Quality Control Specialist for Raw Materials

4 weeks ago


Gladsaxe, Gladsaxe Municipality, Denmark AGC Biologics Full time

About AGC Biologics

We strive to bring hope to life by enabling life-changing therapies for patients worldwide, creating a healthier and happier tomorrow.

Our mission is to collaborate closely with our customers to improve patients' lives by introducing new biopharmaceuticals to the market.

The Position

You will be part of the QC Raw Materials Team within QC Support, working alongside experienced scientists and technicians.

Your daily tasks will involve a mix of sampling Raw Materials, laboratory work, and analysis. You can expect ongoing collaboration with QC Raw Materials scientists and technicians.

Key Responsibilities

  • Prepare and perform sampling of Raw Materials
  • Handle sample shipments
  • Engage with internal and external stakeholders
  • Analyze Raw materials using Near-Infrared (NIR) and visual inspection
  • E nsure compliance with Good Manufacturing Practice (GMP) and relevant Standard Operating Procedures (SOP)

About the Department

You will join the QC Raw Materials team within QC Support, consisting of three departments: QC Raw Materials, QC Samples & Service, and QC Stability.

QC Stability comprises six scientists and four technicians.

Requirements

  • Bachelor's degree in Laboratory Technology or a related field
  • Prior experience in quality control, preferably in a GMP laboratory
  • Familiarity with sampling and material handling
  • Knowledge of Near-Infrared (NIR) spectroscopy
  • Excellent communication skills in English
  • Able to work independently and collaboratively as part of a team

We offer a competitive salary, estimated at around 65,000 USD per annum, based on the location and industry standards.



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

    Job DescriptionWe are seeking a highly skilled Raw Material Qualification Specialist to join our team in CMC API Process Operations at Novo Nordisk A/S. As a key member of our team, you will be responsible for ensuring the suitability of materials for GMP production to clinical trials from the entire Novo Nordisk development portfolio. Your expertise will be...


  • Gladsaxe, Gladsaxe Municipality, Denmark AGC Biologics Full time

    Job Overview:A Senior Raw Materials Manager is sought to lead our Material Science Team within the MSAT department at AGC Biologics in Copenhagen. This role will be responsible for overseeing and supporting the introduction of new raw materials, maintaining GMP documentation, ensuring regulatory compliance, and providing strategic input on raw...


  • Gladsaxe, Gladsaxe Municipality, Denmark AGC Biologics Full time

    Job DescriptionThis is a dynamic role that involves implementing new raw materials for phase I/II projects, planning the Raw Material Qualification and Release Testing program, and ensuring compliance with regulatory guidelines.ResponsibilitiesDevelop and review raw material specifications based on European or US regulatory guidelines.Create scientifically...


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

    About the PositionAs a key member of our CMC API Process Operations team, you will play a vital role in ensuring the suitability of materials for GMP production to clinical trials from our entire development portfolio. This includes cell therapy products, where your expertise will be crucial in setting internal release specifications for warehouse and...


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

    Job DescriptionThis is a senior leadership position responsible for leading a team of supply managers and quality professionals within the raw material category at Novo Nordisk A/S.The successful candidate will be accountable for building and optimizing the company's supply chain for all raw materials, engaging and optimizing supplier performance, and...


  • 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 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

    Key ResponsibilitiesAuthor and review raw material specifications based on European or US regulatory guidelines.Deliver scientifically sound and cGMP compliant raw material documents and analytical results.Involvement in operating the raw material program, including risk assessments and creating qualification protocol/reports.Oversight of sampling, as well...


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

    About the RoleWe are seeking a highly skilled Strategic Procurement Leader to join our team at Novo Nordisk A/S in Bagsværd, Denmark. As a key member of our Bioprocessing & Raw Materials (BPRM) department, you will play a critical role in driving strategic sourcing and supplier management initiatives that support our business objectives.The successful...


  • Gladsaxe, Gladsaxe Municipality, Denmark AGC Biologics Full time

    Job SummaryAGC 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 ResponsibilitiesClose collaboration with internal stakeholdersChange control, deviation handling, and CAPAsReview and...


  • Gladsaxe, Gladsaxe Municipality, Denmark AGC Biologics Full time

    About the JobWe are seeking a highly skilled Material Science Team Lead/Manager to join our team at AGC Biologics in Copenhagen. As a key member of our Process Transfer Department, you will be responsible for leading our Material Science Team and ensuring the introduction of new raw materials and single-use systems into our GMP manufacturing environment.Key...


  • Gladsaxe, Gladsaxe Municipality, Denmark AGC Biologics Full time

    We are seeking a Senior Material Scientist Team Lead to join our Process Transfer Department in Copenhagen. This role offers an exciting opportunity to lead and support the growth of our Material Science Team, while ensuring regulatory compliance and providing strategic input on raw material-related matters.About the JobThe Senior Material Scientist Team...


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

    About the RoleWe are seeking a highly motivated 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 ResponsibilitiesDeliver best-in-class quality assurance of raw materials and CMO shipping area to our drug substance and...


  • Gladsaxe, Gladsaxe Municipality, Denmark AGC Biologics Full time

    Job SummaryWe are seeking an experienced Biologics Manufacturing Expert in Quality Assurance to join our team at AGC Biologics. This role will be responsible for supporting Supply Chain, Process Transfer, and QC for late-stage and commercial products.Key ResponsibilitiesClose collaboration with internal stakeholders to ensure effective quality-related...


  • Gladsaxe, Gladsaxe Municipality, Denmark AGC Biologics Full time

    About the RoleAGC Biologics is seeking a dynamic and experienced professional to lead our Material Science team within the Process Transfer Department in Copenhagen. As a Team Lead/Manager, you will be responsible for overseeing the introduction of new raw materials and single-use systems (SUS), ensuring regulatory compliance, and providing strategic input...


  • 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 AGC Biologics Full time

    About the Position:We are seeking a highly motivated QA Specialist to join our Quality Assurance team at AGC Biologics. This role is responsible for ensuring compliance with current Good Manufacturing Practice (GMP) standards, including EU GMP, 21 CFR, and ICH guidelines.Key Responsibilities:Oversee the Quality Assurance review and approval of technical...


  • 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...


  • Gladsaxe, Gladsaxe Municipality, Denmark AGC Biologics Full time

    Discover a challenging and rewarding opportunity as a Senior Scientist in Quality Control at AGC Biologics. Our purpose is to bring hope to life by enabling life-changing therapies for patients worldwide. With a strong focus on analytical testing and method validation, you will play a key role in supporting the production of new or marketed...


  • 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...