- Cedars-Sinai (Beverly Hills, CA)
- …all federal and local agencies including the Food and Drug Administration ( FDA ) and local Institutional Review Board (IRB). **Primary Duties and Responsibilities** + ... with all federal and local agencies including the Food and Drug Administration ( FDA and local Institutional Review Board. + Maintains research practices using Good… more
- Catalent Pharma Solutions (Chelsea, MA)
- …of International Quality and Compliance standards and requirements, with preferable FDA experience; + Demonstrated knowledge of Change management and Lean ... Regulatory Inspections from both EU and US Regulatory agencies such as MHRA, IBM, FDA , USDA; + Ability to work under pressure to meet tight and changing deadlines;… more
- Actalent (Houston, TX)
- …quality regulated environments such as healthcare and banking. + Familiarity with FDA Human Factors Regulatory Process/Requirements. + Knowledge of FDA Guidance ... on Human Factors, IEC standards, and HE75. Job Type & Location This is a Contract position based out of Houston, TX. Pay and Benefits The pay range for this position is $70.00 - $80.00/hr. Eligibility requirements apply to some benefits and may depend on your… more
- Mount Sinai Health System (New York, NY)
- …Experience in a supervisory capacity preferred. + Strong knowledge of GCP, FDA regulations, and other applicable clinical research guidelines. + Exceptional project ... Practice (GCP) guidelines, institutional policies, and applicable regulatory requirements (eg, FDA , IRB, ICH). + Oversee the preparation and submission of regulatory… more
- Actalent (Menomonee Falls, WI)
- …You'll design and implement comprehensive safety programs that meet OSHA, FDA , and pharmaceutical industry standards, ensuring compliance and protecting our ... & Implement Safety Programs: Create site-specific safety plans aligned with OSHA, FDA , and pharmaceutical standards. + Risk Assessment: Identify hazards related to… more
- Grifols Shared Services North America, Inc (Fayetteville, NC)
- …all state and federal regulations, US Food and Drug Administration ( FDA )-approved Standard Operating Procedure Manual, Occupational Safety and Health Administration ... highest production standards in accordance with Federal and State regulations, with FDA approved Standard Operating Procedure Manual, OSHA, CLIA and cGMP. + Attend… more
- Unither Pharmaceuticals (Rochester, NY)
- …assigned and maintains laboratory in compliance with SOPs, cGMPs, HS&E requirements, and FDA , DEA, USP, EP, and OSHA regulations. Trainees Demonstrate the Ability to ... BS in Microbiology[BB1] Chemistry with minimum of three (3) years' experience in an FDA regulated laboratory OR BS in life sciences with five (5) years' laboratory… more
- Aerotek (Medina, NY)
- …opportunities in a high-demand industry + **Clean, Climate-Controlled Facility:** FDA -regulated environment focused on safety and quality + **Comprehensive ... technical repairs + Complete documentation for quality compliance + Follow strict safety and FDA cGMP standards **✅ What We're Looking For** + High school diploma or… more
- Actalent (Arlington Heights, IL)
- …accuracy. + Conduct some instrument validation. + Adhere to GMP and FDA guidelines. + Ensure comprehensive documentation for testing protocols and executed tests. ... + Maintain data integrity in compliance with FDA guidelines. Qualifications + Bachelor's degree with a major in Chemistry (or related) + 3-5+ years of HPLC/GC and… more
- Medtronic (Boxborough, MA)
- …defects. Navigate the complexities of various medical device regulations and requirements to include FDA 21 CFR Part 11, ISO 14971, ISO 13485 and IEC 62304. Review ... software and hardware verification, troubleshooting, and identification and cataloging of software defects; FDA 21 CFR Part 11, ISO 14971, ISO 13485, and IEC 62304;… more