Principle Quality Assurance Specialist
2 weeks ago
AGC Biologics is seeking an experienced QA Scientist to join our team in Copenhagen. The successful candidate will be responsible for supporting Supply Chain, Process Transfer, and QC for late-stage and commercial products.
Key Responsibilities- Close collaboration with internal stakeholders
- Change control, deviation handling, and CAPAs
- Review and approval of material specifications
- Release of raw materials and disposables
- 3+ years of experience with Quality Assurance and/or material management
- Relevant academic background within pharmacy, biotechnology, biology, chemistry, or similar
- Proven experience in QA and/or material management
- Requirements for commercial and/or late-stage clinical phase GMP manufacturing of biological intermediates, APIs, and Cell Banks
- QA oversight and guidance of staff
- Experience with contract manufacturing and business understanding
- Deviation handling, including root cause investigations
- Review and evaluation of cGMP documentation
AGC Biologics is a global Contract Development Manufacturing Organization (CDMO) with bio-manufacturing facilities in Europe, Japan, Italy, and the USA. The company provides a comprehensive range of commercial and clinical cGMP biologics manufacturing services, from DNA to active pharmaceutical ingredient (API). We are committed to delivering high-quality products and services to our customers.
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Senior Quality Assurance Specialist
2 weeks ago
Gladsaxe, Gladsaxe Municipality, Denmark AGC Biologics Full timeAbout the RoleWe are seeking a highly motivated and detail-oriented Quality Assurance (QA) Scientist to join our team at AGC Biologics. As a QA Scientist, you will play a crucial role in ensuring the quality of our products and processes, adhering to Good Manufacturing Practice (GMP) standards.Key ResponsibilitiesOversee the quality assurance review and...
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Senior Scientist, Quality Assurance Specialist
2 months ago
Gladsaxe, Gladsaxe Municipality, Denmark AGC Biologics Full timeJob Title: Senior Scientist, Quality AssuranceWe are seeking a highly motivated and experienced Senior Scientist to join our Quality Assurance team at AGC Biologics. As a key member of our team, you will be responsible for ensuring the quality and integrity of our products and processes.Key Responsibilities:Oversee the Quality Assurance review and approval...
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Scientist, Quality Assurance Specialist
2 weeks ago
Gladsaxe, Gladsaxe Municipality, Denmark AGC Biologics Full timeQuality Assurance Specialist Opportunity at AGC BiologicsWe are seeking a highly skilled Quality Assurance Specialist to join our Quality Systems team in Copenhagen, Denmark.Key Responsibilities:Collaborate with partners to optimize GMP Training standards and systems.Develop new training standards, courses, and programs to support business needs and...
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Customer Service Quality Assurance Specialist
4 weeks ago
Gladsaxe, Gladsaxe Municipality, Denmark Novo Nordisk AS Full timeAbout the RoleWe are seeking a highly skilled and experienced Quality Assurance Professional to join our team at Novo Nordisk. As a Customer Service Quality Assurance Specialist, you will play a critical role in ensuring the quality and compliance of our customer service processes.Key ResponsibilitiesProvide quality assurance input on designing and...
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Quality Assurance Specialist for Validation
1 month ago
Gladsaxe, Gladsaxe Municipality, Denmark Novo Nordisk AS Full timeAbout the RoleWe are seeking a highly skilled Quality Assurance Specialist for Validation to join our team at Novo Nordisk A/S. As a key member of our CMC API QA department, you will play a critical role in ensuring the quality and safety of our products for clinical trials.Key ResponsibilitiesDevelop and implement quality strategies to ensure compliance...
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Gladsaxe, Gladsaxe Municipality, Denmark Novo Nordisk AS Full timeAbout the RoleWe are seeking a highly skilled IT Quality Assurance Specialist to join our team at Novo Nordisk A/S. As a key member of our Quality Control team, you will be responsible for ensuring the highest level of quality and compliance in our laboratory equipment.Key ResponsibilitiesDevelop and execute test plans and protocols for laboratory equipment...
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Gladsaxe, Gladsaxe Municipality, Denmark Novo Nordisk AS Full timeQuality Assurance Specialist RoleWe are seeking a highly skilled Quality Assurance Specialist to join our team at Novo Nordisk A/S in Bagsværd, Denmark.About the RoleThis is an exciting opportunity to work in a dynamic and professional environment where you will play a crucial role in ensuring the quality and safety of products for clinical trials.You will...
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Gladsaxe, Gladsaxe Municipality, Denmark Novo Nordisk AS Full timeAbout the Job:We are seeking a highly skilled Quality Assurance and Validation Specialist to join our team at Novo Nordisk A/S.Key Responsibilities:Set the quality direction for the capacity expansion projectDeliver best-in-class quality for qualification of equipment/facilities and IT-systemsHandle larger and complex quality issuesEnsure a LEAN culture and...
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Compliance Quality Assurance Specialist
2 weeks ago
Gladsaxe, Gladsaxe Municipality, Denmark AGC Biologics Full timeAbout the RoleWe are seeking a highly skilled Compliance Quality Assurance Specialist to join our Plant Engineering team. In this role, you will be responsible for ensuring compliance with regulatory requirements and maintaining high-quality standards in our facilities.Key ResponsibilitiesCollaborate with colleagues to maintain compliance and quality...
