Scientist, QA Manufacturing Support Specialist

7 days ago


Gladsaxe, Gladsaxe Municipality, Denmark AGC Biologics Full time

About the Role:

The QA Manufacturing Support Scientist is a key member of the AGC Biologics team, responsible for ensuring the highest quality standards in our manufacturing operations. As a Quality Assurance Manufacturing Support Specialist, you will play a critical role in maintaining compliance with Good Manufacturing Practices (GMP) and ensuring the integrity of our products.

Key Responsibilities:

  • Provide real-time quality support to manufacturing operations, ensuring that all activities are conducted in accordance with procedures and GMP requirements.
  • Conduct regular audits and inspections to ensure compliance with GMP and company procedures.
  • Review and approve batch documentation, including batch records, logbooks, and validation/qualification documentation.
  • Collaborate with manufacturing teams to resolve issues and implement improvements in GMP compliance.
  • Participate in Gemba walks and conduct site systems audits to identify areas for improvement.
  • Support the development and implementation of quality procedures and protocols.
  • Review and approve deviations, change controls, and CAPAs.
  • Perform quality reviews and approvals of buffer and media MPRs.

Requirements:

  • Bachelor's and/or Master's degree in Natural Sciences or a related field.
  • Alternatively, certified laboratory technician with a degree in laboratory science, biotechnology, or medical laboratory technology, with 3-5 years of experience in a GMP environment in the pharmaceutical industry.
  • Experience with BPR/MPR review is a plus.
  • Previous biopharma experience is preferred but not required.
  • Strong working knowledge of GMP principles and guidelines.
  • Excellent written and verbal communication skills.
  • Ability to work in a fast-paced, matrix environment.
  • Capable of working to deadlines and prioritizing multiple tasks.
  • Flexibility to meet changing needs and priorities of the business.

Location: Copenhagen Site



  • Gladsaxe, Gladsaxe Municipality, Denmark Novo Nordisk AS Full time

    About the RoleWe are seeking a highly skilled Development Scientist to join our team at Novo Nordisk A/S. As a key member of our API Manufacturing Development department, you will play a critical role in the development and optimization of enzyme manufacturing processes.Key ResponsibilitiesOptimize enzyme manufacturing processes to improve efficiency and...


  • Gladsaxe, Gladsaxe Municipality, Denmark Novo Nordisk Full time

    About the RoleWe are seeking a highly skilled Senior Quality Assurance Specialist to join our Digital Health & Staffs Quality team at Novo Nordisk. As a key member of our team, you will be responsible for ensuring the quality and compliance of our digital health solutions, including health software, SaMD as a Service, and digital health partnership...


  • Gladsaxe, Gladsaxe Municipality, Denmark Novo Nordisk Full time

    About the RoleWe are seeking a highly motivated and experienced Quality Assurance Professional to join our Chemistry, Manufacturing and Control (CMC) Active Pharmaceutical Ingredients (API) QA team at Novo Nordisk.Key ResponsibilitiesEnsure compliance with regulatory requirements, quality standards, and company policies in the CMC API Development...


  • Gladsaxe, Gladsaxe Municipality, Denmark Novo Nordisk Full time

    Job SummaryThe Quality Assurance Specialist will be responsible for monitoring GxP compliance for various functional areas within Novo Nordisk, ensuring adherence to regulatory standards. This involves guiding and handling deviations, inspections, and change request cases. The ideal candidate will have a strong understanding of GxP requirements and ISO9000,...


  • Gladsaxe, Gladsaxe Municipality, Denmark Novo Nordisk AS Full time

    About the RoleWe are seeking a highly skilled and experienced Technical Specialist to join our Production Support team at Novo Nordisk A/S. As a Technical Specialist, you will play a crucial role in maintaining the prerequisites that allow production to operate smoothly without interruptions.Key ResponsibilitiesSetting strategic direction within HVAC and...


  • Gladsaxe, Gladsaxe Municipality, Denmark Alba Project Group ApS Full time

    About Alba Project Group ApSWe are a small but fast-growing consultancy company relying on extensive experience within the project management disciplines, including procurement management for large, complex projects for leading companies in the pharmaceutical industry.Job DescriptionWe are seeking a highly skilled Procurement Specialist to support our...


  • Gladsaxe, Gladsaxe Municipality, Denmark inforevision Full time

    Om stillingenVi søger en erfaren IT-specialist til at træde ind i vores supportteam og bidrage til at udvikle og driftes vores IT-infrastruktur og cloudløsninger. Du vil være en del af et tværfagligt team, der arbejder sammen for at sikre, at vores IT-systemer er stabile og effektive.Om arbejdsopgaverneArbejdsopgaverne vil omfatte:Support og...


  • Gladsaxe, Gladsaxe Municipality, Denmark Novo Nordisk AS Full time

    About the RoleWe are seeking a highly skilled Automation Specialist to join our team at Novo Nordisk A/S. As an Automation Specialist, you will play a key role in shaping our Operational Technology (OT) Security strategy and driving digital transformation across our global operations.Key ResponsibilitiesDevelop and implement OT security strategies to ensure...


