Associate Technician Operations
$43,100–$67,800 year
On-siteDurham, North Carolina, United States
Job Summary
Support team as an operations expert through process performance qualification into commercial manufacturing. Author, review, and edit operations and technical documentation including Batch Records, SOPs, and training materials. Identify and address compliance, environmental, safety, and process deviations while coordinating with appropriate personnel. Attend daily huddles, HAZOPS, waste walkthroughs, and lean six-sigma training initiatives. Execute cleaning, setup, operation, and troubleshooting of equipment and facilities. Maintain detailed recordkeeping, housekeeping, and consumable inventory. Participate in Kaizen events and ad-hoc sampling activities. Complete TB titer and Chest X-ray screening. Work Monday through Friday from 6:00 AM to 2:30 PM.
Required Qualifications
- High School Diploma/GED or higher
- Demonstrated written and verbal communications skills
- Must be able to successfully pass and maintain aseptic gowning qualifications
- Must be willing and able to lift 50 lbs, bend, stoop, squat, crawl, twist, climb ladders, and wear a respirator
- Must be available Mon-Fri, Day Shift (6:00 AM to 2:30 PM)
- Successful completion of TB titer and Chest X-ray
- Computer literacy (internet browsers, e-mail, spreadsheets, word processing)
- Valid Driving License
Desired Qualifications
- Minimum Associates Degree in science or related field
- BioWork Certificate (working in an FDA or similar regulated industry)
- Applicable mechanical and project management experience
- Experience with automated systems (MES, SAP, DeltaV, or similar)
- Experience with on-the-floor cGMP manufacturing and familiarity with regulatory requirements and Good Documentation Practices (GDP)
- Demonstrated ability to work both independently and as a part of a team
- Aseptic Behaviors
- Aseptic Techniques & Manipulations
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