- Actalent (Melville, NY)
- …+ Inspect all incoming and bulk finished goods + Batch Record Review + QA Line Clearance + Quality control + GMP + FDA regulations + Quality check + ... Work Environment The QA Inspector will work inside an FDA -regulated facility with specifications similar to a clean room....a team. The QA team ensures that everyone follows FDA regulations and company SOPs during the manufacturing and… more
- Cambrex High Point (Waltham, MA)
- …Snapdragon Chemistry is currently seeking exceptional candidates for its Director of Quality Assurance - GMP Manufacturing (Synthetic APIs) position. A ... leadership role is responsible for overseeing all aspects of Quality Assurance in a GMP manufacturing environment...management. + Ensure compliance with global regulatory requirements (eg, FDA , EMA, ICH) for API manufacturing and quality… more
- ThermoFisher Scientific (Cincinnati, OH)
- …Conditions** Office **Job Description** **Summary:** Investigates and observes Operations and Quality Operations departments to assure that FDA current Good ... the Code of Federal Regulations. Assists the Operations and Quality Operations departments in satisfying all FDA ...incidents that require management's review and action. + Conducts GMP inspections of facilities to assure compliance with the… more
- The US Pharmacopeial Convention (USP) (Rockville, MD)
- …with the world's top authorities in health and science to develop quality standards for medicines, dietary supplements, and food ingredients. USP's fundamental ... that Equity = Excellence manifests in our core value of Passion for Quality through our more than 1,300 hard-working professionals across twenty global locations to… more
- Mayo Clinic (Jacksonville, FL)
- …and inclusion, and provides the resources you need to succeed. **Responsibilities** The Sr. Quality Analyst, FDA Regulated Manufacturing will be part of a team ... related field is preferred or a bachelor's degree, 5 years' experience supporting FDA regulated product manufacturing, and 5 years quality , regulatory, or… more
- ThermoFisher Scientific (Cincinnati, OH)
- …**Environmental Conditions** Office **Job Description** Investigates and observes Operations and Quality Operations departments to assure that FDA current Good ... the Code of Federal Regulations. Assists the Operations and Quality Operations departments in satisfying all FDA ...of management + Assist on functional area GEMBAs and GMP inspections of facilities to assure compliance with the… more
- BioFire Diagnostics, LLC. (Lombard, IL)
- …Minimum of 1 year of experience in training development, ideally in an FDA -regulated setting. + Instructional design or GMP -related certifications are preferred. ... all shifts. This role focuses on maintaining compliance with FDA , ISO 13485, ISO 9001, ISO 14001, and ISO...with LMS platforms, particularly ComplianceWire. + Strong understanding of GMP , Good Documentation Practices, and quality systems… 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
- Actalent (New Albany, OH)
- …document information. Essential Skills + High School Diploma or GED. + Experience in GMP , FDA , or strict SOP environments preferred. + Comfortable working in ... GMP Technician Job Description We are seeking a...+ Follow SOPs, GMPs (Good Manufacturing Practices), and all FDA regulations. + Conduct component preparation, aseptic cleaning, equipment… more
- ThermoFisher Scientific (St. Louis, MO)
- …on phase appropriate FDA , EMA and ICH guidelines. + Perform routine quality walk throughs of assigned production and production support areas. + Participate in ... Assurance, Quality Operations, or Compliance preferred. Ability to apply GMP /GLP regulations and other international guidelines to all aspects of the position.… more
- Adecco US, Inc. (Mansfield, MA)
- …(1) years experience in manufacturing operations with medical devices. * Knowledge and experience with GMP , ISO, FDA , and quality standards * Experience in a ... as required by clients. Adherence to Good Manufacturing Practices ( GMP ) and FDA , ISO, and environmental requirements....as required by the company - Production accuracy and quality - Accurately follow manufacturing procedures and quality… more
- Adecco US, Inc. (St. Charles, IL)
- …years' experience in manufacturing operations with medical devices. + Knowledge and experience with GMP , ISO, FDA , and quality standards + Experience with ... required by clients. Requires adherence to Good Manufacturing Practices ( GMP ) and FDA , ISO, and environmental requirements...sequence of work + Make simple direct reading of quality checks of parts and assemblies, reporting any unusual… 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 a Director of GMP Compliance & Inspections position. This position will work with cross-functional teams to drive activities that… more
- Actalent (Hilliard, OH)
- …within, and provide valuable experience working in a heavily regulated environment (following GMP and FDA regulations). An ideal candidate will have reliable ... maintain filling equipment and troubleshoot when necessary while performing quality checks. + Gown up for the majority of...GED. + Must have manufacturing experience. + Experience in GMP , FDA , or following strict SOP environments… more
- Regeneron Pharmaceuticals (Troy, NY)
- The Staff GMP Data Governance Specialist plays a pivotal part in ensuring that Regeneron's Data Governance systems and practices meet the highest standards of ... with regulatory requirements and industry standards. As a Staff GMP Data Governance Specialist, a typical day might include...plan. Lead DI remediation activities as per the DI Quality Plan. + Work in partnership with other Technical… more
- Novo Nordisk (Clayton, NC)
- …+ Minimum of three (3) years progressively responsible experience in material management &/or GMP quality , required + Experience in one or more of the following ... At Novo Nordisk, we are helping to improve the quality of life for millions of people worldwide. For...+ API & raw materials a plus + Regulations GMP &/or ISO a plus + Pharmaceutical or other… more
- Regeneron Pharmaceuticals (Troy, NY)
- …and the following amount of experience in one of the following pharmaceutical/ FDA regulated work areas: data management, quality assurance, compliance, ... We are currently looking to fill a Director of GMP Data Governance position. This position acts as a...unit(s). It plays an integral part in safeguarding the quality and reliability of the organization's data which is… more
- ThermoFisher Scientific (Middleton, WI)
- …lift 40 lbs. without assistance, Adherence to all Good Manufacturing Practices ( GMP ) Safety Standards, Cleanroom: no hair products, jewelry, makeup, nail polish, ... digital and decentralized clinical trial services. Your determination to deliver quality and accuracy will improve health outcomes that people and communities… more
- ThermoFisher Scientific (Middleton, WI)
- …(Mon-Fri) **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
- 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