GMP Manufacturing Support Specialist

Job Description

Job Description

Job Title: GMP Manufacturing Support 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

Purpose 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. Essential Functions

• 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.

Physical Requirements

• 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

Qualifications

• 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

“Bring your attention to detail, positive attitude, and drive for quality to our team—apply today and help support the delivery of life-changing therapies!”

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. Click here for more information on benefits and perks that may be available to you as a member of the Kelly Talent Community.

Put your skills to work.

There are a lot of different light industrial jobs out there. Kelly® Professional & Industrial recruiters are focused on only offering opportunities with companies that provide competitive pay, safe work environments, and cultures that recognize your value. Whether you’re looking for flexible shifts, performance bonuses, or a progressive work culture-we’re dedicated to finding the very best opportunities for you.

About Kelly

Work changes everything. And at Kelly, we’re obsessed with where it can take you. To us, it’s about more than simply accepting your next job opportunity. It’s the fuel that powers every next step of your life. It’s the ripple effect that changes and improves everything for your family, your community, and the world. Which is why, here at Kelly, we are dedicated to providing you with limitless opportunities to enrich your life-just ask the 300,000 people we employ each year.

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