GMP Operations Specialist

5 days ago


Durham, North Carolina, United States Spectraforce Technologies Full time
Job Title: GMP Cleaner

Job Summary:

We are seeking a highly motivated and detail-oriented GMP Cleaner to join our team at Spectraforce Technologies. As a GMP Cleaner, you will play a critical role in maintaining a clean and safe working environment in our manufacturing facilities.

Responsibilities:

  • Support project teams as a CUCO (Clean Up Change Over) SME through start-up, commissioning, qualification, and licensure.
  • Identify and address compliance, environmental, safety, and process deviations as appropriate while coordinating with relevant personnel.
  • Actively support production areas by performing CUCO for Production Support & Media, Drug Substance, and Drug Product.

Key Activities:

  • General Housekeeping/Facility & Equipment Cleaning
  • Performing Bowie Dick Tests/Leak for Autoclaves
  • Running Washers & Autoclaves
  • Cleaning Closed Restricted Access Barriers (cRABS)
  • Performing cRAB pre-checks (Seal Tests/Leak Tests/Glove Integrity Tests)
  • Fill Line Support
  • Material Management/Inventory Checks (Kitting and Staging Items)
  • Gowning Restocking
  • Filter Integrity Testing
  • Waste Management

Requirements:

  • High School Diploma/GED or higher
  • Demonstrated written and verbal communications skills
  • Must be able to successfully pass and maintain aseptic gowning qualifications
  • Computer literacy (internet browsers, e-mail, spreadsheets, word processing)
  • Must be willing and able to lift 50 lbs, bend, stoop, squat, crawl, twist, climb ladders, and wear a respirator

Preferred Qualifications:

  • BioWork Certificate (working in an FDA or similar regulated industry)
  • Experience with automated systems (MES, SAP)
  • 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

Working Conditions:

This role will initially be 1st Shift, Monday - Friday (7am - 3:30pm). Will transition to 3rd Shift, Sunday - Thursday (10pm - 6:30am) 3Q/4Q 2024.

What We Offer:

We offer a competitive salary and benefits package, as well as opportunities for professional growth and development.

How to Apply:

Apply now to join our team and take the first step towards a rewarding career in manufacturing operations.



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