- PCI Pharma Services (Philadelphia, PA)
- …Manager is responsible for the safety, quality, and operational excellence for Advanced Drug Delivery value stream. In this role they provide leadership to the ... procedures, along with all federal, state and local regulations, including OSHA, FDA , cGMP standards and employment law + Demonstrate substantial knowledge of the… more
- Otsuka America Pharmaceutical Inc. (Harrisburg, PA)
- …potentially formulation/fill-finish operations. + Experience with cGMP manufacturing environments and regulatory requirements ( FDA , EMA, ICH). + Familiarity with ... review technical reports, protocols, risk assessments, and relevant sections of regulatory submissions (IND, BLA, MAA, etc.) related to downstream processing. +… more
- Northern Light Health (Portland, ME)
- …with the Office of Human Research Protections (OHRP) and the Food and Drug Administration ( FDA ). The incumbent performs duties in accordance with performance ... of Human Research Protections (OHRP) and the Food and Drug Administration ( FDA ). + Maintains updated ...subject research. + Plays a key role in routine FDA audits for regulatory and legal compliance.… more
- Abbott (San Juan, PR)
- …device and system troubleshooting as needed. + Complies with US Food and Drug ( FDA ) regulations, other regulatory requirements, company policies, operating ... of Quality Management Systems (QMS), Environment Management Systems (EMS), and other regulatory requirements. + Assist hospital procedures, playing a key role in the… more
- J&J Family of Companies (Raritan, NJ)
- …of medical device regulations, standards, and regulatory bodies, eg FDA (Food and Drug Administration), ISO (International Organization for Standardization, ... Risk Management, Quality Engineering, Supply Chain, Quality Systems, Compliance, and Regulatory Affairs. + Identify and pursue design control system improvement… more
- Mohawk Valley Health System (Utica, NY)
- …Environmental Radiation Protection (DOH-BERP), American College of Radiology (ACR) Food & Drug Administration ( FDA ), Nuclear Regulatory Commission (NRC) and ... and standards. + Acts as team lead for accreditation and regulatory /compliance inspections. Initiates any remedial action and completes corrective action plan.… more
- State of Colorado (Denver, CO)
- …Act, milk producer laboratories and other milk testing laboratories under the Food and Drug Administration ( FDA ) Grade A Pasteurized Milk Ordinance of 1995, and ... law enforcement and private alcohol and drug testing laboratories under the Colorado State Board of...apply to laboratory testing + In-depth knowledge of laboratory regulatory requirements (eg, CLIA, EPA, FDA , ISO)… more
- Stony Brook University (Stony Brook, NY)
- …a minimum of three (3) professional references. + Successfully complete a 4-panel drug screen * + Meet Regulatory Requirements for pre-employment screenings. + ... The Investigator Initiated Trial Specialist provides operational support and regulatory management for investigator-initiated clinical research at Stony Brook Cancer… more
- Guthrie (Sayre, PA)
- …+ Minimum 3-5 years of direct experience in clinical or pharmaceutical-sponsored research or regulatory fields such as the FDA , NIH, or HHS. + Minimum 5 ... + Advises The Guthrie Clinic senior leadership on HRPP regulatory issues. + Oversee FDA inspections, audits,...scientific review, funding and resource allocation. Communicate directly with FDA for investigational new drug (IND) and… more
- University of Rochester (Rochester, NY)
- …knowledge and expertise of quality standards as set forth in 21 CFR under the FDA and other regulatory agencies, the EU Clinical Trial Directives, and other ... requirements. + Oversees internal and external audits to ensure compliance with global regulatory standards, including FDA , EMA, and ISO guidelines. + Drives… more
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