Scientist, QA Manufacturing Support

3 months ago

København, Denmark AGC Inc Full time
Scientist, QA Manufacturing Support

Apply locations: Copenhagen, Denmark

Time type: Full time

Posted on: Posted 29 Days Ago

Job requisition id: JR100828

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. 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 the 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.

We will process the applications as they arrive. Therefore, please submit your application and CV as soon as possible.

Our culture at AGC Biologics is defined by the six core values: Knowledge, Trust, Quality, Ingenuity, Accountability and Teamwork. Our core values stem from our team members and are embedded into our DNA. They provide a common language and understanding of how we as an organization are connected across three continents. Our core values serve as a compass and reminder of how we achieve our purpose of bringing hope to life for patients around the globe.

AGC Biologics is a leading global biopharmaceutical Contract Development and Manufacturing Organization (CDMO) with a strong commitment to delivering the highest standard of service as we work side-by-side with our clients and partners, every step of the way. We provide world-class development and manufacture of mammalian and microbial-based therapeutic proteins, plasmid DNA (pDNA), messenger RNA (mRNA), viral vectors, and genetically engineered cells. Our global network spans the U.S., Europe, and Asia, with cGMP-compliant facilities in Seattle, Washington; Boulder and Longmont, Colorado; Copenhagen, Denmark; Heidelberg, Germany; Milan, Italy; and Chiba, Japan. We currently employ more than 2,500 employees worldwide. Our commitment to continuous innovation fosters the technical creativity to solve our clients’ most complex challenges, including specialization in fast-track projects and rare diseases. AGC Biologics is the partner of choice. To learn more, visit

Want to keep posted about our growth and learn more about our company? Follow us on LinkedIn and give us a quick Like on Facebook

AGC Biologics offers a highly competitive compensation package and a friendly, collaborative culture that values personal initiative and professional achievement. AGC Biologics is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to age, ancestry, color, family or medical care leave, gender identity or expression, genetic information, marital status, medical condition, national origin, physical or mental disability, political affiliation, protected veteran status, race, religion, sexual orientation, or any other characteristic protected by applicable laws, regulations and ordinances.

#J-18808-Ljbffr

  • Manufacturing QA Engineer

    1 month ago

    København, Denmark Agilent Technologies, Inc. Full time

    Manufacturing QA Engineer We are looking for a new team member. Join us! Agilent inspires and supports discoveries that advance the quality of life. We provide life science, diagnostic and applied market laboratories worldwide with instruments, services, consumables, applications, and expertise. Agilent enables customers to gain the answers and insights they...

  • Senior Scientist, Quality Assurance

    1 month ago

    København, Denmark AGC Inc Full time

    Senior Scientist, Quality Assurance 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...

  • QA & Support Specialist

    3 months ago

    København, Denmark Teton.ai Aps Full time

    Quality Assurance Full-time Copenhagen, DK Teton is building AI technology that empowers nurses and frontline care staff to deliver more effective care with less stress. Our solution helps hospitals and care homes maintain critical care standards and patient safety, addressing the global nursing shortage with innovative AI tools. At Teton, we operate...

  • Full stack Developer/QA Engineer

    3 months ago

    København, Denmark ReFlow Full time

    ReFlow Remote Work Freelance Salary Competitive Are you passionate about sustainability and eager to apply your technical skills to make a real impact? ReFlow, a leading environmental engineering firm, seeks a motivated and talented Sustainability Data Scientist to join our team for the summer of 2024. At ReFlow, we specialize in lifecycle assessment (LCA)...

  • Senior Upstream Scientist

    2 weeks ago

    København, Denmark Blackswansexist Full time

    Job Description: Senior Upstream Scientist – MSAT Position Summary We are seeking a skilled Senior Upstream Scientist to join our Process Science / Manufacturing Science and Technology (MSAT) team. In this critical role, you will act as a subject matter expert in cell culture processes, ensuring the successful introduction, transfer, and implementation...

  • Scientist, Senior/Principal Scientist, Quality Control

    1 month ago

    København, Denmark AGC Inc Full time

    Scientist, Senior/Principal Scientist, Quality Control Apply Location: Copenhagen, Denmark Time Type: Full time Posted on: Posted 17 Days Ago Job Requisition ID: JR101009 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...

  • Manager, QA GMP

    3 months ago

    København, Denmark Genmab Full time

    At Genmab, we’re committed to building extraordinary futures together, by developing antibody products and pioneering therapies that change the lives of patients and the future of cancer treatment and serious diseases. From our people who are caring, candid, and impact-driven to our business, which is innovative and rooted in science, we believe that being...

  • Senior QC Scientist

    3 months ago

    København, Denmark H. Lundbeck AS Full time

    Senior Quality Control Scientist, QC CMC Biologics Do you want to join our international CMC Biologics Quality Control team? And are you eager to work in an international setting where empowerment and cross functional collaboration skills are key? Then you might be our new Senior Quality Control Scientist! Your new role – why is this a great opportunity? ...

