GMP Manufacturing Support Specialist

Job Title:

Documentation Area Specialist

Location:

Durham, NC Duration: 6 months (Temporary)

Schedule:

Onsite, Monday–Friday (5 days/week) Pay Rate: $33.69 Top

Skills:

• Attention to Detail
• Team Player/Positive Attitude
• Computer Literacy

Support daily GMP manufacturing operations by performing production sampling, managing batch documentation and GLIMS activities, and collaborating closely with cross-functional stakeholders. This associate will help ensure the accurate, timely, and compliant execution of manufacturing processes critical to product quality and batch release.

• Create production batches and print labels using GLIMS for daily manufacturing operations.
• Print and review paper batch records to confirm accuracy, completeness, and GMP compliance.
• Enter GMP production data into GLIMS accurately and on schedule to support batch release.
• Aliquot production samples and deliver them promptly to the QC lab, ensuring proper sampling.
• Coordinate and communicate daily sampling schedules with stakeholders via sample tracker.
• Arrange and ship samples to Denmark as needed, ensuring all policies and timelines are observed.
• Collaborate with cross-functional teams and local colleagues to achieve production and quality objectives.
• Make minor document revisions/updates in line with document control procedures.
• Follow all SOPs and GMP regulations for assigned responsibilities.
• Comply with safety, environmental, and company policies at all times.
• Wear and safely operate a Powered Air-Purifying Respirator (PAPR) as required.
• Maintain clear, professional communication with internal teams to resolve production and sampling issues quickly.
• Complete daily production tasks accurately, efficiently, and within established timelines.
• Perform other related duties as assigned to support manufacturing and quality operations.

• Move equipment/supplies up to 33 lbs within the facility
• Perform precise work with hands
• Remain in a stationary position (sitting/standing) for at least 50% of shift
• Occasionally use ladders and work at elevated heights
• Occasionally work around odorous or hazardous materials

• Associate's degree in a related field from an accredited university or equivalent combination of education & experience required
• 2–3 years’ experience in an administrative role, ideally in pharmaceuticals (preferred)
• 1+ year manufacturing experience in a pharmaceutical environment (preferred)
• Strong problem-solving skills and ability to navigate complex assignments (preferred)
• Proficient in Microsoft Office applications (Word, Excel, PowerPoint, Outlook) required
• Experience with LIMS system & PAS-X preferred
• Team training/Qualified 4P Trainer experience preferred
• CLean 1 Star certification a plus
• Strong interpersonal, oral, and written communication skills required
• Demonstrated organizational and planning skills with a high attention to detail required

As part of our promise to talent, Kelly supports those who work with us through a variety of benefits, perks, and work-related resources. Kelly offers eligible employees voluntary benefit plans including medical, dental, vision, telemedicine, term life, whole life, accident insurance, critical illness, a legal plan, and short-term disability. As a Kelly employee, you will have access to a retirement savings plan, service bonus and holiday pay plans (earn up to eight paid holidays per benefit year), and a transit spending account.

In addition, employees are entitled to earn paid sick leave under the applicable state or local plan.

Kelly may use AI-powered tools during the recruitment and hiring process. For full details, including how Kelly uses AI, your rights, and how to request a reasonable accommodation, visit the Recruitment Artificial Intelligence Notice () .

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