- 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
- BioAgilytix (Boston, MA)
- …to the patients who need them.We're seeking a detail-oriented and proactive Corporate Compliance Specialist to join our team. In this role, you'll play a crucial ... part in supporting various Corporate Compliance and Archivist activities. Key responsibilities include serving as...status, religion, age, disability, gender identity, results of genetic testing , service in the military, or any other group… more
- Insmed Incorporated (Bridgewater, NJ)
- …in ensuring oversight and execution of all aspects of commercial GMP related analytical testing , as well as late stage GMP development testing . Responsible for ... timely processing of data produced by internal and contract laboratories and testing performed by manufacturers of all commercial and late stage development… 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. (Plainsboro, NJ)
- …range of expertise of principles, methods, practices, standards, procedures and compliance requirements of a particular business function in designing and developing ... escalate issues to the next level support, collaborate with business teams on testing of issues, etc. Manage incidents, changes and problems in ServiceNow or… more
- Merck & Co. (Rahway, NJ)
- …Analysis, Privacy Compliance , Requirements Management, Team Management, Team Operations, Technical Leadership, Technology Implementations, Testing ... focus on Workday Learning, Microsoft and ServiceNow systems including configuration, testing and/or support.Authors or facilitates the creation of functional or data… more
- Aequor (New Brunswick, NJ)
- …Monitor schedules to ensure timely completion of calibration, performance verification testing , and maintenance services. Ensure calibration testing on ... Oversee vendors during work execution, ensuring adherence to safety and compliance practices. Immediately report any deviations, discrepancies, or safety concerns… 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)
- …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
- 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
- Catalent (San Diego, CA)
- …performance, Operational Excellence, continuous improvement, error reduction, regulatory compliance , and sound fiscal responsibility. The primary responsibilities of ... to the clinic with services that include analytical development, pre-formulation testing , formulation development, GMP manufacturing and stability storage and … 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)
- …variety of activities pertaining to supporting, maintaining, and assuring compliance with quality systems requirements and applicable regulatory requirements; to ... to the clinic with services that include analytical development, pre-formulation testing , formulation development, GMP manufacturing and stability storage and … more
- Insmed Incorporated (Bridgewater, NJ)
- …and procedures. Requires monitoring of the various plans and policies to ensure compliance with legal requirements and company objectives. This is a hands-on role ... payroll deductions and benefits payments. Partner with legal department to ensure compliance with various federal, state, and local leave legislation and mandates.… more
- Catalent (San Diego, CA)
- …to the clinic with services that include analytical development, pre-formulation testing , formulation development, GMP manufacturing and stability storage and ... testing as well as Clinical Supply Services. At Catalent...a Patient First culture through excellence in quality and compliance , and to the safety of every patient, consumer,… 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
- Novo Nordisk Inc. (Plainsboro, NJ)
- …Professional Omnichannel Program Development, Implementation, Promotion and Monitoring: Assure compliance with Novo Nordisk Inc. (NNI) Corporate Visual Identity ... and its waterfall of content Manage project vendor partners, budgets, schedules, testing and quality components Participates on Extended Brand Teams (EBTs) -… more
- Catalent (San Diego, CA)
- …performance liquid chromatography (HPLC/UPLC), UV/Vis spectroscopy, GC, USP dissolution testing apparatus, moisture analysis by Karl Fischer, disintegration, Pion ... udiss, DSC, TGA, PSD, PXRD, SEM, hardness, and friability testing .Troubleshoot and optimize analytical methods for characterization of drug products and… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …collaboration across relevant cross functional groups to enable robust production, testing and release of product to patients. Key Responsibilities Provides ... a Right First Time culture of quality, permanent inspection readiness compliance mindset and passionately drives continuous improvement. Provides technical expertise… more
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