Life Sciences Quality Assurance Specialist

2 days ago


Gladsaxe, Gladsaxe Municipality, Denmark AGC Biologics Full time
About Us

AGC Biologics A/S is a global Contract Development and Manufacturing Organization (CDMO) specializing in the development and manufacture of biopharmaceutical proteins. Our mission is to improve patients' lives by bringing new biopharmaceuticals to market.

We are committed to delivering high-quality products while maintaining a dynamic work environment that fosters innovation, teamwork, and customer satisfaction.

Job Description

We are seeking an experienced Life Sciences Quality Assurance Specialist to join our QC Bioassay team. The successful candidate will be responsible for ensuring compliance with current ICH guidelines and supporting the manufacturing production process.

As a key member of our QC team, you will play a crucial role in reviewing and approving analytical results, participating in method validations, and collaborating with cross-functional departments.

The ideal candidate will have a strong analytical mindset, excellent communication skills, and experience working in a cGMP setting. Fluency in English is required.

Key Responsibilities:
  • Review and approval of analytical results
  • Responsible for method validations according to current ICH guidelines
  • Participate in troubleshooting and scientific support on a broad range of bioassay methods
  • Drive compliance documents related to QC activities
  • Collaboration with multiple stakeholders both within QC and cross-functional departments
Requirements:
  • M.Sc. or Ph.D. degree in Life Sciences
  • Experience from the pharmaceutical industry, preferably from Quality Control or an Analytical Development department
  • A strong analytical mindset and troubleshooting skills
  • Excellent communication skills and a service-minded attitude
Benefits:
  • Competitive salary: € 70,000 - € 90,000 per annum
  • Benefits package including health insurance and retirement plan
  • Opportunities for professional growth and development


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

    About the JobWe are seeking a highly skilled Senior Quality Assurance Specialist to join our team at Novo Nordisk A/S. This role offers an exciting opportunity to work in a dynamic environment, driving quality and excellence in laboratory equipment and software.Job DescriptionThe successful candidate will contribute to ensuring high-quality standards in...


  • Gladsaxe, Gladsaxe Municipality, Denmark AGC Biologics Full time

    About the RoleWe are seeking a skilled Biopharmaceutical Quality Assurance Specialist to join our team at AGC Biologics in Copenhagen. As a vital member of our multidisciplinary team, you will play a crucial role in ensuring the quality and compliance of our production facilities and laboratories.Job SummaryThe successful candidate will be responsible for...


  • Gladsaxe, Gladsaxe Municipality, Denmark AGC Biologics Full time

    About the Role:As a Quality Assurance Specialist at AGC Biologics, you will play a critical role in ensuring the highest quality standards are met in our biopharmaceutical manufacturing processes. Located at our Copenhagen Site, this position offers an exciting opportunity to contribute to the development of life-changing therapies for patients...


  • Gladsaxe, Gladsaxe Municipality, Denmark AGC Biologics Full time

    Job DescriptionAbout the Role:We are seeking a highly motivated and detail-oriented Lead Quality Assurance Biopharmaceutical Specialist to join our Quality Assurance department at AGC Biologics. As a member of this team, you will play a critical role in ensuring that our production facilities and laboratories comply with current Good Manufacturing Practice...


  • Gladsaxe, Gladsaxe Municipality, Denmark AGC Biologics Full time

    About AGC BiologicsAGC Biologics is a leading global biopharmaceutical Contract Development and Manufacturing Organization (CDMO) with a strong commitment to delivering the highest standard of service. We provide world-class development and manufacture of mammalian and microbial-based therapeutic proteins, plasmid DNA (pDNA), messenger RNA (mRNA), viral...


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

    At Novo Nordisk A/S, we are committed to shaping the future of healthcare and improving the lives of millions of people worldwide. Our company is built on a strong foundation of innovation, quality, and collaboration, and we are now seeking a highly skilled Global Quality Assurance Manager to join our team.The successful candidate will play a critical role...


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

    We 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 A/S.The successful candidate will support CMC API Development within the raw material and Contract Manufacturer (CMO) shipping area. This role is responsible...


