GMP Manufacturing Support Specialist

GMP Manufacturing Support Specialist

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.

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

• 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

"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!"