- 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
- 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
- Novo Nordisk Inc. (Plainsboro, NJ)
- …broad range of expertise of principles, methods, practices, standards, procedures and compliance requirements of the business function in designing and developing IT ... In the support role of existing systems, this role provides knowledge, testing , documentation, Service Level management reporting. This role will liaison with… 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. (Millsboro, DE)
- …at our company's Millsboro Animal Health facilities. This role is highly compliance -driven in accordance with State and Federal regulations as applicable to the ... / ResponsibilitiesAssociate Director: Lead and develop a team of animal care and testing specialists.Serve as a member of the Senior Leadership Team for the… 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. (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
- 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
- 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
- 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
- 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
- Merck & Co. (South San Francisco, CA)
- …Integrates EHS programs into daily operations to assure regulatory compliance , achieves continuous performance improvement, meeting EHS performance objectives. ... site's recordkeeping and completion of regulatory submissions/notifications to maintain compliance with federal, state, and local regulation.EHS Program support,… 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
- 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
- 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)
- …non-compendial methods with support of additional activities related to the testing of pre-capsulation, Stability and Finished Products as required. The Scientist ... interacts with clients to provide not only research and testing of products, but also support CMC development activities...a Patient First culture through excellence in quality and compliance , and to the safety of every patient, consumer… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …and Reimbursement (PCOR) Account Management, the SME for Medical Review Committee, Compliance , Legal, Personal Promotion, and other HCP related policies. The role ... Management, Market Access, all Field Sales teams, Omni Channel, Legal and Compliance . External relationships will include other NNI stakeholders and external vendors… more
- Merck & Co. (North Wales, PA)
- …with partner groups in critical review of submissions to ensure compliance , scientific excellence, accuracy and completeness of submissions.Resolve complex project ... biologics products worldwide.Conduct all activities with an unwavering focus on compliance .May need to manage or mentor junior team members.-Technical Skills:Proven… more
