- Exela Pharma Sciences, LLC (Lenoir, NC)
- …procedures, corporate policies and the regulatory requirements of the US Food and Drug Administration.Experience RequirementsKnowledge and experience with FDA ... well as reviewing and approving data associated with Raw Material, Finished Drug Products, Stability and Microbiology testing. Data Review may include release, raw… more
- Exela Pharma Sciences, LLC (Lenoir, NC)
- …procedures, corporate policies, and the regulatory requirements of the US Food and Drug Administration.Job Responsibilities:Draft and review technical documents ... supporting raw material and/or drug product release and stability with some supervisionPerform calibrations and calibration verificationCompile data to support… more
- Exela Pharma Sciences, LLC (Lenoir, NC)
- …procedures, corporate policies, and the regulatory requirements of the US Food and Drug Administration.Job Responsibilities:Perform analytical testing of samples ... supporting incoming raw materials, in-process production, drug product and stability samples with some supervisionUtilize analytical instrumentation such as FTIR,… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …to Good Clinical Practices (GCPs), appropriate Standard Operating Procedures (SOPs), Food and Drug Administration (FDA) regulations/EU Directive, and ... and liaise with internal Functions within the study team to ensure drug destruction process and other study close out activities are completed. Knowledge… more
- Tris Pharma (Monmouth Junction, NJ)
- …knowledge or skills needed and/or licenses or certificates preferredKnowledge of cGMP, Food and Drug Administration (FDA), Drug Enforcement Administration ... (DEA) and Occupational Safety and Health Administration (OSHA) regulations and guidancesTris Pharma, Inc. offers a highly competitive compensation and benefits package. To build and enhance our diverse workforce, we encourage applications from individuals with… more
- Exela Pharma Sciences, LLC (Lenoir, NC)
- …with local procedures, corporate policies, and the regulatory requirements of the US Food and Drug Administration. The individual will be responsible for ... approves documents to release of components, raw materials and drug products.Provides troubleshooting support as neededPerformance and documentation of laboratory… more
- Aequor (Chattanooga, TN)
- …Standard Operating Procedures (SOP's), Good Manufacturing Practices (GMP) Compliance, and Food and Drug Administration (FDA) regulatory standards. Maintain ... Peer Relationships, Directing Others, and Comfort Around Higher Management o Experience in Food or Pharma manufacturing following FDA regulations is preferred. more
- Exela Pharma Sciences, LLC (Lenoir, NC)
- …local procedures, corporate policies, and the regulatory requirements of the US Food and Drug Administration.Job Responsibilities Oversee and Manage Approved and ... leadership preferred Five (5) years SQE experience in the automotive, pharmaceutical, food or chemical or other cGMP industries required Lean/Six Sigma experience… more
- Exela Pharma Sciences, LLC (Lenoir, NC)
- …procedures, corporate policies, and the regulatory requirements of the US Food and Drug Administration. Job Responsibilities:Enforce/Maintain clean room ... protocols by complying with garbing and behavior requirements that align to established cGMP practices and techniques Enforce/follow Standard Operating Procedures (SOPs), batch records, current Good Manufacturing Practices (cGMP), including Data Integrity and… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …protocol, Good Clinical Practices (GCPs), appropriate Standard Operating Procedures (SOPs), Food and Drug Administration (FDA) regulations/EU Directive, and ... International Conference on Harmonization (ICH) guidelines. Key focus is on providing clinical trial management support to study teams and tracking CRO and other vendor performance against project goals and milestones to monitor and ensure compliance with… more
- Tris Pharma (Monmouth Junction, NJ)
- …knowledge of regulatory and industry standards related to Medical Affairs role including Food and Drug Administration (FDA), Office of Inspector General (OIG), ... Pharmaceutical Researchers and Manufactures of America (PhRMA), etc.)Expertise in pharmaceutical compliance laws, regulations and guidelines related scientific communications, as well as industry best practices related to MSL activitiesExperience leading… more
- Exela Pharma Sciences, LLC (Lenoir, NC)
- …with local procedures, corporate policies, and the regulatory requirements of the US Food and Drug Administration. Job Responsibilities: Comply with garbing and ... behavior requirements that align to established cGMP practices for pharmaceutical finishing activitiesFollow/enforce Standard Operating Procedures (SOPs), batch records, current Good Manufacturing Practices (cGMP), including Data Integrity and Good… more
- Exela Pharma Sciences, LLC (Lenoir, NC)
- …local procedures, corporate policies, and the regulatory requirements of the US Food and Drug Administration. Job Responsibilities:Ensure/adhere to garbing and ... behavior requirements that align to established cGMP practices for pharmaceutical finishing activitiesEnforce/follow Standard Operating Procedures (SOPs), batch records, current Good Manufacturing Practices (cGMP), including Data Integrity and Good… more
- Tris Pharma (Monmouth Junction, NJ)
- …to Standard Operating Procedures (SOPs), current Good Manufacturing Practices (cGMPs) and Food and Drug Administration (FDA) standards. Performs routine and ... complex work related to the troubleshooting, repair, and upgrade of manufacturing equipment; Responsible for the preventive maintenance (PM), repair and continuous improvement of facilities and manufacturing equipment Assists in performing root cause analysis… more
- Exela Pharma Sciences, LLC (Lenoir, NC)
- …procedures, corporate policies, and the regulatory requirements of the US Food and Drug Administration. Job Responsibilities:Maintain clean room environment ... by complying with garbing and behavior requirements that align to established cGMP practices for pharmaceutical manufacturing activitiesFollow Standard Operating Procedures (SOPs), batch records, current Good Manufacturing Practices (cGMP), including Data… more
- Merck & Co. (Rahway, NJ)
- …team is responsible for the research and development of sterile & parenteral drug products for biologics as well as the biopharmaceutics support for the oral ... impactProactively identify key biopharmaceutics risks at each stage of drug product development for small molecules and/or biologics, conducting hypothesis-based… more
- Merck & Co. (South San Francisco, CA)
- …will be working in a multidisciplinary group to identify, validate and advance drug targets for the treatment of CNS regulation of appetite control, neuronal ... in leading projects and shepherding programs through various stages of drug discovery, including - target identification and validation, building a project… more
- Food and Drug Administration (Silver Spring, MD)
- …knowledge of critical organizational issues. Writes and edits assignments related to the Food , Drug , and Cosmetic Act (the Act) and other regulatory authorities. ... at the GS-12 grade level Additional Information For some advertisements, the Food & Drug Administration receives hundreds, even thousands, of applications… more
- Food and Drug Administration (IN)
- …about the products we oversee. Responsibilities These positions are located in the Food and Drug Administration (FDA), Center for Devices and Radiological Heath ... visit the https://sites.ed.gov/international/recognition-of-foreign-qualifications/ Additional Information For some advertisements, the Food & Drug Administration receives hundreds, even… more
- Food and Drug Administration (Jefferson, AR)
- Summary Positions are located in the Food and Drug Administration (FDA), National Center for Toxicological Research (NCTR), Division of Neurotoxicology (DNT). ... the : https://sites.ed.gov/international/recognition-of-foreign-qualifications/ Additional Information For some advertisements, the Food & Drug Administration receives hundreds, even… more
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