Scientist, QA Manufacturing Support

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.
• 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 www.agcbio.com. 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.

Location: Copenhagen Site