Scientist, QA Manufacturing Support

3 months ago


Gladsaxe Kommune, Denmark AGC Biologics Full time

Our purpose is to bring hope to life by enabling life-changing therapies for patients around the globe, creating a healthier and happier tomorrow. Our mission is to work side by side with our customers in order to improve patients’ lives by bringing new biopharmaceuticals to market.

The QA Manufacturing Support Scientist is responsible for quality activities supporting Manufacturing Operations in accordance with procedures and GMP requirements. Functional responsibilities include ensuring manufacturing compliance with applicable procedures, providing real-time review of manufacturing records and logbooks, and working with Manufacturing Operations to resolve issues.

Primary Role (daily responsibilities):

  • Provide an “on-line” Quality presence in the production area during manufacture regarding on the line documents and product checks and quality support for production enquiries. To inform line management of any issues relating to the quality of products or materials.
  • Perform QA sign off after set-up to confirm that the manufacturing line has been set up as per requirements in batch documentation and associated SOPs.
  • Conduct batch record “Stage Approval” as part of batch release process.
  • Participate in Gemba walks of the production area and conduct specific site systems audits in accordance with the agreed schedule.
  • Shipping/ prepacking approval.
  • Manufacturing label management.
  • Archiving.
  • Review and approval of validation/ qualification documentation.
  • Review all batch documentation, liaising with production management to resolve and clarify any points of issue.
  • Work with manufacturing to drive improvements in GMP compliance across all shifts.
  • Support manufacturing during batch review with Good Documentation Practice related queries.
  • Perform Quality review and approval of deviations (DEVs), change controls (CRs) and CAPAs.
  • Buffer and media MPR review and approval.

Education and Experience:

  • Bachelor's and/or Master’s degree in Natural Sciences.
  • Alternatively, certified laboratory technician with a degree in laboratory science, biotechnology, medical laboratory technology including 3-5 years experience within a GMP environment in the Pharma Industry.
  • Experience with BPR/MPR review will be a plus.
  • Previous biopharma experience is preferred but not a requirement.
  • Strong working knowledge of the principles and guidelines for GMP is a plus.
  • Strong decision maker and ‘can do’ attitude.
  • Excellent written and verbal communication skills to internal and external stakeholders.
  • Ability to work in a fast-paced, matrix environment is essential.
  • Capable of working to deadlines and prioritizing multiple tasks.
  • Flexibility to meet changing needs and priorities of the business.
  • Experience working in a GMP aseptic manufacturing environment will be a plus.

Location: Copenhagen Site

#J-18808-Ljbffr

  • Gladsaxe Kommune, Denmark AGC Biologics Full time

    Our purpose is to bring hope to life by enabling life-changing therapies for patients around the globe, creating a healthier and happier tomorrow. Our mission is to work side by side with our customers in order to improve patients’ lives by bringing new biopharmaceuticals to market. Do you have experience working in a cGMP environment and are you looking...


  • Gladsaxe, Gladsaxe Municipality, Denmark AGC Biologics Full time

    Job OverviewThis role is an exciting opportunity to join the manufacturing team at AGC Biologics as a Scientist in the Commercial Microbial department.About the RoleWe are seeking a highly skilled and experienced scientist with expertise in process support to join our team. As a key member of the production team, you will be responsible for ensuring smooth...


  • Gladsaxe Kommune, Denmark AGC Biologics Full time

    As a CDMO, AGC Biologics manufactures drugs for a variety of different customers. Depending on the customer needs, this can be drugs ranging from development, to clinical and commercial production. Right now, you have the opportunity to join the Manufacturing Product Support department as we have several open positions across the department within upstream,...


  • Gladsaxe, Gladsaxe Municipality, Denmark AGC Biologics Full time

    AGC Biologics A/S is a leading global Contract Development and Manufacturing Organization (CDMO) dedicated to bringing life-changing therapies to patients worldwide. Our mission is to support the development of innovative biopharmaceuticals by providing cutting-edge manufacturing solutions.The position of Senior Scientist is available in our QC Bioassay...


