Biotechnology Quality System Regulatory Specialist Jobs

88 jobs

At Joulé, you could say the right match is in our DNA. We're the specialists in Scientific Staffing. Our unmatched industry network and geographic reach enable us to place professionals like you at top firms every day. For more than 20 years, we've been providing temporary, contract and direct staff to pharmaceutical, biotechnology, food, flavor and fragrance, specialty chemical and other scientif...

We are currently seeking a Customer Quality & Regulatory Support Specialist who will be responsible for second level support of customer regulatory and quality inquiries referring to the whole Merck Millipore portfolio. A special focus will be on filtration in biopharmaceutical processes. The candidate should have an understanding of regulations relevant to biopharmaceutical and sterile drug manuf...

Senior Manager, Quality Systems: Attractive and Growing Biotech., NJ/NYC area Summary: We are working with a very attractive Biotech that is rapidly growing and stable. They have a newly created opening for a Senior Manager, Quality Systems. Given that this is a smaller organization, you will not be pigeon-holed and will have the opportunity to handle a diverse amount of Quality Systems responsib...

Description Level: E3 Summary Responsible for using validation experience to provide quality assurance oversight of the validation program to meet good manufacturing practices and the requirements of applicable Health Authorities. Supports the manufacturing, testing, disposition and distribution of Bulk Drug Substance. Ensures that Oceanside product(s) consistently meets customer and regulatory...

Description Summary Responsible for providing subject matter expertise in equipment/facilities/utilities validation, cleaning validation, process validation, or computerized systems validation to provide quality assurance oversight of the validation program to meet good manufacturing practices and the requirements of applicable Health Authorities. Supports the manufacturing, testing, disposition...

QA Specialist III, Technical Quality Requisition ID-3094842705 Description Level: E3 Summary Responsible for using validation experience to provide quality assurance oversight of the validation program to meet good manufacturing practices and the requirements of applicable Health Authorities. Supports the manufacturing, testing, disposition and distribution of Bulk Drug Substance. Ensures tha...

QA Senior Specialist, Technical Quality Requisition ID-3094842805 Description Summary Responsible for providing subject matter expertise in equipment/facilities/utilities validation, cleaning validation, process validation, or computerized systems validation to provide quality assurance oversight of the validation program to meet good manufacturing practices and the requirements of applicable ...

Description Senior Quality Systems Specialist We are currently seeking applications for the role of Senior Quality Systems Specialist, External Manufacturing. Reporting to the Associate Director, Global Quality Systems, the individual will be working in a team to support the following activities: • Maintain systems for the management of Quality Agreements, Annual Product Quality Reviews, CMO D...

Description Senior Quality Systems Specialist We are currently seeking applications for the role of Senior Quality Systems Specialist, External Manufacturing. Reporting to the Associate Director, Global Quality Systems, the individual will be working in a team to support the following activities: • Maintain systems for the management of Quality Agreements, Annual Product Quality Reviews, CMO D...

Merz North America is a specialty healthcare company dedicated to the development and marketing of innovative quality products for physicians and patients across the US and Canada. Our products are distributed through three divisions: Aesthetics/OTC , Dermatology , and Neurosciences . This position is located in our new North American headquarters in Raleigh, NC. Purpose:Responsible for the prep...

Advanced Instruments, Inc. is a leading supplier of instrumentation for clinical, pharmaceutical, biotechnology, microbiology and dairy laboratories around the world. While Advanced Instruments continues to be the world's foremost authority for the application of freezing-point depression technology, our analytical expertise has expanded to include cytology, infrared and image analysis. We are cur...

The Clinical Affairs Specialist I, under direct supervision, is responsible for the coordination and monitoring of domestic and international studies undertaken by Alere in support of research, marketing/sales and regulatory objectives. This may include the coordination of all product registration, regulatory submissions and related activities for domestic and international markets. Major Duties ...

Position Description The Regulatory Affairs Specialist is responsible for developing regulatory strategy, preparing global submissions and obtaining approval to introduce Medtronic MiniMed products and therapies to markets worldwide. This position primarily focuses on International. Position Responsibilities • Team with business unit Regulatory Affair Specialists and international regulatory st...

Professional Quality Trainer-70057832-56629 Description CAREER OPPORTUNITY LEARNING SPECIALIST Reference #56629 Sanofi Pasteur, the vaccines division of the Sanofi Group, is Canada’s oldest and largest vaccine company, with a proud heritage and a strong commitment to public health. Celebrating its 100th year in 2014, Sanofi Pasteur continues to provide essential, life-saving vaccines to milli...

Novavax, Inc. (Nasdaq: NVAX) is a clinical-stage biopharmaceutical company creating novel vaccines to address a broad range of infectious diseases worldwide. Using innovative virus-like particle (VLP) and recombinant nanoparticle technology, as well as new and efficient manufacturing approaches, the company produces potent vaccine candidates to combat diseases, with the goal of allowing countries ...

Our client, a leading medical device company, is currently seeking an accomplished Clinical Quality Assurance Specialist to join the team. Here is an overview of the role: 1) Plan, schedule and conduct internal and external quality assurance audits of the systems, clinical investigative site audits, procedures, and controls employed in the design, conduct, and analysis of clinical trials 2) Serv...

Fantastic Opportunity For a Senior Quality Assurance Specialist! Join our outstanding team at AMRI, recipient of the 2013 Leadership Award in Quality from "Life Science Leader" magazine! AMRI provides scientific services, products and technologies that improve quality of life while delivering excellence, value and maximum return. For more than 20 years, as Albany Molecular Research Inc. (AMRI),...

BioMarin leads the biotechnology industry in delivering therapies for chronic and degenerative genetic conditions that reduce patients' quality of life and shorten life spans. We target diseases that lack effective therapies and affect relatively small numbers of patients, many of whom are children. As we enter 2015, BioMarin will continue to focus on advancing therapies that are the first or best...

QA Specialist III, Documents Reports to: Sr. Manager, Quality Assurance Location: Cheshire, CT Global Level: SS05 Alexion Pharmaceuticals, Inc. is a biopharmaceutical company focused on serving patients with severe and ultra-rare disorders through the innovation, development and commercialization of life-transforming therapeutic products. Alexion is the global leader in complement inhibition, ...

Description CSC has an immediate opportunity for a Document Control Specialist who possesses strong writing, editing and word processing skills. The qualified candidate should have experience with electronic document management systems in the biologics, pharmaceutical and/or medical device industry. This position is located in Frederick, Maryland. Essential Job Functions Maintain accurate and s...