Manufacturing Associate
101 Southcenter Court Morrisville, NC 27560 US
Job Description
Job Description:?
- Participate in process validation activities and ongoing manufacturing for a new multi-product manufacturing facility.
- Develop a suitable level understanding of GMP manufacturing process(es) and be able to skillfully execute and troubleshoot them.
- Reviews and completes documentation to support production activities, including batch record events and management of forms and labels on the production floor.
- Conforms to established safety procedures in accordance with OSHA and other regulatory agencies.
- Develop a Subject Matter Expert (SME) level understanding of GMP manufacturing process(es) and be able to skillfully execute and troubleshoot them.
- Strong attention to detail.
- Ability to work safely in a manufacturing environment.
- Experience in aseptic operations required.
- Must be able to work in a clean room environment requiring special gowning including a face mask.
- Background in BSCs, isolators, aseptic gowning and qualification strongly desired.
- Experience with batch record execution, including good documentation practices.
- Individuals may be required to sit, stand, walk regularly, and occasionally lift 20-25 pounds.
Education:
A minimum of 2+ years of experience in a cGMP manufacturing environment along with a degree in science or a technical related discipline OR a minimum of 3+ years of cGMP manufacturing experience with a high school diploma is required.
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