Biologics Manufacturing Quality Assurance Specialist
5 days ago
We are seeking a highly motivated and detail-oriented Biologics Manufacturing Quality Assurance Specialist to join our team at AGC Inc.
About the Role:
The successful candidate will support the manufacture of biologics, on and off the plant floor, by providing quality assurance support under guided direction. This includes reviewing executed Master Production Records (MPRs) and other support documentation for completeness, compliance, and accuracy to support product lot disposition.
Key Responsibilities:
- Support the manufacture of biologics, on and off the plant floor, by providing quality assurance support under guided direction.
- Review executed Master Production Records (MPRs) and other support documentation for completeness, compliance, and accuracy to support product lot disposition.
- Collaborate with stakeholders to resolve GMP errors.
- Review QC data generated from manufactured product and intermediates and approve results summaries.
- Provide general support for other shifts, as needed, for activities from Manufacturing, Quality Control, and Engineering Operations.
Requirements:
- 0-2 years of relevant experience, BS/BA degree in Biology, Chemistry or other relevant discipline or equivalent work experience.
What We Offer:
At AGC Inc, we offer a competitive salary of $23.30 - $32.04 per hour, as well as a friendly, collaborative culture that values personal initiative and professional achievement. Our core values are Knowledge, Trust, Quality, Ingenuity, Accountability, and Teamwork.
About Us:
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 we work side-by-side with our clients and partners, every step of the way.
Contact Information:
-
Biologics Quality Assurance Specialist
2 weeks 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...
-
Copenhagen, Copenhagen, Denmark H. Lundbeck AS Full timeWe are seeking a highly skilled Senior Quality Control Scientist to join our CMC Biologics team at H. Lundbeck A/S in Copenhagen, Denmark.About the RoleThis is an excellent opportunity for a seasoned professional to take on a key position in ensuring the quality of our development biologics drugs from Phase I to Phase III.As Senior Quality Control Scientist,...
-
Copenhagen, Copenhagen, Denmark AGC Inc Full timeAGC 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...
-
Manufacturing Quality Assurance Specialist
4 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...
-
Biologics Quality Control Specialist
1 month ago
Copenhagen, Copenhagen, Denmark AGC Inc Full timeJoin Our QC Raw Materials Team as a Biologics Quality Control SpecialistWe are seeking a skilled Biologics Quality Control Specialist to join our dynamic team at AGC Inc.The ideal candidate will have an MSc or PhD degree in Pharmacy, Biotechnology, Biology, Chemistry, or similar, preferably with work experience within Quality Control and/or Quality Assurance...
-
Senior Quality Assurance Specialist
2 months ago
Copenhagen, Copenhagen, Denmark H. Lundbeck AS Full timeAbout the RoleWe are seeking a highly skilled Senior Quality Control Scientist to join our CMC Biologics Quality Control team. As a Senior Quality Control Scientist, you will be responsible for leading and executing quality control activities for drug-device combination products. You will work closely with contract manufacturing organizations (CMOs) to plan,...
-
Biologics Manufacturing Operations Specialist
3 weeks ago
Copenhagen, Copenhagen, Denmark AGC Inc Full timeJob SummaryWe are seeking a Biologics Manufacturing Operations Specialist to support our operations by reviewing inputs, documentation and records required for manufacturing of biologic products.This role is responsible for providing QA support under guided direction to operations and compliance with cGMP, FDA, and ICH. The ideal candidate will have a strong...
-
Senior Quality Assurance Specialist
4 weeks ago
Copenhagen, Copenhagen, Denmark H. Lundbeck AS Full timeAbout the Role: We are seeking a highly skilled Senior Quality Control Scientist to join our CMC Biologics team in Copenhagen, Denmark. As a key member of our team, you will be responsible for ensuring the quality of Lundbeck's development biological drugs from Phase I to Phase III.">Your Key Responsibilities:Technical lead and subject matter expert for...
-
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 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 AGC Biologics Full timeJob DescriptionThis is a high-profile leadership role that requires the ability to manage a team of experts in microbial downstream manufacturing. As Lead Microbial Manufacturing Operations Specialist, you will oversee daily production operations and ensure that they are conducted in a safe and compliant environment.The ideal candidate will have strong...
-
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...
-
Analytical Project Manager
2 days ago
Copenhagen, Copenhagen, Denmark AGC Biologics Full timeQuality Assurance Expert for Analytical ProjectsAbout AGC BiologicsAGC Biologics is a leading biopharmaceutical contract development and manufacturing organization (CDMO) that enables life-changing therapies for patients worldwide. With a strong commitment to quality, innovation, and collaboration, we strive to improve patients' lives by bringing new...
-
Biologics Process Development Specialist
1 month ago
Copenhagen, Copenhagen, Denmark AGC Inc Full timeUnlock Your Potential in BiopharmaceuticalsWe are seeking a talented Biologics Process Development Specialist to join our Late-Stage Process Development team. This exciting opportunity will allow you to contribute to the development of life-changing therapies and work collaboratively with our cross-functional team.About the RoleAs a Biologics Process...
-
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...
-
Senior Quality Assurance Specialist
1 month ago
Copenhagen, Copenhagen, Denmark H. Lundbeck AS Full timeAbout the RoleWe are seeking an experienced Senior Quality Control Scientist to join our CMC Biologics Quality Control team in Copenhagen, Denmark.Job DescriptionIn this role, you will be responsible for technical leadership and subject matter expertise in Quality Control activities with a focus on drug-device combination products. You will work closely with...
-
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...
-
Quality Assurance Specialist
2 months ago
Copenhagen, Copenhagen, Denmark Ferrosan Medical Devices AS Full timeAbout UsFerrosan Medical Devices A/S is an international company specializing in the development and production of medical devices for surgical care. Our portfolio includes hemostatic products and electromechanical devices for breast biopsies, registered in over 100 countries and marketed globally with medtech partners.Job SummaryWe are seeking a skilled...
-
Copenhagen, Copenhagen, Denmark Lundbeck AS, H Full timeLundbeck A/S, H is seeking an experienced Global Quality Assurance Specialist to strengthen our commercial manufacturing and distribution processes. The ideal candidate will have a strong quality mindset and be motivated by influencing the way we work with compliance and quality.We offer a dynamic role in a department with diverse areas of responsibility and...
-
Dental Quality Assurance Specialist
1 month ago
Copenhagen, Copenhagen, Denmark 3Shape Full timeAbout us3Shape is a global leader in 3D scanning and CAD/CAM solutions for dentistry. We're passionate about creating innovative technologies that empower dental professionals to deliver exceptional patient care.We're seeking a highly skilled Quality Assurance Specialist to join our team in Copenhagen, Denmark. As a key member of our quality assurance team,...