- Beckman Coulter Diagnostics (Miami, FL)
- …including GMP and QSR requirements for medical devices. (ISO13485, FDA 's QSRs, EU's MDD, Canadian Regulations) is required. Proficiency in the Microsoft ... certification is preferred.Demonstrates knowledge of domestic and international quality systems and other standards such as FDA... quality systems and other standards such as FDA QSR, MDD, CMDCAS, SFDA, JPAL, ISO 13485, ISO… more
- Aldevron (Miami, FL)
- …in a Quality with experience working in a regulated or GMP compliant environment and leading projects or related experience.Exposure to regulatory agency ... inspections or other types of audits (eg, FDA , notified bodies, ISO, etc.).Current or past ... FDA , notified bodies, ISO, etc.).Current or past Quality certifications a plus (eg ISO 9001, ASQ, etc.)Strong… more
- Cytiva (Miami, FL)
- …production.2+ years experience with regulatory standards and quality systems (eg, FDA , ISO 13485, Good Manufacturing Practices - GMP ).2+ years experience ... manufacturing processes, managing projects, and ensuring the efficient production of high- quality medical devices and products in a regulated environment. The ideal… more
- Pall (Miami, FL)
- …understanding of ISO 9001 and AS9100 / CAA Part 145/CAA Part 21 standards. GMP , FDA knowledge and other ISO standards an advantage.Good understanding of ... Pall is there, helping protect critical operating assets, improve product quality , minimize emissions and waste, and safeguard health. For the exponentially… more
- Aldevron (Fargo, ND)
- …solutions that safeguard and improve human health.This position is part of the Quality and Regulatory Affairs Department located in Fargo, North Dakota and will be ... validation with minimal assistance.Collaborate with Analytical Method Development and Quality Control (QC) Laboratory Associates to support the implementation of… more
- Aldevron (Fargo, ND)
- …solutions that safeguard and improve human health.This position is part of the Quality and Regulatory Affairs Department located in Fargo, North Dakota and will be ... and instrumentation. Work closely with Analytical Method Development and Quality Control (QC) Laboratory Associates to ensure successful implementation of… more
- Kelly Services (Anasco, PR)
- …preferred. + Experience in the Medical Device industry is preferred. + Knowledge of FDA / GMP regulatory or quality assurance experience is a plus. As ... Storage** : 2. Receive and store materials following Good Manufacturing Practices ( GMP ) to ensure product integrity. 3. Prevent mixing of components and facilitate… more
- Kelly Services (South San Francisco, CA)
- …the pharmaceutical or biotechnology industry. + Strong understanding of regulatory requirements ( FDA , EMA, ICH, GMP ) and quality management principles. ... ** Quality Systems Specialist** Kelly(R) Science & Clinical is seeking a Quality Systems Scientist for **a temp-to-hire** position at **an early-stage biotech**… more
- AMETEK.Inc (Mansfield, MA)
- …years' experience in manufacturing operations with medical devices. + Knowledge and experience with GMP , ISO, FDA , and quality standards + Experience with ... medical devices as required by clients. Requires adherence to Good Manufacturing Practices ( GMP ) and FDA , ISO, and environmental requirements and must adhere to… more
- Regeneron Pharmaceuticals (Troy, NY)
- …Specialist : 8+ years of professional experience or equivalent in pharmaceutical/ FDA -regulated environments such as data management, quality assurance, ... operations, quality control, or IT. + Staff GMP Data Governance Specialist: 10+ years of professional experience...of federal, state, and local regulations (eg, GDPR), including FDA , EMA, and WHO guides on data integrity. +… more
- Mentor Technical Group (Juncos, PR)
- …(MTG) provides a comprehensive portfolio of technical support and solutions for the FDA regulated industry. As a world leader in life science engineering and ... Puerto Rico, Dominican Republic, Mexico, Germany, Canada and South America. The GMP Cleaning and Sanitization Group Leader will assist the Supervisor in ensuring… more
- Regeneron Pharmaceuticals (Rensselaer, NY)
- …health authorities (eg FDA , EMA, MHRA, etc.) + Excel in a quality driven organization + Have an understanding of biologics manufacturing operations To be ... We are currently looking to fill an Associate Director of GMP Compliance & Inspections position. This position will work with cross-functional teams to drive… more
- ThermoFisher Scientific (Boston, MA)
- …guidance. In addition, this role will be responsible for supporting various GMP stability testing programs and Quality Systems, including handling stability ... (Mon-Fri) **Environmental Conditions** Adherence to all Good Manufacturing Practices ( GMP ) Safety Standards **Job Description** At Thermo Fisher Scientific, you'll… more
- ThermoFisher Scientific (Middleton, WI)
- …**Environmental Conditions** Adherence to all Good Manufacturing Practices ( GMP ) Safety Standards, Cold Room/Freezers -22degreesF/-6degrees C, Laboratory Setting, ... digital and decentralized clinical trial services. Your determination to deliver quality and accuracy will improve health outcomes that people and communities… more
- ThermoFisher Scientific (North Chicago, IL)
- …(Days) **Environmental Conditions** Adherence to all Good Manufacturing Practices ( GMP ) Safety Standards **Job Description** At Thermo Fisher Scientific, you'll ... digital and decentralized clinical trial services. Your determination to deliver quality and accuracy will improve health outcomes that people and communities… more
- Mentor Technical Group (College Station, TX)
- …provides a comprehensive portfolio of technical support and solutions for the FDA -regulated industry. As a world leader in life science engineering and technical ... work is started, monitor work being completed, verify work completed and check quality of work. + Maintain cGMP records, both paper-based and electronic. +… more
- Conagra (Indianapolis, IN)
- …and processes. You will need a sound knowledge of product types, department rules, GMP 's, FDA , OSHA, Safety, Quality and technical skills relative to ... Defect Handling, Planning/Scheduling etc. + You will improve 5S, housekeeping and GMP , in relation to tools, shop safety and equipment repair. **QUALIFICATIONS:**… more
- Caldera Medical (Westlake Village, CA)
- …Provides a key role in assuring organizational compliance to the defined Caldera Medical quality system, FDA QSR/ GMP regulations, ISO 13485 quality ... Sr. Quality Engineer Caldera Medical's Mission - To Improve...certifications (preferred). Skills & Knowledge: * Deep knowledge of FDA regulations (21 CFR Part 820), ISO 13485, ISO… more
- US Tech Solutions (Kennebunk, ME)
- … quality systems, and governmental regulations (OSHA, ISO 13485, QSR, FDA , GMP , etc.). + Support the Quality , Operations and Engineering teams in process ... and infrastructure resulting in a superior product and process in terms of quality and cost. **Major Roles and Responsibilities:** + Actively collaborate with other… more
- Abbott (Pleasanton, CA)
- …manufacturing + Credentials of a Certified Quality Engineer + Knowledge of GMP , ISO, FDA regulations, and quality systems auditing + Strong ... people to restore their health and get on with their lives. As the Quality Engineer II Risk Management, you will Works closely with cross functional teams to… more
