GMP Manufacturing Support Specialist

Support daily GMP manufacturing operations by performing production sampling, managing batch documentation and GLIMS activities, and coordinating with cross-functional stakeholders to ensure accurate, timely, and compliant execution of manufacturing processes that enable product quality and batch release.

• Create production batches and print labels in GLIMS to support daily manufacturing operations.
• Print and review paper batch records to ensure accuracy, completeness, and GMP compliance.
• Enter GMP production data into GLIMS accurately and in a timely manner to support batch release activities.
• Aliquot production samples and deliver them to the Quality Control (QC) laboratory on time, ensuring right-first-time execution.
• Coordinate and communicate daily sampling schedules with stakeholders using the sample tracker, escalating issues as appropriate.
• Coordinate requested sample shipments to Denmark on an as-needed basis, ensuring compliance with applicable procedures and timelines.
• Collaborate effectively with cross-functional team members and local colleagues to support production and quality objectives.
• Perform minor document revisions and updates in accordance with document control procedures.
• Follow Standard Operating Procedures (SOPs) and Good Manufacturing Practices (GMP) while performing assigned responsibilities.
• Adhere to all safety, environmental, and company policies in the performance of assigned duties.
• Wear and safely operate a Powered Air-Purifying Respirator (PAPR) as required during sampling activities.
• Maintain clear, professional communication with internal stakeholders to ensure timely resolution of production and sampling issues.
• Support daily production operations by completing assigned tasks accurately, efficiently, and within established timelines.
• Perform other related duties as assigned to support manufacturing and quality operations.

• Moves equipment &/or supplies weighing up to 33 pounds within the facility using various body positions.
• Ability to do close precision work with their hands.
• Must be able to remain in a stationary position (sitting and standing) 50% of the time.
• NOT REQUIRED - corrected vision.
• Occasionally ascends/descends a ladder.
• May be required to work at elevated heights.
• Occasionally works around odorous &/or hazardous materials.

• Associate's degree in related field from an accredited university or an equivalent combination of education & experience required.
• 2-3 years of experience in an administrative field, preferably in a pharmaceutical environment preferred.
• Minimum of one (1) year of manufacturing experience in a pharmaceutical environment preferred.
• Ability to problem solve & navigate complex assignments preferred.
• Strong knowledge & experience using Microsoft Office applications including:
  Word, Excel, PowerPoint & Outlook required.
• Proficient knowledge (Static User) in LIMS system & PAS-X preferred.
• Experienced in team training or Qualified 4P Trainer preferred.
• Strong interpersonal, oral & written & communication skills, ability to efficiently communicate, both orally & in writing with peers & area management required.
• Demonstrated experience in practical problem solving & process improvements preferred.
• Demonstrates excellent organizational & planning skills with a high level of attention to detail required.