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Gladsaxe, Gladsaxe Municipality, Denmark AGC Biologics Full timeAbout UsAGC Biologics is a leading Contract Development and Manufacturing Organization dedicated to bringing new biopharmaceuticals to market.We strive to improve life quality by delivering dynamic solutions, technologies, and customized services for protein-based therapeutics and cell and gene therapies.Job DescriptionAs a QA Scientist, you will be a vital...
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Quality Assurance Specialist for Validation
4 weeks ago
Gladsaxe, Gladsaxe Municipality, Denmark Novo Nordisk AS Full timeAbout the RoleWe are seeking a highly skilled Quality Assurance Specialist to join our CMC API QA team. As a key member of our team, you will be responsible for ensuring the quality and compliance of our CMC API facilities and equipment.Key ResponsibilitiesDevelop and implement quality strategies to ensure compliance with regulatory requirementsConduct...
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Scientist, Quality Assurance Specialist
4 weeks ago
Gladsaxe, Gladsaxe Municipality, Denmark AGC Biologics Full timeAbout the RoleWe are seeking a highly skilled and experienced Quality Assurance Specialist to join our Quality Systems department. As a GMP Trainer, you will play a crucial role in enhancing our training standards to improve quality across the company.Key ResponsibilitiesCollaborate with partners to drive improvement projects optimizing our GMP Training...
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Customer Service Quality Assurance Specialist
2 weeks ago
Gladsaxe, Gladsaxe Municipality, Denmark Novo Nordisk AS Full timeAbout the RoleThe Digital Health & Staffs Quality department at Novo Nordisk A/S is seeking a highly skilled Customer Service QA Professional to join their team. As a key member of the department, you will be responsible for ensuring the quality and compliance of Customer Service processes across the organization.Main ResponsibilitiesAs a Customer Service QA...
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Advanced Quality Assurance Specialist
4 weeks ago
Gladsaxe, Gladsaxe Municipality, Denmark Novo Nordisk AS Full timeAbout the RoleWe are seeking a highly motivated and experienced Quality Assurance Professional to join our CMC API QA team at Novo Nordisk A/S. The successful candidate will support CMC API Development within the raw material and CMO shipping area.Key ResponsibilitiesEnsure compliance with regulatory requirements, quality standards, and company...
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Advanced Quality Assurance Specialist
1 month ago
Gladsaxe, Gladsaxe Municipality, Denmark Novo Nordisk AS Full timeJob Title: Advanced QA ProfessionalAbout the RoleWe are seeking a highly motivated and experienced Quality Assurance Professional to join our CMC API QA team. The successful candidate will support CMC API Development within the raw material and CMO shipping area.Key ResponsibilitiesEnsure compliance with regulatory requirements, quality standards, and...
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Gladsaxe, Gladsaxe Municipality, Denmark AGC Biologics Full timeJob Title: Associate Principal Scientist, Quality AssuranceWe are seeking an experienced Quality Assurance professional to join our team at AGC Biologics. As an Associate Principal Scientist, Quality Assurance, you will play a key role in ensuring the quality of our biologics manufacturing processes and products.Key Responsibilities:Support Supply Chain,...
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Customer Service Quality Assurance Expert
3 hours ago
Gladsaxe, Gladsaxe Municipality, Denmark Novo Nordisk AS Full timeAbout the RoleWe are seeking a highly skilled Customer Service Quality Assurance Expert to join our team at Novo Nordisk A/S in Søborg, Denmark.Job OverviewThis is a unique opportunity to shape the future of Customer Service in Novo Nordisk for the benefit of our patients across the world. As a Customer Service Quality Assurance Expert, you will work with...
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Quality Assurance Specialist
2 months ago
Gladsaxe, Gladsaxe Municipality, Denmark Novo Nordisk AS Full timeAbout the RoleWe are seeking a skilled QA Specialist to join our team at Novo Nordisk A/S. As a QA Specialist, you will play a critical role in ensuring patient safety by delivering high-quality standards for our products and production processes.Key ResponsibilitiesEnsure compliance with regulatory requirements and industry standardsReview and approve...
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Senior Scientist, Quality Assurance Expert
4 weeks ago
Gladsaxe, Gladsaxe Municipality, Denmark AGC Biologics Full timeAbout the Role: We are seeking a highly motivated and experienced QA Scientist to join our team at AGC Biologics. As a key member of our Quality Assurance department, you will play a vital role in ensuring the quality and compliance of our manufacturing processes and facilities.Key Responsibilities: As a QA Scientist, you will be responsible for:Reviewing...
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Gladsaxe, Gladsaxe Municipality, Denmark Novo Nordisk AS Full timeAbout the RoleWe are seeking a highly skilled IT Quality Assurance Professional to join our team at Novo Nordisk A/S. As a QA Professional, you will play a crucial role in ensuring the quality and reliability of our laboratory equipment and software.Key ResponsibilitiesDevelop and execute test plans and protocols for laboratory equipment softwareEnsure...