Scientist, QA Mammalian; maternity cover

Scientist, QA Mammalian (maternity cover) page is loaded## Scientist, QA Mammalian (maternity cover) locations:
Copenhagen, Denmark time type:
Full time posted on:
Posted 5 Days Agotime left to apply:
End Date:
January 14, 2026 (15 days left to apply) job requisition :
JR102591
** 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 Department:
** QA Operations consists of two sub teams with the main responsibility of quality assurance of manufacturing activities and batch release of mammalian recombinant manufacturing of drug substances (API) and cellbanks. AGC Biologics is a CDMO and covering international pharma customers. We manufacture a big range of drug substances from clinical to commercial. The two sub teams are scientists and senior scientists with various professional backgrounds and years of experience.

The department has an open communication with a focus on a high level of professionalism. We are open-minded and have a high service level for our colleagues in the rest of the AGC Biologics organization - and not least for our international customers. The QA Operations team is characterized by positive and proactive colleagues meeting deadlines through committed and friendly collaboration.

We actively work within our field of understanding- and interpreting legislation to ensure manufacturing is in compliance with current standards for GMP production, i.e., EU GMP, 21 CFR and ICH guidelines. Continuously we improve our standards within quality- and manufacturing processes, innovate with modern technology and our common value chain with internal stakeholders.
** Role & Responsibilities:
** The QA Scientist provides customer service, with the highest integrity, focused on quality and compliance with partnership with AGC Biologics. You will help ensuring resolution of significant quality issues with the client through coordination and collaboration of internal functional resources to identify, proposing and carrying out an efficient plan to settle the issue, while protecting product quality and patient’s safety.

You will be responsible for the overall QA review and approval of all technical documents including but not limited to:
* Batch production records (BPR).
* Change controls
* Deviations* CAPAs
* DS specifications
* Master Production Records
* Risk Assessments
* Support the generation of new, as well as improvement of, existing department SOPs
* Support delivery of AGC projects
* Work with management to resolve project issues and resource constraints within the team
* Support client audits as necessary
* Assist with negotiation terms of Quality agreements with the client as required
* Liaise with the internal and external stakeholders to resolve and clarify any point of issue
* Assist with the generation of APQR (Annual Product Quality Review)
** Your Profile**:

We are looking for a colleague with relevant educational background and GMP experience:
* You have 2 years of experience with Quality Assurance or 5 years relevant GMP experience.
* A science-based Master’s degree or equivalent.
* Substantial experience working in or directly supporting manufacturing within a drug substance/product manufacturing site.
* Previous biopharma experience is preferred.
* Strong working knowledge of the principles and guidelines for GMP.It is of utmost importance to have a self-motivating personality with a pragmatic attitude and approach to the daily work - without compromising quality. The environment is dynamic and challenging, which requires the ability to find solutions, deliver on promises and give our customers a positive experience. Other personal characteristics relevant to this role are:
* Strong decision making and ‘can do’ attitude.
* Excellent written and verbal communication skills in English to internal and external stakeholders.
* Ability to work in a fast paced, matrix environment essential.
* Capable of working to deadlines and prioritizing multiple tasks.
* Flexibility…