning. All processing is performed in compliance with Good Manufacturing Practices (GMP), Quality Systems Regulations), Standard Operating Procedures (SOP’s) and Health and Safety requirements. Operate in a team environment focused on daily milestones and quality throughput.
- Operate, maintain, and troubleshoot process equipment utilized in the collagen business, and be able to make minor equipment adjustments as needed.
- Responsible for performing precise measurements and using measurement equipment to accurately add chemicals to batches.
- Responsible for the cross linking, cutting, packaging and boxing of the product in its finished goods form, which includes performing visual product and component inspections to identify and remove defects.
- Pass and maintain gowning qualification to perform Gowning Requirement for ISO Class 5 Clean room operations or ISO Class 7 Clean room operations.
- Responsible for accurately maintaining legible and accurate records, required logs, books, records, and other procedures to comply with regulatory requirements, Good Manufacturing Practices (GMP), Quality Systems Regulations, Standard Operating Procedures (SOP’s), and Health and Safety requirements.
- Interface with QA/QC/Material departments during course of work to coordinate inspections and efficient flow of subassemblies and completed product.
- Enter and record production activies in Oracle MRP systems to issue material and labor hours to specific work orders.
- Follow applicable Standard Operating Procedures, Quality System Regulations and ISO 13485 requirements.
- Responsible for reporting all discrepancies to the Supervisor or Group Leader.
- Support department and plant Safety goals by continuously demonstrating safe behavior.
- Maintain a clean and orderly work area
- Ability to work flexible shifts, and flexible days within the week to meet batch milestone requirements
- Perform other manufacturing activities as assigned by the department leadership