- Kelly Services (Torrance, CA)
- …of finished product in accordance with Client's SOPs, cGMP standards, and FDA regulations. **Responsibilities:** + Follow detailed batch records to accurately weigh, ... process issues in real time. + Ensure compliance with FDA and GMP guidelines for OTC manufacturing. + Adhere...cosmetic and/or OTC manufacturing environment. + Solid understanding of FDA , GMP, and SOP requirements in a regulated manufacturing… more
- Chiesi (Cary, NC)
- …documents and submissions (eg, INDs, BLAs/NDAs, supplements, amendments, and responses to FDA information requests). + Conducting background research on FDA ... have + Coursework or prior exposure to regulatory affairs, FDA regulations, or drug development. + Familiarity with ...FDA regulations, or drug development. + Familiarity with FDA regulatory pathways (eg, IND, NDA, BLA, orphan drug… more
- University of Pennsylvania (Philadelphia, PA)
- …contrast agents, including Hyperpolarized Xenon-129. These studies are conducted under FDA IND/IDE oversight in partnership with industry sponsors. The CRC-C will ... ideal candidate will bring prior experience supporting clinical trials under FDA IND or IDE oversight, particularly those involving investigational imaging agents… more
- Insight Global (Pleasant Prairie, WI)
- …ISO 9001, ISO 13485, FSSC 22000, and applicable regulatory requirements including FDA 21 CFR Part 820. The Specialist will collaborate cross-functionally to ensure ... controlled documents meet ISO 9001, ISO 13485, FSSC 22000, FDA (21 CFR part 820), and applicable regulatory standards....ISO 13485, FSSC 22000, and applicable regulatory requirements including FDA 21 CFR Part 820 requirements. - Proficiency in… more
- University of Colorado (Aurora, CO)
- …and effective policies, procedures, and processes to facilitate investigator initiated, FDA regulated clinical research on campus in a compliant and customer ... strategic opportunities. + Proven track record managing INDs/IDEs and interacting with FDA + Experience in the academic research environment + A combination of… more
- BeOne Medicines (Pennington, NJ)
- …and release of material, intermediates and finished products under FDA /EU regulations, applicable International Regulations, BeOne processes and procedures. ... working experience and 2 years managing laboratory analysts in an FDA -regulated biotechnology, pharmaceutical company with progressive levels of responsibility are… more
- Teleflex (Maple Grove, MN)
- …R&D cleanroom, ensuring effective engineering builds, compliance with ISO and FDA requirements and seamless coordination between R&D and manufacturing functions. The ... to ensure pilot line readiness and process optimization. * Ensure ISO 13485, FDA , and GMP compliance across all pilot line activities. * Maintain calibration,… more
- MPE Inc. (Sturtevant, WI)
- …variation. + Manages complaints, CAPA, non-conforming products per applicable ISO13485 and FDA requirements. + Manage inputs and KPI metrics for management review ... process per ISO13485 and FDA requirements. + Maintain Medical Device Files and records...a customer interface role + Experience with customer and FDA audits + Experience in problem identification, resolution and… more
- Grifols Shared Services North America, Inc (Research Triangle Park, NC)
- …centers in the United States consistently operate in full compliance with FDA and PPTA regulations, corporate quality standards, and industry best practices. The ... + **Compliance & Quality Oversight** + Ensure donor centers comply with US FDA , EMA, PPTA IQPP standards, CLIA/COLA, and state regulations. + Maintain audit and… more
- Veterans Affairs, Veterans Health Administration (Houston, TX)
- …compliance with all QC and QA requirements as per VHA policy, FDA /MQSA regulations, and ACR standards in mammography, tomography, breast ultrasound, and image ... the breast imaging section and assisting the department at annual FDA /MQSA inspections. When needed, the incumbent works closely with technologists, radiologists,… more
Recent Jobs
-
Skilled Trade - Plumber Pipefitter - Cleveland Engine
- Ford Motor Company (Cleveland, OH)
-
Lot Attendant
- The Hertz Corporation (College Park, GA)
-
Computer Vision Software Engineer, Senior (Level III)
- Lockheed Martin (Littleton, CO)
-
Ophthalmic Technician
- Vanderbilt University Medical Center (Nashville, TN)