Quality Assurance Specialist in Biopharmaceutical Manufacturing
1 month ago
AGC Inc is a leading global biopharmaceutical Contract Development and Manufacturing Organization (CDMO) with a strong commitment to delivering the highest standard of service. As a Quality Assurance Specialist in our Copenhagen, Denmark facility, you will play a critical role in ensuring the quality and compliance of our manufacturing operations.
The estimated annual salary for this position is approximately $85,000-$110,000 depending on experience.
Job DescriptionAs a Quality Assurance Specialist, your primary responsibility will be to ensure that our manufacturing operations are compliant with Good Manufacturing Practices (GMP) regulations and company procedures. This includes:
- Providing real-time review of manufacturing records and logbooks
- Ensuring manufacturing compliance with applicable procedures and GMP requirements
- Working with Manufacturing Operations to resolve issues and implement improvements
To be successful in this role, you will need:
- Bachelor's and/or Master's degree in Natural Sciences or a related field
- At least 3-5 years of experience in a GMP environment within the pharma industry
- Strong working knowledge of GMP principles and guidelines
- Excellent written and verbal communication skills
- Ability to work in a fast-paced, matrix environment
As a Quality Assurance Specialist at AGC Inc, you can expect:
- A highly competitive compensation package
- A friendly, collaborative culture that values personal initiative and professional achievement
- Opportunities for growth and development in a dynamic and innovative organization
AGC Inc is a global biopharmaceutical CDMO with a strong commitment to delivering the highest standard of service. 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 multiple locations.
-
Copenhagen, Copenhagen, Denmark Ascendis Pharma AS Full timeAscendis Pharma A/S invites applications for a Quality Assurance Specialist to join their dynamic QA team in Copenhagen. As a key contributor, you will play a pivotal role in ensuring the QA oversight of outsourced development activities at Contract Laboratories and Manufacturing Organizations.About UsAs an innovative biopharmaceutical company, we leverage...
-
Copenhagen, Copenhagen, Denmark Ascendis Pharma AS Full timeJob OverviewWe are seeking a seasoned Development Quality Assurance (DQA) expert to join our innovative biopharmaceutical company, Ascendis Pharma A/S. As a DQA professional, you will be responsible for ensuring the quality oversight of outsourced development activities at Contract Laboratories and Manufacturing Organizations.Your role will involve driving...
-
Biologics Quality Assurance Specialist
2 days ago
Copenhagen, Copenhagen, Denmark Exokeryx, Inc. Full timeAs a Biologics Quality Assurance Specialist at Exokeryx, Inc., you will play a critical role in ensuring the highest standards of quality in our biopharmaceutical Contract Development and Manufacturing Organization (CDMO). Our team works side-by-side with clients and partners to deliver world-class development and manufacture of mammalian and microbial-based...
-
Manufacturing Quality Assurance Specialist
3 weeks ago
Copenhagen, Copenhagen, Denmark Agilent Technologies, Inc. Full timeJob SummaryWe are seeking a skilled Manufacturing Quality Assurance Specialist to join our team at Agilent Technologies, Inc.This role will be responsible for ensuring the highest quality standards in our manufacturing process.About the RoleThe ideal candidate will have a strong background in quality assurance and experience working with medical devices.A...
-
Copenhagen, Copenhagen, Denmark Lundbeck Full timeWe are seeking a highly skilled and experienced Quality Assurance Specialist to join our team at Lundbeck. This is an exciting opportunity to work with us as we strive to be the best possible customer for our Contract Manufacturing Organizations (CMOs).As a Quality Assurance Specialist, you will play a key role in supporting the standardization of our use of...
-
Quality Assurance Specialist
2 months ago
Copenhagen, Copenhagen, Denmark Lundbeck AS, H Full timeQuality Assurance Specialist Role We are seeking a Quality Assurance Specialist to strengthen our commercial manufacturing and distribution processes. This role will involve influencing the way we work with compliance and quality in Lundbeck. The Quality Assurance Specialist will be responsible for developing and facilitating global and local trainings for...
-
Copenhagen, Copenhagen, Denmark Lundbeck AS, H Full timeJob Summary:We are seeking an experienced Quality Assurance Professional to join our team in Lundbeck A/S, H. This role will involve strengthening commercial manufacturing and distribution processes through a strong quality mindset.About the Role:This exciting opportunity allows you to work in a department with diverse areas of responsibility and...
-
Biopharmaceutical IT Specialist
3 days ago
Copenhagen, Copenhagen, Denmark AGC Inc Full timeAre you passionate about delivering cutting-edge solutions in the biopharmaceutical industry?We are seeking an experienced IT Application Specialist to join our team at AGC Biologics.About the RoleThis is a unique opportunity to leverage your technical expertise and business acumen to drive innovation and excellence in our IT operations.Manage Configured...