  • Gladsaxe Kommune, Denmark AGC Biologics Full time

    Our purpose is to bring hope to life by enabling life-changing therapies for patients around the globe, creating a healthier and happier tomorrow. Our mission is to work side by side with our customers in order to improve patients’ lives by bringing new biopharmaceuticals to market. Are you looking for an exciting job in a fast-growing international CDMO...


  • Gladsaxe Kommune, Denmark AGC Biologics Full time

    Our purpose is to bring hope to life by enabling life-changing therapies for patients around the globe, creating a healthier and happier tomorrow. Our mission is to work side by side with our customers in order to improve patients’ lives by bringing new biopharmaceuticals to market. AGC Biologics is looking for an experienced QA scientist to assist with...


  • Gladsaxe, Gladsaxe Municipality, Denmark AGC Biologics Full time

    Unlock Career Growth OpportunitiesWe are seeking a skilled Scientist, Manufacturing Operations Specialist to join our team at AGC Biologics in Copenhagen. This exciting role offers the chance to work with cutting-edge technologies and collaborate with diverse nationalities.About the RoleAs a Scientist, Manufacturing Operations Specialist, you will be...


  • Gladsaxe, Gladsaxe Municipality, Denmark AGC Biologics Full time

    About the RoleWe are seeking a talented Scientist to join our Manufacturing Product Support department at AGC Biologics. This is an exciting opportunity for a skilled professional to contribute to the production process of buffers and media for commercial production.The ideal candidate will have experience working in a cGMP environment and be proficient in...


  • Gladsaxe Kommune, Denmark AGC Biologics Full time

    Our purpose is to bring hope to life by enabling life-changing therapies for patients around the globe, creating a healthier and happier tomorrow. Our mission is to work side by side with our customers in order to improve patients’ lives by bringing new biopharmaceuticals to market. Would you like to be a part of AGC Biologics' growing success? We are...


  • 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 AGC Biologics Full time

    About AGC BiologicsWe are a global Contract Development and Manufacturing Organization (CDMO) dedicated to enabling life-changing therapies for patients around the globe.Our mission is to work closely with customers to bring new biopharmaceuticals to market, improving patients' lives through innovative manufacturing processes and GMP compliance.The RoleWe...


  • Gladsaxe Kommune, Denmark AGC Biologics Full time

    Our purpose is to bring hope to life by enabling life-changing therapies for patients around the globe, creating a healthier and happier tomorrow. Our mission is to work side by side with our customers in order to improve patients’ lives by bringing new biopharmaceuticals to market. AGC is looking for a Scientist / Sen. Scientist with expertise and...


  • 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 Kommune, Denmark AGC Biologics Full time

    The Position You will be a part of the QC Stability Team which is a part of Quality Control handling stability studies of Drug Substance, Drug Product, Placebo, and Reference Material. Your working day is characterized by ongoing collaborations with stakeholders such as customers, project managers, management, your own department, and QA. Along with your...


  • 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...

  • Senior Scientist

    2 months ago


    Gladsaxe, Gladsaxe Municipality, Denmark AGC Biologics Full time

    Delivering Hope Through Biopharmaceutical TestingAbout the Role:We are seeking a highly skilled Senior Scientist to join our QC Bioassay team at AGC Biologics. As a key member of our team, you will be responsible for ensuring the timely release and stability testing of biopharmaceutical products for our customers. This involves reviewing and approving...

  • QA Specialist

    3 months ago


    Gladsaxe Kommune, Denmark Novo Nordisk AS Full time

    Jobbeskrivelse Placering Bagsværd, Denmark Jobkategori Quality Ansøg nu We are looking for a skilled QA specialist, to take part in a strong, evolving, and fast-moving organisation with a significant role in securing the quality and safety of Novo Nordisk's products. Does this sound like a job for you? Then you may be the person we are looking for to...


  • 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

    Unlock a Career in BiopharmaceuticalsAGC Biologics is seeking an experienced Biological Medicines Scientist to join our dynamic team. As a Senior Scientist, you will be responsible for ensuring the timely release and stability testing of biopharmaceutical products.About the RoleReview and approval of analytical results from various bioassay methods,...


  • 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...