Scientist, QA Manufacturing Support Specialist
4 weeks ago
Our mission is to work side by side with our customers to improve patients' lives by bringing new biopharmaceuticals to market.
The QA Manufacturing Support Scientist plays a crucial role in ensuring manufacturing compliance with applicable procedures and GMP requirements.
Key Responsibilities:
- Provide real-time quality support to manufacturing operations, ensuring adherence to procedures and GMP requirements.
- Review and approve manufacturing records and logbooks, identifying and resolving any issues.
- Collaborate with manufacturing operations to drive improvements in GMP compliance across all shifts.
- Support manufacturing during batch review, ensuring Good Documentation Practice.
- Perform quality review and approval of deviations, change controls, and CAPAs.
- Review and approve buffer and media MPRs.
Requirements:
- Bachelor's and/or Master's degree in Natural Sciences.
- Alternatively, certified laboratory technician with a degree in laboratory science, biotechnology, or medical laboratory technology, with 3-5 years of experience in a GMP environment.
- Experience with BPR/MPR review is a plus.
- Strong working knowledge of GMP principles and guidelines.
- Excellent written and verbal communication skills.
- Ability to work in a fast-paced, matrix environment.
Location: Copenhagen Site
-
Scientist, QA Manufacturing Support Specialist
3 weeks ago
Gladsaxe, Gladsaxe Municipality, Denmark AGC Biologics Full timeTransforming Lives through Quality ExcellenceAt AGC Biologics, we are committed to delivering life-changing therapies to patients worldwide. As a QA Manufacturing Support Scientist, you will play a vital role in ensuring the quality and compliance of our manufacturing operations.Key Responsibilities:Provide real-time quality support to manufacturing teams,...
-
Scientist, Manufacturing Specialist
3 weeks ago
Gladsaxe, Gladsaxe Municipality, Denmark AGC Biologics Full timeAt AGC Biologics, we're committed to delivering high-quality biopharmaceuticals to patients around the globe. As a Scientist, Manufacturing Specialist, you'll play a critical role in ensuring the success of our manufacturing processes. Key Responsibilities: Develop and implement manufacturing processes to meet customer requirements.Collaborate with...
-
Senior Scientist, Quality Assurance Specialist
1 month ago
Gladsaxe, Gladsaxe Municipality, Denmark AGC Biologics Full timeAbout the Role: We are seeking a highly motivated and experienced QA Scientist to join our team at AGC Biologics. As a QA Scientist, you will play a vital role in ensuring the quality and compliance of our manufacturing processes and facilities.Key Responsibilities: As a QA Scientist, your primary responsibilities will include:Reviewing and approving...
-
Scientist, Manufacturing
1 month ago
Gladsaxe, Gladsaxe Municipality, Denmark AGC Biologics Full timeTransforming Lives through Innovative ManufacturingAt AGC Biologics, we're dedicated to bringing hope to life by enabling life-changing therapies for patients worldwide. As a Scientist, Manufacturing, you'll play a vital role in our mission to create a healthier and happier tomorrow.About the RoleWe're seeking a highly skilled and motivated individual to...
-
Scientist, Manufacturing Specialist
5 days ago
Gladsaxe, Gladsaxe Municipality, Denmark AGC Biologics Full timeAbout the RoleWe are seeking a talented Scientist to join our Manufacturing Product Support department at AGC Biologics. This is an exciting opportunity for a skilled professional to contribute to the production process of buffers and media for commercial production.The ideal candidate will have experience working in a cGMP environment and be proficient in...
-
Gladsaxe, Gladsaxe Municipality, Denmark AGC Biologics Full timeJob Title: Associate Principal Scientist, Quality AssuranceWe are seeking an experienced Quality Assurance professional to join our team at AGC Biologics. As an Associate Principal Scientist, Quality Assurance, you will play a key role in ensuring the quality of our biologics manufacturing processes and products.Key Responsibilities:Support Supply Chain,...
-
Gladsaxe, Gladsaxe Municipality, Denmark AGC Biologics Full timeAt AGC Biologics, we strive to bring hope to life by enabling life-changing therapies for patients worldwide.Our QA Manufacturing Support Scientist plays a vital role in ensuring the quality and integrity of our manufacturing processes.The key responsibilities of this position include:Providing real-time quality support to manufacturing operations, ensuring...
-
Development Scientist
3 weeks ago
Gladsaxe, Gladsaxe Municipality, Denmark Novo Nordisk AS Full timeAbout the RoleWe are seeking a highly skilled Development Scientist to join our API Manufacturing Development team at Novo Nordisk. As a key member of our team, you will be responsible for handling enzyme manufacturing process optimization, supporting enzyme production facilities, and preparing and maintaining development documentation.Your Key...
-
Scientist in Enzyme Manufacturing
7 days ago
Gladsaxe, Gladsaxe Municipality, Denmark Novo Nordisk AS Full timeAbout the RoleWe are seeking a talented Scientist in Enzyme Manufacturing to join our team at Novo Nordisk A/S. The successful candidate will be responsible for handling enzyme manufacturing process optimization, supporting enzyme production facilities, and preparing development documentation.Main ResponsibilitiesEnzyme manufacturing process...
