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 (https://www.mykelly.com/help-support-working-with-kelly-us/#Benefits) for more information on benefits and perks that may be available to you as a member of the Kelly Talent Community.
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About Kelly
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Kelly Services is proud to be an Equal Employment Opportunity and Affirmative Action employer. We welcome, value, and embrace diversity at all levels and are committed to building a team that is inclusive of a variety of backgrounds, communities, perspectives, and abilities. At Kelly, we believe that the more inclusive we are, the better services we can provide. Requests for accommodation related to our application process can be directed to Kelly's Human Resource Knowledge Center. Kelly complies with the requirements of California's state and local Fair Chance laws. A conviction does not automatically bar individuals from employment.