  • Gladsaxe, Gladsaxe Municipality, Denmark Novo Nordisk Full time

    About the RoleWe are seeking a highly skilled and experienced Health and Safety Specialist to join our dynamic team in Corporate Facilities at Novo Nordisk. As an H&S Partner, you will play a critical role in driving the agenda on Health and Safety and collaborating across our organization of 300+ people.Key ResponsibilitiesDrive the H&S Agenda: Set...


  • Gladsaxe, Gladsaxe Municipality, Denmark Novo Nordisk AS Full time

    About the RoleWe are seeking a highly skilled Lean Operations Specialist to join our Global Contract Manufacturing (GCM) department at Novo Nordisk A/S. As a key member of our team, you will play a central role in optimizing our office-based production operations and coaching our leadership team on Lean methodologies.Key ResponsibilitiesPartner with...


  • Gladsaxe, Gladsaxe Municipality, Denmark Novo Nordisk AS Full time

    About the RoleWe are seeking a highly skilled Mechanical Engineer to join our team in Aseptic Manufacturing Engineering at Novo Nordisk A/S. As a Mechanical Engineer, you will play a critical role in optimizing and maintaining our production lines, ensuring the stability and reliability of our equipment across global sites.Key ResponsibilitiesEnsure the...


  • Gladsaxe, Gladsaxe Municipality, Denmark Ferrosan Medical Devices Full time

    About Ferrosan Medical DevicesFerrosan Medical Devices is a leading manufacturer of medical devices used in surgical care. Our portfolio includes hemostatic products and electromechanical devices that help surgeons and nurses control bleeding and avoid complications in surgical procedures.Role SummaryWe are seeking a Senior OT Infrastructure Specialist to...


  • Gladsaxe, Gladsaxe Municipality, Denmark AgainBio (Luabio Aps, Secondcircle Aps) Full time

    We are a pioneering biotech company, AgainBio (Luabio Aps, Secondcircle Aps), dedicated to revolutionizing the way we address the global CO2 problem. Our innovative approach involves fermenting CO2 into carbon-negative chemicals, transforming it from a global issue to a valuable solution.Our team has made significant breakthroughs in converting industrial...


  • Gladsaxe, Gladsaxe Municipality, Denmark Novo Nordisk Full time

    About the RoleWe are seeking a highly skilled and experienced Digital Health Quality Strategist to join our team at Novo Nordisk. As a key member of our Digital Health & Staffs Quality department, you will play a critical role in shaping the future of our digital health business strategy.Key ResponsibilitiesLead the Quality agenda to support Novo Nordisk's...


  • Gladsaxe, Gladsaxe Municipality, Denmark AGC Biologics Full time

    About AGC BiologicsAGC Biologics is a leading biopharmaceutical company dedicated to bringing hope to life by enabling life-changing therapies for patients worldwide. Our mission is to work closely with customers to improve patients' lives by introducing new biopharmaceuticals to the market.Job SummaryWe are seeking a detail-oriented and proactive Accounts...


  • Gladsaxe, Gladsaxe Municipality, Denmark Novo Nordisk Full time

    About the RoleWe are seeking a highly motivated and experienced Clinical Outsourcing Specialist to join our team at Novo Nordisk. As a key member of our Clinical Outsourcing Management department, you will play a critical role in supporting the clinical outsourcing process for Clinical Pharmacology Trials.Key ResponsibilitiesSupport the clinical outsourcing...


  • Gladsaxe, Gladsaxe Municipality, Denmark Novo Nordisk AS Full time

    About the RoleWe are seeking a highly experienced Senior Quality Improvement Specialist to join our Integrated Quality Leadership team at Novo Nordisk A/S. As a key member of our team, you will be responsible for leading pilot projects within our Workstreams to drive the transformation of our Quality Management and support our scaling ambition.Key...

  • Project Engineer

    1 week ago


    Gladsaxe, Gladsaxe Municipality, Denmark Alfa Laval Full time

    About the RoleWe are seeking a highly skilled Project Engineer to join our team at Alfa Laval. As a Project Engineer, you will be responsible for driving the technical aspects of our customer projects, focusing on the development and implementation of process systems.Key ResponsibilitiesDevelop and maintain process designs, including P&IDs, process flow...


  • Gladsaxe, Gladsaxe Municipality, Denmark Novo Nordisk AS Full time

    About the RoleWe are seeking a highly skilled and experienced Health and Safety Specialist to join our team at Novo Nordisk A/S. As a key member of our Corporate Facilities department, you will play a critical role in driving our Health and Safety agenda and collaborating with stakeholders across the organization.Key ResponsibilitiesDevelop and implement...


  • Gladsaxe, Gladsaxe Municipality, Denmark EMD Full time

    About EMDEMD is a leading provider of innovative solutions in the fields of Healthcare, Life Science, and Electronics. Our team of experts is passionate about using science and technology to enrich people's lives and make a positive impact on the world.The RoleWe are seeking a highly skilled Technical Applications Specialist to join our Process Solutions...