Manufacturing Associate 3, Visual Inspection (First Shift)
On-siteHolly Springs, North Carolina, United States
Job Summary
Lead, execute, and document manufacturing processing steps including pH, conductivity testing, and visual inspection while performing in-process testing and executing validation protocols per cGMP SOPs. Operate across Drug Product areas such as parts washing, autoclave operation, compounding, sterile filling with isolator technology, and manual/automated visual inspection. Assist and lead cycle counts, manage materials, and support projects improving manufacturing processes through training new colleagues and maintaining cGMP documentation. Coordinate daily shift activities to ensure smooth, safe operations and assist the lead with assigned tasks. Work a 24/7 shift schedule including weekends and potential nights.
Required Qualifications
- High school diploma or GED
- 4+ years of direct experience in a cGMP manufacturing environment
- Associate's degree
- 2 years of direct experience in a cGMP manufacturing environment
- Bachelor's degree
- Equivalent military training or experience
- Qualified experience on at least one unit operation
- Parts washer
- Autoclave operation
- Compounding/formulation
- Filling with isolator technology
- Manual/automated visual inspection
- Ability to work a shift schedule to support a 24/7 operation
- Weekends
- Potential nights
Desired Qualifications
- Bachelor's degree (preferably in Life Sciences or Engineering)
- BioWorks or BTEC Capstone cGMP coursework
- Ability to assist in troubleshooting and recommend solutions
- Strong verbal and written communication skills
- Knowledge of production equipment in your assigned unit operation(s)
- Basic understanding of manufacturing run cadence and order of shift activities
- Working knowledge of cGMP, safety, and operational procedures
- Ability to work effectively in a team environment
- Sound judgment and initiative
- Respiratory protection
- Hearing protection and enrollment in a hearing conservation program
- Ability to operate a motor vehicle or Powered Industrial Truck (PIT)
- Ability to discern audible cues
- 20/20 corrected vision
- Color differentiation
- Ability to ascend/descend ladders, scaffolding, and ramps
- Ability to work at heights greater than 4 feet
- Ability to stand and sit for prolonged periods
- Ability to perform repetitive motions with wrists, hands, and/or fingers
- Ability to operate machinery and/or power tools
- Ability to move objects up to 33 lbs
- Ability to bend, push/pull, and reach from 18" to 60" with twisting motions
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