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Document Control Assistant

Kelly

Document Control Assistant

Kelly Services is seeking a detail-oriented and positive Sample Management Coordinator to support daily GMP manufacturing operations in one of our customer facilities in Durham NC. This contract role involves hands-on coordination of production sampling, batch documentation, and GLIMS activities to enable product quality, compliance, and timely batch release.

Key Responsibilities

  • Create production batches and print labels in GLIMS.
  • Print, review, and ensure accuracy of paper batch records for GMP compliance.
  • Enter production data into GLIMS promptly to support batch release.
  • Collect, aliquot, and deliver samples to the QC lab; ensure on-time and accurate handoffs.
  • Coordinate daily sampling schedules and escalate issues using the sample tracker.
  • Arrange sample shipments to Denmark as needed.
  • Collaborate with cross-functional teams to meet production and quality targets.
  • Revise and update documents per control procedures.
  • Follow SOPs, GMP, and safety policies; safely operate PAPR during sampling.
  • Maintain clear, professional communications and support timely issue resolution.
  • Complete assigned production tasks efficiently and with attention to detail.
  • Perform other duties as needed.

Required Qualifications

  • Associate's degree or equivalent combination of education and experience.
  • 23 years' administrative experience (pharmaceutical environment preferred).
  • At least 1 year of pharmaceutical manufacturing experience preferred.
  • Strong Microsoft Office skills (Word, Excel, PowerPoint, Outlook).
  • Proficient knowledge of LIMS & PAS-X preferred.
  • Effective team player with excellent communication and organizational skills.
  • Demonstrated attention to detail and ability to solve practical problems.

Physical Requirements

  • Move equipment/supplies up to 33 lbs within facility.
  • Precision handwork required.
  • Able to sit or stand 50% of work time.
  • Occasionally use ladders or work at heights.
  • May be exposed to odorous/hazardous materials.

Interested professionals with a strong team mindset and attention to detail are encouraged to apply!

Kelly
Vacancy posted 12 hours ago
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