  • QA Lean Partner

    3 months ago

    København, Denmark AJ Vaccines Full time

    We are offering a unique opportunity for an innovative QA LEAN Partner to establish and develop a new role within our Quality Assurance department. In this position, you will have the freedom to shape and define this role from the ground up, working closely with senior leadership to influence the direction of quality assurance processes. Reporting directly...

  • QA/QC Manager

    2 months ago

    København, Denmark Blackswansexist Full time

    What if your job was about ensuring the consistent delivery of high-quality products that make a positive impact on the world? Our client has built strong foundations, and now they are looking for someone passionate about maintaining and optimizing our quality standards. If you thrive in a dynamic biotech environment, where no two days are the same, and...

  • Senior Scientist, Late Stage Upstream Process Development

    2 weeks ago

    København, Denmark AGC Inc Full time

    Senior Scientist, Late Stage Upstream Process Development Apply locations: Copenhagen, DenmarkTime type: Full timePosted on: Posted 25 Days AgoTime left to apply: End Date: December 8, 2024 (3 days left to apply)Job requisition id: JR101067 Our purpose is to bring hope to life by enabling life-changing therapies for patients around the globe, creating a...

  • Senior QA Engineer

    3 months ago

    København, Denmark Shape Aps Full time

    BECOME A PART OF THE TEAM Shape is an award-winning app-focused digital product studio based in Copenhagen, Denmark. We’re dedicated to making outstanding apps for prominent clients such as OK, PureGym, Nordisk Film, Bolius, TV2 Regions, Solar, Magasin, RedBull, Mofibo, and Aarstiderne. We are proud that our work is touched, tapped, swiped, and pinched by...

  • Senior QA Engineer

    3 months ago

    København, Denmark The HubDanske Bank Full time

    BECOME A PART OF THE TEAM Shape is an award-winning app-focused digital product studio based in Copenhagen, Denmark. We’re dedicated to making outstanding apps for prominent clients such as OK, PureGym, Nordisk Film, Bolius, TV2 Regions, Solar, Magasin, RedBull, Mofibo, and Aarstiderne. We are proud that our work is touched, tapped, swiped, and pinched by...

  • Senior QA

    3 months ago

    København, Denmark Banking Circle Full time

    Are you competent in improving quality, automate processes and thrive working in an agile environment? Do you value using your technical understanding to create the best possible testing of our solutions, in a team where we want to collaborate on testing early in the development cycle and support frequent deployments and releases to Cloud? Banking Circle is...

  • Data Scientist

    1 month ago

    København, Denmark Acceleration WPP Group Full time

    Join a growing team of Data Scientists transforming marketing for some of the world's largest brands! Join a team of expert Data Scientists and Consultants at Choreograph, a GroupM company, revolutionizing marketing for the world's biggest brands. We transform data into powerful solutions for complex media and marketing challenges, leveraging cutting-edge...

  • Data Scientist

    1 month ago

    København, Denmark Acceleration WPP Group Full time

    Join a growing team of Data Scientists transforming marketing for some of the world's largest brands! Join a team of expert Data Scientists and Consultants at Choreograph, a GroupM company, revolutionizing marketing for the world's biggest brands. We transform data into powerful solutions for complex media and marketing challenges, leveraging cutting-edge...

  • Medical device QA/RA Consultant

    3 months ago

    København, Denmark The HubDanske Bank Full time

    This is a temporary consultancy position to support while we search for a permanent hire Do you have a flair for product quality? And are you curious to see if you can put your QA/RA experience to work and place our products in new markets? Maybe you have been working with product registrations for a while and now you would like to work more holistically...

  • Senior Data Scientist

    2 weeks ago

    København, Denmark Carlsberg Group Full time

    Location: Copenhagen, DK Entity / company: Integrated Information Technology (IIT) Senior Data Scientist We are seeking a skilled data scientist to define Carlsberg's data science strategy and lead the creation of advanced analytics and machine learning models to address intricate business challenges at Carlsberg. Great beers, great colleagues, a focus on...

  • Medical device QA/RA Consultant

    3 months ago

    København, Denmark Radiobotics ApS Full time

    Radiobotics Copenhagen Freelance Part-time Salary Competitive This is a temporary consultancy position to support while we search for a permanent hire Do you have a flair for product quality? And are you curious to see if you can put your QA/RA experience to work and place our products in new markets? Maybe you have been working with product registrations...

  • Research Scientist

    1 week ago

    København, Denmark Novozymes AS, part of Novonesis Group Full time

    time left to apply End Date: January 6, 2025 (24 days left to apply) job requisition id JR103862 Are you ready for a new beginning? We need your talent, knowledge and dedication to better our world with biology. Our purpose points the way In Novonesis, we know that solutions rooted in biology can help solve humanity’s biggest challenges. Since we began...