- Tris Pharma (Monmouth Junction, NJ)
- …throughout the organization. Ensures compliance with all current GxPs, Food and Drug Administration ( FDA ), Drug Enforcement Administration ... sourcing, contract negotiation, and supplier management Strong knowledge of FDA regulations, current Good Manufacturing Practices (cGMPs) and pharmaceutical supply… more
- Tris Pharma (Monmouth Junction, NJ)
- …Operating Procedures (SOPs), current Good Manufacturing Practices (cGMPs), Food and Drug Administration ( FDA ) standards and batch record specifications. ... assists in the packaging of pharmaceutical products according to SOPs, cGMPs, FDA standards and batch record specifications Performs the day-to-day activities of the… more
- Tris Pharma (Monmouth Junction, NJ)
- …and/or licenses or certificates preferred: Experience working with Food and Drug Administration ( FDA ), current Good Laboratory Practices (cGLPs), cGMPs, ... SOPs and regulatory rules, regulations and guidelines Proficiency with Empower software Ability and/or experience training and mentoring lower level chemists Experience with wet chemistry and chemistry related to sampling methods, quality control systems,… more
- Tris Pharma (Monmouth Junction, NJ)
- …Operating Procedures (SOPs), current Good Manufacturing Practices (cGMPs), Food and Drug Administration ( FDA ) standards and batch record specifications. ... The incumbent creates and tracks work orders, assists in resolution of material shortages, material transfer and replenishment strategy execution ensuring product availability while minimizing excess inventory.Carries out responsibilities in accordance with… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …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 Daiichi Sankyo… more
- Cipla (Hauppauge, NY)
- …Practices (cGMP), Packaging Area Standard Operating Procedures and Food and Drug Administration ( FDA ) regulations Ability to communicate effectively and ... clearly, both written and verbally in English. Comply with safety and quality regulatory standards when packaging products.Ensure products are packaged in accordance with packaging time standards. Flexible and Adaptable: Copes with ambiguity, change and… more
- Integra LifeSciences (Plainsboro, NJ)
- …thorough understanding of the following regulations and guidelines: US Food and Drug Administration ( FDA ) regulations, ISO 9001, ISO 13485, Medical ... distribution of medical products is in compliance with corporate policies, US Food and Drug Administration regulations, ISO 9001, ISO 13485, the Medical… more
- Arvinas (New Haven, CT)
- …KRAS G12D mutations. On August 8 th 2025, the US Food and Drug Administration ( FDA ) accepted the New Drug Application (NDA) for vepdegestrant- an ... detailed knowledge of the activities and procedures involved in clinical drug development. The Clinical Scientist will collaborate with Clinical Operations,… more
- Parexel (Little Rock, AR)
- …**Skills:** + Extensive knowledge of clinical trial methodologies, ICH/GCP, Food and Drug Administration ( FDA ) and local country regulations + Monitoring ... adverse events (AEs) and serious adverse events (SAEs) and collaborate with the Drug Safety Unit and follow-up with investigators sites, as needed, to bring SAE… more
- Luke Staffing (Portsmouth, VA)
- …to include screening tests and other tests cleared by the Food and Drug Administration ( FDA ). + Prepare specimens for transport in accordance with ... Medical Treatment Facility (MTF) policy. + Perform precise and accurate laboratory testing according to established laboratory procedures. + Participate in peer review and performance improvement activities. + Practice aseptic techniques as necessary. Comply… more
- Sun Pharmaceuticals, Inc (Princeton, NJ)
- …+ Follow ISO, current Good Manufacturing Practices (cGMP), and Food and Drug Administration ( FDA ) procedures + Maintain accurate records of Finished ... and Raw Material Inventory + Package product for shipping + Publish Finished Goods Inventory reports + Assist with loading or unloading materials/packages + Operate forklift and other equipment with strong attentiveness to safety requirements + Perform… more
- Olympus Corporation of the Americas (Westborough, MA)
- …and Usability Engineering to Medical Devices Guidance for Industry and Food and Drug Administration Staff ', the FDA 2022 Guidance, 'Content of Human ... in Medical Device Marketing Submissions Draft Guidance for Industry and Food and Drug Administration Staff', Quality System Regulation (QSR), ISO 13485,… more
- Integra LifeSciences (Princeton, NJ)
- …manufacture, and distribution of medical devices in compliance with corporate policies, US Food and Drug Administration regulations, ISO 13485, the Canadian ... strategies for document and record control, change management, and training administration program. The position is also responsible for assessing, developing and… more
- Eisai, Inc (Cincinnati, OH)
- …laws and regulations impacting the pharmaceutical industry (eg, PhRMA Code; Federal Food , Drug , Cosmetic Act; Anti-Kickback Statute; False Claims Act, OIG/DOJ ... learn about the efficacy and safety of Eisai's product(s) consistent with FDA approved label. Works with office management to provide various informational… more
- Integra LifeSciences (Braintree, MA)
- …components, manufactured sub-assemblies and final product. Must have working knowledge of US Food and Drug Administration regulations, ISO 13485, and other ... studies. + Assist in preparing for and participating in FDA audits, customer audits, etc. + All other duties...regulated product preferred environment. + Familiarity with application of FDA and/or ISO quality standards in a government regulated… more
- Integra LifeSciences (Braintree, MA)
- …components, manufactured sub-assemblies and final product. Must have working knowledge of US Food and Drug Administration regulations, ISO 13485, and other ... (CAPAs). + Assist in preparing for and participating in FDA audits, customer audits, etc. + All other duties...regulated product preferred environment. + Familiarity with application of FDA and/or ISO quality standards in a government regulated… more
- PRIDE Industries (Roseville, CA)
- …California Health and Safety Code, Division 104, Part 5 - Sherman Food , Drug and Cosmetic Law: 2008, and FDA 's Quality System Regulations, preferred; - ... in a supervisory position; - Knowledge and training in Food Safety (HACCP) and Food Protection programs,...at the same time. **EDUCATION REQUIREMENTS:** Bachelors in Business Administration or related field A comparable combination of formal… more
- Integra LifeSciences (Plainsboro, NJ)
- …warehouse associate will perform all required duties in compliance with company policies, US Food and Drug Administration and DOT/IATA, ISO 13485, and other ... skill + Must possess a team focused attitude + Demonstrated knowledge of FDA regulations, ISO 9001, ISO 13485, preferred + Demonstrated computer skills (MS Office,… more
- Integra LifeSciences (Plainsboro, NJ)
- …warehouse associate will perform all required duties in compliance with company policies, US Food and Drug Administration and DOT/IATA, ISO 13485, and other ... skill + Must possess a team focused attitude + Demonstrated knowledge of FDA regulations, ISO 9001, ISO 13485, preferred + Demonstrated computer skills (MS Office,… more
- General Dynamics Information Technology (Silver Spring, MD)
- …Business Requirements Analyst** for new contract to support the ** Food and Drug Administration ( FDA )** and their critical mission needs. As a ... our clients. Current or past experience working at the FDA in a similar capacity is required.** **This is...at the GDIT office in Gaithersburg, MD and/or the FDA office in Silver Spring, MD.** **Responsibilities:** + Assists… more