-
Global Process Owner, Quality Assurance Specialist
2 months ago
Copenhagen, Copenhagen, Denmark H. Lundbeck AS Full timeAbout the RoleWe are seeking a highly skilled and experienced Quality Assurance professional to join our team as a Global Process Owner. In this role, you will be responsible for ensuring compliance across our supply chain, working closely with stakeholders to support line of business in achieving compliance.Key Responsibilities:Lead projects that...
-
Copenhagen, Copenhagen, Denmark Lundbeck Full timeJob Description:In this exciting role as a Quality Assurance Specialist, you will play a crucial part in standardizing the use of Contract Manufacturing Organizations (CMOs) globally for Lundbeck. This position is based in Valby and involves driving product and process improvements in a dynamic and international environment.Your Key Responsibilities:SUPPORT...
-
Senior Scientist, Quality Assurance Professional
1 month ago
Copenhagen, Copenhagen, Denmark AGC Inc Full timeAbout AGC BiologicsAGC Biologics is a leading global biopharmaceutical Contract Development and Manufacturing Organization (CDMO) with a strong commitment to delivering the highest standard of service. Our purpose is to bring hope to life by enabling life-changing therapies for patients around the globe.We provide world-class development and manufacture of...
-
Copenhagen, Copenhagen, Denmark Lundbeck Full timeAbout the RoleWe are seeking a highly skilled Lead Quality Assurance Specialist to join our CMC Development QA team at Lundbeck.Job DescriptionAs a Lead Quality Assurance Specialist, you will be responsible for ensuring the quality and compliance of our biologic drug products. You will work closely with cross-functional teams to identify and mitigate risks,...
-
Copenhagen, Copenhagen, Denmark Lundbeck Full timeLundbeck is seeking a Senior Quality Assurance Specialist to support the standardization of our partnerships with Contract Manufacturing Organizations (CMOs) and drive product and process improvements in a dynamic international environment.As a key member of our quality assurance team, you will leverage your risk assessment skills to determine and...
-
Copenhagen, Copenhagen, Denmark AGC Inc Full timeJob DescriptionAGC Inc is seeking a Quality Assurance Scientist to join our team.About the RoleThis position involves overseeing the quality assurance review and approval of technical documents, conducting GEMBA walks, and communicating with internal and external stakeholders.ResponsibilitiesReview and approve technical documents, including change controls,...
-
Product Quality Assurance Specialist
4 weeks ago
Copenhagen, Copenhagen, Denmark Lundbeck Full timeAs a Product Quality Assurance Specialist at Lundbeck, you will play a crucial role in standardizing the use of Contract Manufacturing Organizations (CMOs) across the globe. Your expertise in quality assurance and experience working with CMO-manufactured pharmaceuticals will be instrumental in driving product and process improvements.Our team is dedicated to...
-
Copenhagen, Copenhagen, Denmark Lundbeck Full timeJob DescriptionWe are seeking a highly skilled Senior Quality Assurance Specialist to join our team at Lundbeck. In this role, you will be responsible for standardizing the use of Contract Manufacturing Organizations (CMOs) globally and driving product and process improvements in a dynamic and international environment.About the RoleAs a Senior Quality...
-
Senior Quality Assurance Specialist
1 month ago
Copenhagen, Copenhagen, Denmark H. Lundbeck AS Full timeAbout the RoleWe are seeking a highly skilled Senior Quality Assurance Specialist to join our Corporate Product Quality Systems team at H. Lundbeck A/S.As a Senior Quality Assurance Specialist, you will play a key role in ensuring the quality of our commercial manufacturing and distribution processes.About the TeamYou will be part of a highly skilled team of...
-
Copenhagen, Copenhagen, Denmark Genmab Full timeAbout the RoleGenmab is seeking a Senior Biopharmaceutical Project Manager to join its Late-Stage Manufacturing Development Team in Copenhagen. The ideal candidate will support the CMC Lead of one of Genmab's late-stage development programs, coordinating and planning activities at partnered Contract Manufacturing Organizations (CMOs).Key...
-
Copenhagen, Copenhagen, Denmark Lundbeck Full timeTransform Lives with Quality Assurance at LundbeckLundbeck, a global leader in brain disorders treatment, is seeking a seasoned Quality Assurance Expert, Regulatory Compliance Specialist. Join our Corporate Product Quality Assurance team to contribute to developing business-driven quality functions while maintaining regulatory compliance.About the RoleThis...
-
Quality Assurance and Validation Specialist
2 months ago
Copenhagen, Copenhagen, Denmark DIS - CREADIS Engineering Solutions & Consulting Full timeJob Opportunity:We are seeking a qualified Quality Assurance and Validation Specialist to join our team at DIS - CREADIS Engineering Solutions & Consulting.About the Job:As a Quality Assurance and Validation Specialist, you will be responsible for ensuring the quality and compliance of our products and services. You will work closely with our clients to...