- Eisai, Inc (Nutley, NJ)
- …compliance risks using a risk assessment framework.Oversee documentation, implementation, and testing of IT compliance controls.Monitor IT compliance ... want to hear from you. Job Summary: As the Americas IT Security and Compliance Director, you play a pivotal role in ensuring the organization's adherence to… more
- Exela Pharma Sciences, LLC (Lenoir, NC)
- …FDA, GLP, QSR, cGMP, USP, and CDR rules, and guidelines), and ensure compliance with testing SOPs and specifications.Participate in proactive functions that ... and workflow for the laboratory personnel. Additionally, you will implement testing standards, policies and ensure safety measures are followed. The supervisor… more
- Novo Nordisk Inc. (West Lebanon, IN)
- …schedule and lead day-to-day QC Microbiology activities for routine in-process and product testing ensuring compliance , accuracy and timeliness of testing ... methods and techniques for obtaining solutions, while maintaining a high level of compliance with cGMP. This position is based onsite at our West Lebanon, NH… more
- Atrium Health (Charlotte, NC)
- … Plan as evidenced by timely participation in required training (including annual testing ) and 100% compliance with the Corporate Compliance Code ... Complies with all required employee health programs including annual tuberculin testing and other applicable screening, testing and vaccinations. Credentials:… more
- Tris Pharma (Monmouth Junction, NJ)
- …meet project timelines. Supports laboratory investigations and performance of non-routine testing such as method comparisons and evaluations. Tracks and maintains ... policies and current industry standards.Essential Job Functions: Carries out responsibilities in compliance with all cGMP, FDA, DEA, and OSHA regulations, as well as… more
- Novo Nordisk Inc. (West Lebanon, IN)
- …strict adherence to cGMPs, established manufacturing practices and procedures, and compliance with quality regulations and guidelines. This position carries out ... routine QC testing and may support sampling, investigations, validations, projects and other related support activities for the manufacturing facility and process.… more
- Aequor (Willow Island, WV)
- …(MFA) business of in Willow Island, WV. The Quality Control laboratory provides testing and release support for the Willow Island manufacturing site. The preferred ... described below. POSITION RESPONSIBILITIES: Receives and prepares samples for analytical testing and initiation of stability studies. Performs physical testing … more
- Merck & Co. (Durham, NC)
- …(PLC), robotics)- Clean-In-Place (CIP) Systems- Maintenance Equipment (eg tools and testing equipment)- Ability to work with and troubleshoot complex process systems ... inspection, and adjustments to process equipment as needed Installation, testing , adjustment, maintenance, repair, and troubleshooting of complex automated process… more
- Merck & Co. (Durham, NC)
- …inspection, and adjustments to process equipment as needed.Installation, testing , adjustment, maintenance, repair, calibration and troubleshooting of complex ... maintenance (PM) plans/calibration procedures, task lists, etc., as required.Work compliance systems for maintaining PM program and assessing equipment -… more
- Aequor (West Greenwich, RI)
- …to 5PM, 10 hour shift schedule No opportunity for remote work as sampling and testing will be done in the labs for this role. General lab experience/lab background, ... position will be responsible for activities including microbiology & analytical testing , sample and data management and equipment and instrumentation operation and… more
- Catalent (St. Petersburg, FL)
- …is committed to a Patient First culture through excellence in quality and compliance , and to the safety of every patient, consumer and Catalent employee. The ... Role Responsible for conducting pre-formulation, formulation preparation, testing and analysis work in the PD lab. Schedule and conduct lab work to ensure timely… more
- Novo Nordisk Inc. (West Lebanon, IN)
- …Manufacturing and QC for the coordination of process/equipment improvements, sample testing and data trending/analysis Review of completed QC documentation Ability ... Revise documentation (SOP, forms, reports, notebooks) associated with the testing of in-process/product samples, requiring some direction Incorporate pre-planned… more
- Catalent (San Diego, CA)
- …applicable GMPs. This individual will be responsible for evaluating the compliance of documents such as batch records, equipment records, environmental monitoring ... to the clinic with services that include analytical development, pre-formulation testing , formulation development, GMP manufacturing and stability storage and … more
- Catalent (St. Petersburg, FL)
- …Associate Scientist I, Analytical Research & Development supports evaluation and testing of raw materials, excipients, APIs, in-process, and finished product ... is committed to a Patient First culture through excellence in quality and compliance , and to the safety of every patient, consumer and Catalent employee.The… more
- Merck & Co. (Rahway, NJ)
- …to lead and support facility operations, process development activities, compliance investigations/change management, authoring of GMP documentation, and lead other ... initiatives as appropriate. Collaborate closely with development engineers & chemists, compliance representatives, and other team members to ensure the quality and… more
- Fannie Mae (Washington, DC)
- …statistical learning and econometric models, ensuring all models are in compliance with enterprise governance controls and enterprise risk management requirements. ... including their business context, theoretical framework, methodology, statistical and performance testing , and other topics. Serve as a bridge between the… more
- Merck & Co. (North Wales, PA)
- …Director Quality Engineering & Quality Assurance is responsible for independent compliance support of Medical Devices including the device constituent part of ... filings and audits of data, policies, procedures, and systems to ensure compliance with Medical Device (21CFR 820s) and Combination Product current Good… more
- BioAgilytix (Durham, NC)
- …or unique issues and challenges regarding registration and compliance activitiesReviews, interprets, and communicates FDA/international regulations and guidance ... of change, supplemental submission)Advise on impact of regulations, devises strategies for compliance and acts as liaison with regulatory bodies and sponsors for… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …experience working in an aseptic manufacturing facility, preferably cell therapy, testing facility, quality assurance, or manufacturing compliance Knowledge of ... to establish a strong, compliant CQV program to enable robust production, testing and release of product to patients. Key Responsibilities Executes the… more
- Merck & Co. (Rahway, NJ)
- …two areas.Work with process development teams on technical development and the testing of new technologies, trialing new automation strategies, and implementing them ... production. -Execute and develop appropriate system validation, change control, and testing documentation in partnership with project CQV and IT teams.Establish GxP… more
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