Scientist, QA Manufacturing Support (maternity cover)

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 passionate about Quality and Quality Assurance (QA) Would you like to learn and grow in a QA Scientist function which supports our manufacturing operations Are you curious about how a CDMO operates and excited to build a solid GMP foundation

This is your chance of joining our QA Manufacturing Support team in a 9 months maternity cover! In this team you will get a broad exposure to our manufacturing organization and drive collaboration with internal stakeholders!The key responsibility of the team includes ensuring manufacturing compliance with applicable procedures providing real time review of manufacturing records and logbooks and working with Manufacturing Operations to resolve issues.

Your Key Responsibilities:

• Provide on the line Quality oversight/presence in the production area during manufacturing regarding on the line documents (i.e. MPRs) and product checks and quality support for production enquiries. To inform line management of any issues relating to the quality of products or materials.
• 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 (GDocP) related queries.
• Perform Quality review and approval of deviations (DEVs) change controls (CRs) and CAPAs.
• Perform Buffer and Media MPR review and approval.
• Perform Shipping/Prepacking approval.
• Manufacturing label management.
• Perform QA Line Approval to ensure that the production line is fully ready (i.e. cleaned and configured correctly).

More Related Tasks:

• 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.
• Participate in GEMBA walks of the production area and conduct specific site systems audits in accordance with the agreed schedule.
• Archiving.
• Review and approval of validation/ qualification documentation.
• Participate in Ad-hoc projects.
• Represent QA Manufacturing Support and participate as a Subject Matter Expert (SME) during audits/inspections.

Your Profile - Experience & Personal Characteristics:

The ideal candidate holds a Masters degree in Natural Sciences. It is not a requirement but an advantage if you have previous experience with Line Approvals QA Oversight or BPR/MPR review from a GMP aseptic manufacturing environment or Biopharma - or GMP knowledge in general. Besides your experience you could be the team member we are looking for if you recognize yourself amongst these personal characteristics:

• 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.

Recruitment Process - Application & Interviews:

Please note that this is a maternity cover of 9 months potentially with a possibility of extension. Please submit your CV as soon as possible and no later than January 6 2026. We expect to conduct first round interviews in week 3 and second round interviews in week 4 2026. We are looking forward to hearing from you!

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 2500 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.