Role: Production Technician Location: Durham, NC Duration: 12 month Schedule: The hours will fluctuate weekly between either 8:00AM - 4:00PM and 3:00PM - 11:00PM
Overview: Join our Manufacturing Operations team dedicated to producing high-quality therapies for patients. This role involves working in a dynamic environment focused on safety and quality, contributing to the end-to-end processing of drug substances and products while fostering a culture of continuous improvement and teamwork.
Key Responsibilities:
Author, review, and/or edit operations and technical documentation (Batch Records, SOPs, Job Aides, training, and engineering documents) to support project and future operations
Identify and address compliance, environmental, safety, and process deviations while coordinating with appropriate personnel
Actively participate in team meetings, HAZOPS, waste walkthroughs, 5S, kaizen events, and other training/initiatives
Execute and own production targets for assigned areas, including cleaning, setup, operation, and troubleshooting of equipment
Maintain excellent recordkeeping and housekeeping
Drive a culture of continuous improvement by implementing and raising ideas to increase group success
Participate in activities supporting technical and OPEX functions such as Kaizen events and protocol execution
Maintain detailed knowledge of equipment and processes
Required Qualifications:
High School Diploma/GED or higher
Minimum of one (1) year of experience in a relevant field
Demonstrated written and verbal communication skills
Ability to successfully pass and maintain aseptic gowning qualifications
Computer literacy (internet browsers, e-mail, spreadsheets, word processing)
Willingness and ability to lift 50 lbs, bend, stoop, squat, crawl, twist, climb ladders, and wear a respirator
Successful completion of TB titer and Chest X-ray are required
Preferred Qualifications:
Minimum Associate's 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)
Familiarity with regulatory requirements and Good Documentation Practices (GDP)
Demonstrated ability to work both independently and as part of a team
Aseptic behaviors and techniques, cRAB/Isolator experience, and environmental monitoring experience are significant advantages
Applicant Notices & Disclaimers
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At SPECTRAFORCE, we are committed to maintaining a workplace that ensures fair compensation and wage transparency in adherence with all applicable state and local laws.The pay rate for this position is $21.00/hr.