-
Senior Scientist, Quality Assurance Expert
3 weeks ago
Gladsaxe, Gladsaxe Municipality, Denmark AGC Biologics Full timeAbout the Role: We are seeking a highly motivated and experienced QA Scientist to join our team at AGC Biologics. As a key member of our Quality Assurance department, you will play a vital role in ensuring the quality and compliance of our manufacturing processes and facilities.Key Responsibilities: As a QA Scientist, you will be responsible for:Reviewing...
-
Scientist, Quality Assurance Specialist
2 months ago
Gladsaxe, Gladsaxe Municipality, Denmark AGC Biologics Full timeAbout the RoleWe are seeking a highly skilled Scientist, Quality Assurance Specialist to join our Quality Systems department. As a key member of our team, you will play a central role in enhancing our training standards to improve quality across the company.Key ResponsibilitiesCollaborate with partners to drive improvement projects optimizing our GMP...
-
Principle Quality Assurance Specialist
5 days ago
Gladsaxe, Gladsaxe Municipality, Denmark AGC Biologics Full timeJob SummaryAGC Biologics is seeking an experienced QA Scientist to join our team in Copenhagen. The successful candidate will be responsible for supporting Supply Chain, Process Transfer, and QC for late-stage and commercial products.Key ResponsibilitiesClose collaboration with internal stakeholdersChange control, deviation handling, and CAPAsReview and...
-
Senior Quality Assurance Specialist
6 days ago
Gladsaxe, Gladsaxe Municipality, Denmark AGC Biologics Full timeAbout the RoleWe are seeking a highly motivated and detail-oriented Quality Assurance (QA) Scientist to join our team at AGC Biologics. As a QA Scientist, you will play a crucial role in ensuring the quality of our products and processes, adhering to Good Manufacturing Practice (GMP) standards.Key ResponsibilitiesOversee the quality assurance review and...
-
Scientist, Quality Control Specialist
3 weeks ago
Gladsaxe, Gladsaxe Municipality, Denmark AGC Biologics Full timeThe RoleYou will be part of the Quality Control team at AGC Biologics, handling stability studies of Drug Substance, Drug Product, Placebo, and Reference Material. Your working day will involve ongoing collaborations with stakeholders such as customers, project managers, management, your own department, and QA.Your responsibilities will include:Writing and...
-
Senior Scientist, Quality Assurance Specialist
2 months ago
Gladsaxe, Gladsaxe Municipality, Denmark AGC Biologics Full timeJob Title: Senior Scientist, Quality AssuranceWe are seeking a highly motivated and experienced Senior Scientist to join our Quality Assurance team at AGC Biologics. As a key member of our team, you will be responsible for ensuring the quality and integrity of our products and processes.Key Responsibilities:Oversee the Quality Assurance review and approval...
-
Scientist, Quality Control Specialist
1 month ago
Gladsaxe, Gladsaxe Municipality, Denmark AGC Biologics Full timeThe RoleYou will be part of the QC Stability Team, a key component of Quality Control, responsible for handling stability studies of Drug Substance, Drug Product, Placebo, and Reference Material. Your day-to-day work will involve close collaborations with stakeholders such as customers, project managers, management, your own department, and QA.Your key...
-
Development Scientist
1 month ago
Gladsaxe, Gladsaxe Municipality, Denmark Novo Nordisk AS Full timeAbout the RoleWe are seeking a highly skilled Development Scientist to join our API Manufacturing Development team at Novo Nordisk A/S. As a key member of our team, you will be responsible for optimizing enzyme manufacturing processes, supporting enzyme production facilities, and preparing development documentation.Key ResponsibilitiesOptimize enzyme...
-
Development Scientist
1 month ago
Gladsaxe, Gladsaxe Municipality, Denmark Novo Nordisk AS Full timeAbout the RoleWe are seeking a highly skilled Development Scientist to join our API Manufacturing Development team at Novo Nordisk A/S. As a key member of our team, you will be responsible for optimizing enzyme manufacturing processes, supporting enzyme production facilities, and preparing development documentation.Key ResponsibilitiesOptimize enzyme...
-
Senior Scientist, Quality Control Specialist
1 month ago
Gladsaxe, Gladsaxe Municipality, Denmark AGC Biologics Full timeTransforming Lives through Innovative TherapiesAt AGC Biologics, we're driven by a shared purpose: to bring hope to life by enabling life-changing therapies for patients worldwide. Our mission is to collaborate closely with customers to improve patients' lives by introducing new biopharmaceuticals to the market.Join Our Team of ExpertsWe're seeking a highly...
-
Senior Quality Assurance Specialist in CMC API QA
2 months ago
Gladsaxe, Gladsaxe Municipality, Denmark Novo Nordisk AS Full timeAbout the RoleWe are seeking a highly motivated and experienced Senior Quality Assurance Professional to join our CMC API QA team. As a Senior QP Delegate, you will be responsible for releasing internal and externally produced API for usage in the Novo Nordisk clinical trial pipeline. You will also ensure compliance with regulatory requirements, quality...