Biotechnology Quality System Regulatory Specialist Jobs

92 jobs

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...

QUALITY SYSTEMS SPECIALIST REQUIREMENT #15-01047 RECRUITER: DIANA WRIGHT JOB LOCATION: NEW BRUNSWICK, NJ JULY 27, 2015 Project Description: This position is responsible for implementing quality systems within the External Manufacturing organization. Liaise with internal Global Regulatory Sciences group to support requests related to regulatory submissions and follow through on regulatory act...

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...

GCP Quality Specialist/ Manager Required ASAP Berkeley, CA-94701 Permanent Role Multiple Roles GCP with Clinical operations background is a MUST Client is into Clinical domain with a rigorous approach to drug development in the field of TLR biology and immune system Responsibilities: Partner with the Clinical Department to ensure all clinical trials are assessed for compliance with SOPs, FD...

Known for its scientific and operational excellence, Regeneron is a leading science-based biopharmaceutical company that discovers, invents, develops, manufactures, and commercializes medicines for the treatment of serious medical conditions. Regeneron markets medicines for eye diseases, colorectal cancer, and a rare inflammatory condition and has product candidates in development in other areas o...

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...

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...

COMPANY DESCRIPTION Applied BioCode is a privately held biotechnology company with headquarters in Santa Fe Springs, California. Applied BioCode manufactures and markets Barcoded Magnetic Beads (BMB) and detection systems for the development of highly multiplexed nucleic acids or protein detection assays which are applicable to the clinical diagnostic, life science research, and agricultural test...

At XBiotech we are rethinking the way medicines are discovered and commercialized—from pioneering ways to create safer drugs that harness our natural immunity to disease, to developing technology that enables rapid transition from discovery to large-scale manufacturing. At XBiotech we believe there is vast potential for next generation antibody therapies derived from natural immunity to disease. W...

Company Overview: Canon BioMedical, Inc. is a subsidiary of Canon U.S.A., Inc. Canon U.S.A., Inc., is a leading provider of consumer, business-to-business, and industrial digital imaging solutions to the United States and to Latin America and the Caribbean (excluding Mexico) markets. With approximately $31 billion in global revenue, its parent company, Canon Inc. (NYSE:CAJ), ranks third overall ...

Your Challenge The Regulatory Affairs Specialist will support regulatory affairs activities at Philips Oral Healthcare in Bothell, WA. The RA Specialist will execute activities as defined by the RA Manager and aligned with capabilities; supporting RA operations and administration, systems building, regulatory compliance and global submission activities for all Philips Oral Healthcare products (Me...

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 ...

Known for its scientific and operational excellence, Regeneron is a leading science-based biopharmaceutical company that discovers, invents, develops, manufactures, and commercializes medicines for the treatment of serious medical conditions. Regeneron markets medicines for eye diseases, colorectal cancer, and a rare inflammatory condition and has product candidates in development in other areas o...

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 ...

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 ...

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...

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: · Act as sole contributor for development, maintenance, support and coo...

QA Specialist III/QA Senior Specialist Requisition ID -2812525416 The Position Openings: 1 Main Purpose: Provide Quality oversight for issues of significant scope and complexity across multiple functional groups in order to ensure adherence to cGMP regulations and Genentech quality standards Provide Change Control Quality oversight for SSF Clinical and Commercial Drug Product Manufacturing ...

QA Specialist III Reports to: Associate Director, 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, and ...

QA Specialist III Reports to: Associate Director, 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, and ...