  • Gladsaxe, Gladsaxe Municipality, Denmark AGC Biologics Full time

    About 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...


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

    About the Role">We are seeking a highly skilled Quality Assurance Specialist to join our team at Novo Nordisk. This is an exciting opportunity for someone who is passionate about quality and safety in pharmaceutical manufacturing.">Job Summary">The successful candidate will be responsible for ensuring patient safety by delivering high-quality standards for...


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

    We 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 A/S in Bagsværd, Denmark.As a QA Professional, you will be responsible for ensuring compliance with regulatory requirements, quality standards, and company...


  • Gladsaxe, Gladsaxe Municipality, Denmark AGC Biologics Full time

    Job OverviewWe are seeking a highly motivated and experienced Quality Assurance Specialist to join our team in Copenhagen. As a key member of the Plant Engineering department, you will be responsible for ensuring compliance with quality-related tasks and procedures.About the RoleThis is a challenging and rewarding opportunity for a technical professional to...


  • Gladsaxe, Gladsaxe Municipality, Denmark AGC Biologics Full time

    Unlock a Career in Global Biopharmaceuticals">AGC Biologics, a leading Contract Development Manufacturing Organization (CDMO), invites highly motivated and experienced professionals to join our team as Quality Assurance Specialists. As a trusted partner for biotech companies worldwide, we provide comprehensive solutions for commercial and clinical cGMP...


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

    About the PositionAt Novo Nordisk, we are seeking a highly skilled Quality Assurance Specialist to join our team. As a key member of our Digital Health & Staffs Quality department, you will be responsible for ensuring the quality and compliance of our customer service processes.Your Key ResponsibilitiesProcess Design and Implementation: Provide QA input on...


  • Gladsaxe, Gladsaxe Municipality, Denmark AGC Biologics Full time

    Are you a motivated and experienced Quality Assurance professional looking for a new challenge? Do you have a strong background in quality management and a passion for ensuring compliance with regulatory requirements?We are seeking a highly skilled Quality Assurance Specialist to join our team at AGC Biologics. As a Quality Assurance Specialist, you will be...


  • Gladsaxe, Gladsaxe Municipality, Denmark AGC Biologics Full time

    At AGC Biologics, our mission is to bring hope to life by enabling life-changing therapies for patients worldwide. We strive to work collaboratively with our customers to improve patient lives through the development and delivery of innovative biopharmaceuticals.This exciting opportunity as a QA Scientist will see you join a diverse team of highly qualified...


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

    About the RoleWe are seeking a highly motivated and experienced Quality Assurance Professional to join our CMC API QA team at Novo Nordisk A/S. As a key member of our team, you will be responsible for ensuring compliance with regulatory requirements, quality standards, and company policies in the raw material and CMO shipping area.ResponsibilitiesDeliver...


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

    We are seeking a highly motivated and experienced Quality Assurance Professional to join our CMC API QA team at Novo Nordisk A/S, based in Bagsværd, Denmark.The successful candidate will serve as QP delegate, primarily responsible for releasing internal and externally produced Active Pharmaceutical Ingredients (API) for usage in the Novo Nordisk clinical...


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

    About the RoleWe are seeking a highly skilled Quality Assurance Specialist to join our team at Novo Nordisk A/S. As a key member of our QA unit, you will play a critical role in ensuring patient safety and delivering high-quality standards for our products and production processes.The successful candidate will have a strong background in quality assurance,...


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

    About the RoleWe are seeking a highly skilled Quality Assurance Expert to join our team at Novo Nordisk A/S. As a QA Specialist, you will play a crucial role in ensuring patient safety and delivering high-quality standards for our products and production processes.This is an exciting opportunity to work in a fast-paced environment with a strong focus on...


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

    About the Opportunity">We are seeking a highly motivated and experienced Quality Assurance Professional to join our CMC API QA team at Novo Nordisk A/S. As a member of this dynamic team, you will be responsible for ensuring compliance with regulatory requirements, quality standards, and company policies.Your Key ResponsibilitiesDeliver best-in-class quality...