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Cleanroom manufacturing operator Chemical Operator Batch maker
Location: US-TX-Dallas
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Role: Manufacturing Operator I
Location: Plainsboro, NJ - 8536
Duration: 06 Months on W2
2nd shift - 3pm - 11:30pm M-F
Summary Description
Performs initial chemical processing and batch mixing such as enzymatic treatment of collagen, alkali treatment of collagen, tendon collagen prep, dispersion prep and lyophilization required to produce collagen-based products. Performs the set up, and operates all clean room manufacturing equipment. 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.
Supervision Received
Under the direct supervision of the area Supervisor or Group Leader
Essential Duties And Responsibilities - to perform this job successfully, an individual must be able to perform each essential duty satisfactory.
Operate, maintain, and troubleshoot process equipment utilized in the collagen business, and can make minor equipment adjustments as needed.
Responsible for performing precise measurements and using measurement equipment to accurately add chemicals to batches.
Blend, mix, pour, and load collagen prepped material into lyophilizing equipment.
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, 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 activities 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 handling, decontamination, and cleaning of production supplies, instruments, equipment to support all cleanroom production related activities
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
Desired Minimum Qualifications
The requirements listed below are representative of the knowledge, skill, and/or ability required for this position.
High School diploma or equivalent. Degree in related science.
Intellectt INC
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