Biotechnology Quality System Regulatory Specialist Jobs

Currently, there are no Biotechnology Quality System Regulatory Specialist jobs available which match this search. You may wish to explore similar job titles on the Biotech jobs page or view related jobs below.
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This position ensures that processes and systems; such as IQ/OQ/PQ of facilities, equipment and analytical laboratory software, within the cGMP laboratory support groups, are fully qualified and performing efficiently. Responsible for developing, recommending, and executing validation strategies and designing studies for the purpose of providing documented evidence that a systems, equipment, inst...
Analytical and Process (A&P) Calibrations serves the biotechnology, microchip and other manufacturing industries in the San Francisco Bay Area and beyond. Since its founding, we have applied more than 25 years of experience in the calibration services industry, combined with our experience as end users of calibration equipment in the biotechnology industry, to our professional, high quality calibr...
Description Key Responsibilities: Be the Site contact for the Annual Product Quality review (APQR). Collect and provide on time the executive summary reports as required by the GSP and the corporate APQR team. Coordinate and communicate with different functional groups / department both on site and global to consolidate individual data summaries for APQR process. Participate to the APQR meetin...
Description Key Responsibilities: Lead the Site Inspection Management (SIM) for the site for Health Authorities, Corporate audit and partner audit. Lead and create all necessary activities required to prepare an inspection (identification of risks, preparation of pre-request, ART room set-up, SWAT team, logistic…). Be able to take a leadership role during an inspection Lead the site inspectio...
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...
Waters Division Milford, MA
Company Description: For over 50 years, Waters Corporation has developed innovative analytical science solutions to support customer discoveries, operations, performance, and regulatory compliance. Specifically, the company designs, manufactures, sells, and services high performance liquid chromatography, ultra performance liquid chromatography, and mass spectrometry technology systems and suppor...
Position Description The Regulatory Affairs Specialist will provide domestic and international regulatory affairs support for Medtronic MiniMed products. This includes preparing U.S. and International submissions and technical files to support market-released products. Position Responsibilities • Team with business unit Regulatory Affair Specialists and international regulatory staffs to provid...
Philips Bothell, WA
Regulatory Affairs Specialist 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 Phil...
Waters Milford, MA
Company Description: For over 50 years, Waters Corporation has developed innovative analytical science solutions to support customer discoveries, operations, performance, and regulatory compliance. Specifically, the company designs, manufactures, sells, and services high performance liquid chromatography, ultra performance liquid chromatography, and mass spectrometry technology systems and suppor...
Danaher Corporation Miami, FL
Senior Staff Regulatory Affairs Specialist-DIA002235Danaher Company DescriptionBeckman Coulter develops, manufactures and markets products that simplify, automate and innovate complex biomedical testing. Our diagnostic systems are found in hospitals and other critical care settings around the world and produce information used by physicians to diagnose disease, make treatment decisions and monitor...
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 (M...
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...
Role Summary Responsible for coordination of technology transfer activities, assay qualification and validation design and execution, Quality Control (QC) department representation at routine contract manufacturing client meetings, review of statements of work (SOW) in support of contract manufacturing, and new product assessment and setup activities. Will serve as lead for complex technical inv...
Summary: C S Bio is a fast paced growing Peptide CMO founded in 1993. Our initial products were a complete line of automated synthesizers for manufacturing and process development, with a focus on cGMP production. In 1994, we opened our custom peptide facility. Initially opened to support R&D for our instrument line, we soon began producing high quality compounds for research organizations and ph...
QA Senior Specialist/QA Specialist III Requisition ID -2768024715 The Position Summary: Support the site in preparing for, executing, and responding to Regulatory Inspections, Partner Inspections, and Audits Solve a wide range of difficult issues that impact multiple functions, following cGMP regulations and Genentech standards Perform assigned tasks and work to achieve company goals and de...
QA Senior Specialist/QA Specialist III Requisition ID-2768024715 Description Summary: Support the site in preparing for, executing, and responding to Regulatory Inspections, Partner Inspections, and Audits Solve a wide range of difficult issues that impact multiple functions, following cGMP regulations and Genentech standards Perform assigned tasks and work to achieve company goals and depar...
Senior QA Specialist Requisition ID -2573448628 The Position Main Purpose: Deploy a program for GMP maintenance compliance that ensures robust validation, consistency in decision-making, and clarity of requirements Ensure establishment and maintenance of validated state for systems and processes at the South San Francisco according to cGMP standards reflected in our pharmaceutical quality sy...
Senior QA Specialist Requisition ID-2573448628 Description Main Purpose: Deploy a program for GMP maintenance compliance that ensures robust validation, consistency in decision-making, and clarity of requirements Ensure establishment and maintenance of validated state for systems and processes at the South San Francisco according to cGMP standards reflected in our pharmaceutical quality syste...
Description Main Purpose: Deploy a program for GMP maintenance compliance that ensures robust validation, consistency in decision-making, and clarity of requirements Ensure establishment and maintenance of validated state for systems and processes at the South San Francisco according to cGMP standards reflected in our pharmaceutical quality system documents Collaborate with stakeholders in Fac...
Regeneron Pharmaceuticals Rensselaer, NY, 12144
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...

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