Biotechnology Quality System Regulatory Specialist Jobs

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120 Biotechnology Quality System Regulatory Specialist jobs found on Monster.

Jobs 1 to 20 of 120
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...
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...
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...
Merz Pharmaceuticals LLC Raleigh, NC, 27611
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 relocated in our new North American headquarters in Raleigh, NC. Purpose:Responsible for the pr...
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...
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...
Position Description The Associate 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...
Senior QA Specialist/QA Specialist III Requisition ID-2975994044 Description Openings: 1 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 o...
Description Openings: 1 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 stakeh...
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 dep...
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 department objectives Job Duties/Responsibilities: Follow company poli...
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...
Requisition ID 25657BR Title PROJECT SPECIALIST Job Category Project Management Job Description Job Summary Responsible for managing and executing large-scale improvement projects from scope development and project planning through project closeout. Accountable for engaging project teams and maximizing utilization of available resources associated with assigned projects. Leads efforts to analy...
Site Compliance - Qa Specialist Requisition ID-2964169958 Description Main Purpose of the Position: · Independently lead/participate on GMP compliance audits and identify GMP compliance gaps or risks. · Provide GMP Compliance expertise to customers. · Develop solutions to complex issues and Quality initiatives with inter-organizational impact, following cGMP regulations and Genentech standar...
QA Specialist III Requisition ID-2566383905 Description Summary Responsible for providing comprehensive technical support and quality assurance oversight 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 our custo...
Description Main Purpose of the Position: · Independently lead/participate on GMP compliance audits and identify GMP compliance gaps or risks. · Provide GMP Compliance expertise to customers. · Develop solutions to complex issues and Quality initiatives with inter-organizational impact, following cGMP regulations and Genentech standards · Perform tasks and work to achieve company goals and or...
Description Summary Responsible for providing comprehensive technical support and quality assurance oversight 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 our customer and regulatory requirements. Ability to ...
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...

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