Biotechnology Quality System Regulatory Specialist Jobs

103 jobs

Passionate About Science We’re passionate and rigorous about our science. For more than 30 years, Genentech has been at the forefront of the biotechnology industry, using innovative science to develop breakthrough medicines that improve the lives of people with serious or life-threatening diseases. The following opportunity exists in our Oceanside, CAheadquarters: QA Senior Specialist, Technica...

Passionate About Science We’re passionate and rigorous about our science. For more than 30 years, Genentech has been at the forefront of the biotechnology industry, using innovative science to develop breakthrough medicines that improve the lives of people with serious or life-threatening diseases. The following opportunity exists in our Oceanside, CA headquarters: QA Specialist III, Technical ...

Responsible for all activities involving Quality Assurance and Compliance with applicable regulatory requirements with a focus on Laboratory Compliance. A wide degree of creativity and latitude is necessary. A minimum amount of supervision should be needed. Provide QA oversight to QC operations to include the following: Review and approve SOPs and specifications Review and approve validation do...

Eppendorf is looking for a Regulatory/Compliance Engineer; an integral member of the Quality and Regulatory team in Enfield, CT. Key Responsibilities: This candidate will contribute to the success of the Quality and Regulatory team and will also demonstrate the following skills and capabilities including but not limited to: · Sole responsibility for development, maintenance, support and coordin...

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 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...

Quality Systems Specialist Needed in Lexington, MA Every day, Kelly Services connects professionals with opportunities to advance their careers. We currently have a contract opportunity with a global leader in the biotechnology industry in Lexington, MA. ASSIGNMENT LENGTH: End of 2015 SUMMARY The Quality Systems Specialist will establish and update quality systems procedures to ensure device a...

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...

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 ...

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...

QA Senior Specialist, Environmental Quality Requisition ID -2571909027 The Position · Approve discrepancies following cGMP regulations and Roche standards. · Approve significant (i.e. OOS) discrepancies and ensure laboratory investigations are thorough, timely, unbiased, well-documented, and scientifically sound. · Ensures effective corrective and preventive actions are systematically identi...

QA Senior Specialist, Environmental Quality Requisition ID-2571909027 Description · Approve discrepancies following cGMP regulations and Roche standards. · Approve significant (i.e. OOS) discrepancies and ensure laboratory investigations are thorough, timely, unbiased, well-documented, and scientifically sound. · Ensures effective corrective and preventive actions are systematically identifie...

Description · Approve discrepancies following cGMP regulations and Roche standards. · Approve significant (i.e. OOS) discrepancies and ensure laboratory investigations are thorough, timely, unbiased, well-documented, and scientifically sound. · Ensures effective corrective and preventive actions are systematically identified, analyzed, implemented and documented to prevent recurring problems an...

Job Description : PAREXEL International Corporation is a leading global bio/pharmaceutical services organization, providing a broad range of knowledge-based contract research, consulting, and medical communications services to the worldwide pharmaceutical, biotechnology and medical device industries. Committed to providing solutions that expedite time-to-market and peak-market penetration, PAREXE...

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 ...

Are you a clinical professional looking to expand your experience and broaden your career horizon? This is the position for you – utilize your clinical experience in the Quality arena. PRIMARY PURPOSE OF POSITION: This QA position is a member of the Quality team and provides QA support and oversight to ensure compliance with Good Clinical Practice (GCP). Areas of responsibilities include, but ar...

Partner with the Clinical Department to ensure all clinical trials are assessed for compliance with SOPs, FDA and other applicable regulations, and ICH/GCP guidelines. Review departmental procedures and clinical documents from a GCP Compliance perspective and provide supervisor with reports of compliance matters. Plan and/or conduct audits, including external vendors, Trial Master File, clinical...