Associate Principal Scientist, Quality Assurance
3 days ago
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 Quality Assurance of Material Management.
QA for Material Management is an important part of the Quality organization. You will be joining a diverse team of highly qualified colleagues, many with several years of experience within quality assurance.
This QA team is responsible for support of Supply Chain Management and QC in the areas for deviations, CAPA, change management, complaints, GMP documentation etc. in relation to material management. We also have oversight of the respective areas and assist with internal and external audits and regulatory inspections.
We are actively involved in the constant development within our field and the continuous improvement of our quality system. We aim at constantly ensuring that QC and manufacturing are in compliance with current standards for GMP production, i.e. EU GMP, 21 CFR and ICH guidelines.
The department has an open communication with focus on a high level of professionalism. We are open-minded and have a high support level to our colleagues in the rest of AGC Biologics A/S - and not least to our international customers. The QA Operations department is characterized by positive and proactive colleagues meeting deadlines through committed and friendly collaboration.
Tasks and ResponsibilitiesAs QA Scientist you will be involved in various daily operational tasks in a dynamic and challenging environment.
Your main responsibility will be to support Supply chain, Process Transfer and QC for late stage and commercial products, which includes:
- Close collaboration with internal stakeholders
- Change control, deviation handling and CAPAs
- Review and approval of material specifications
- Release of raw materials and disposables
We cooperate closely with the other departments in the organization in order to ensure that all quality related activities are carried out effectively and in compliance with cGMP.
Your ProfileYou have 3+ years of experience with Quality Assurance and/or material management. It is a requirement for this position to have a relevant academic background within pharmacy, biotechnology, biology, chemistry or similar.
You have experience within the following areas:
- Proven experience from QA and/or Material Management
- Requirements for commercial and/or late state clinical phase GMP manufacturing of biological intermediates, APIs and Cell Banks
- QA oversight and guidance of staff
- Experience with contract manufacturing and business understanding
- Deviation handling including root cause investigations
- Review and evaluation of cGMP documentation
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. AGC has international customers and our company language is English. It is therefore a required ability that communication in both written and spoken English is fluent.
AGC offersAGC offers a dynamic working place with good opportunities of working with a varied array of tasks and challenges. You will get insight into and experience with the way the various departments throughout a contract manufacturing organization interact in order to achieve success. Exciting and challenging assignments will constantly come your way, and you will to a large extent be able to plan your daily work yourself. AGC offers an informal working environment, where humor is part of the daily work life. We respect each other and our individual differences. AGC’s employees have a flexible attitude and we help each other to reach deadlines together as one team.
ContactPlease send all applications via our career site. We will process the applications as they arrive. Therefore, please submit your application and CV as soon as possible. The job ad will close once we have found the right candidate.
AGC Biologics (AGC) is a global Contract Development Manufacturing Organization (CDMO) with bio-manufacturing facilities in Europe, Japan, Italy and the USA. The company provides a comprehensive range of commercial and clinical cGMP biologics manufacturing services, from DNA to active pharmaceutical ingredient (API). The company’s team and approach are tailored to each of its client’s needs, whether turnkey manufacturing or sophisticated, stand-alone analytical, formulation and stability services. Visit to learn why AGC Biologics is a World Leader in process development and contract manufacturing.
Location: Copenhagen Site
#J-18808-Ljbffr-
Gladsaxe, Gladsaxe Municipality, Denmark Novo Nordisk AS Full timeAbout the RoleWe are seeking a highly experienced and motivated Principal Quality Assurance Professional to join our CMC API QA team at Novo Nordisk A/S.The successful candidate will serve as QP delegate, primarily responsible for releasing internal and externally produced Active Pharmaceutical Ingredients (API) for usage in clinical trials. Key...
-
Senior Scientist, Quality Assurance
3 days ago
Gladsaxe Kommune, Denmark AGC Biologics Full timeOur 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...
-
Scientist, Quality Control
3 days ago
Gladsaxe Kommune, Denmark AGC Biologics Full timeThe 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...
-
Senior/Principal Scientist, Quality Control
3 days ago
Gladsaxe Kommune, Denmark AGC Biologics Full timeJoin a dynamic and international company where everyone is responsible for delivering right on time as one team! The Position By joining the QC Raw Material team, you will be key in implementing new raw materials to support new phase I/II projects as well as planning the Raw Material Qualification and Release Testing program for late stage projects. As part...
-
Temporary Scientist, Quality Control
3 days ago
Gladsaxe Kommune, Denmark AGC Biologics Full timeThis is a one year temporary QC Scientist 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...
-
Senior Quality Assurance Analyst
3 days ago
Gentofte Kommune, Denmark Saxo Bank AS Full timeCopenhagen, Denmark About the job We are looking to expand our AML Quality Team at our headquarters in Copenhagen. The team is currently undergoing a transformation, focusing on quality assurance of Nordic and institutional clients to elevate and monitor the AML quality of Saxo Bank. As our new Quality Assurance Analyst or Senior Analyst, you will be...
-
Senior Quality Assurance Specialist
2 days ago
Gladsaxe, Gladsaxe Municipality, Denmark Novo Nordisk AS Full timeQuality Assurance Professional OpportunityWe are seeking a highly motivated and experienced Quality Assurance Professional to join our Chemistry, Manufacturing and Control (CMC) Active Pharmaceutical Ingredients (API) QA team.The successful candidate will support CMC API Development within the raw material and CMO shipping area. You will be responsible for...
-
Biologics Quality Assurance Specialist
18 minutes ago
Gladsaxe, Gladsaxe Municipality, Denmark AGC Biologics Full timeAbout the RoleWe are seeking an experienced Biologics Quality Assurance Specialist to join our QMS & Training team in the Quality Systems department. As a key member of our team, you will collaborate with partners and drive improvement projects optimizing our GMP Training standards and systems.Your primary responsibility will be to develop new training...
-
Senior Scientist Biopharmaceutical Quality Control
19 minutes ago
Gladsaxe, Gladsaxe Municipality, Denmark AGC Biologics Full timeAGC Biologics is a global Contract Development and Manufacturing Organization (CDMO) dedicated to bringing hope to life by enabling life-changing therapies for patients around the globe. We create a healthier and happier tomorrow through our work side by side with customers to improve patients' lives by bringing new biopharmaceuticals to market.We develop...
-
Scientist, Quality Systems
3 days ago
Gladsaxe Kommune, Denmark AGC Biologics Full timeOur 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 experienced in GMP training? Our QMS & Training team in Quality...
-
Gladsaxe, Gladsaxe Municipality, Denmark AGC Biologics Full timeJob OverviewWe are seeking an experienced Senior Quality Assurance Specialist to support our biologics manufacturing operations.Key ResponsibilitiesCollaborate closely with internal stakeholders to ensure effective quality management.Support Supply Chain, Process Transfer, and QC for late stage and commercial products.Review and approve material...
-
Medical Device Quality Assurance Specialist
19 minutes ago
Gladsaxe, Gladsaxe Municipality, Denmark FERROSAN MEDICAL DEVICES AS Full timeJob DescriptionFerrosan Medical Devices A/S is a leading provider of medical devices used in surgical care. We are seeking an experienced Medical Device Quality Assurance Specialist to join our team.About the RoleThe successful candidate will be responsible for ensuring the highest quality of our medical devices, working closely with various teams to ensure...
-
Leaders to Associate Manager Pipeline
3 days ago
Gladsaxe Kommune, Denmark Novo Nordisk AS Full timeJobbeskrivelse Placering Søborg, Denmark Jobkategori Manufacturing Ansøg nu Are you ready to take the next step and pursue a life-changing career at Novo Nordisk? We have opportunities at all levels making it possible to challenge you and put your skills into play. Joining the Associate Manager Pipeline By applying for the pipeline, you will be...
-
Leaders to Associate Manager Pipeline
3 days ago
Gladsaxe Kommune, Denmark Novo Nordisk AS Full timeJobbeskrivelse Placering Bagsværd, Denmark Jobkategori Manufacturing Ansøg nu Are you ready to take the next step and pursue a life-changing career at Novo Nordisk? We have opportunities at all levels making it possible to challenge you and put your skills into play. Joining the Associate Manager Pipeline By applying for the pipeline, you will be...
-
Gladsaxe, Gladsaxe Municipality, Denmark Novo Nordisk AS Full timeAbout the RoleAs a Customer Service QA Professional at Novo Nordisk A/S, you will be responsible for ensuring that our customer service processes are of the highest quality and compliant with regulatory requirements. This is an exciting opportunity to join a dynamic team that is passionate about delivering excellent customer experiences.Key...
-
Senior Scientist, Quality Control
3 days ago
Gladsaxe Kommune, Denmark AGC Biologics Full timeOur 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 motivated by leading and participating in coordination and...
-
Gladsaxe, Gladsaxe Municipality, Denmark Novo Nordisk AS Full timeAbout Novo Nordisk A/S">We strive for excellence in all our endeavors, consistently pushing the boundaries of innovation to improve the quality of life for patients worldwide. As a global leader in diabetes care and biopharmaceuticals, we understand the importance of quality in every aspect of our operations.">The Role">As a Quality Assurance Expert for...
-
QC Bioassay Senior Scientist
3 days ago
Gladsaxe Kommune, Denmark AGC Biologics Full timeOur 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...
-
Scientist, QA Manufacturing Support
3 days ago
Gladsaxe Kommune, Denmark AGC Biologics Full timeOur 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...
-
Global Senior Quality Assurance Manager
3 days ago
Aarhus kommune, Denmark Arla Foods Deutschland GmbH Full timeGlobal Senior Quality Assurance Manager - Viby Location: Viby J, DK Are you interested in joining and leading an exceptional team that supports the organization with Quality Assurance? Are you passionate about establishing positive interactions and creating a valuable impact? If so, you could be the colleague we are looking for. Arla Foods Ingredients (AFI)...
