- Novo Nordisk Inc. (Plainsboro, NJ)
- …and provides and incorporates into new and existing processes Responsible for managing compliance and audit documentation for Talent Acquisition Ensures process ... activities in support of the function Responsible for partnering with legal, compliance and employee relations on requests for information Performs audits of… more
- Merck & Co. (Rahway, NJ)
- …experience to support facility operations, process development activities, compliance investigations/change management, and authoring of GMP documentation ... design and testing as well as preparation, review, and completion of GMP documentation .Support compliance with Industrial Hygiene (IH) program by leading or… more
- Merck & Co. (Rahway, NJ)
- …experience to support facility operations, process development activities, compliance investigations/change management, authoring of GMP documentation , ... testing as well as preparation, review, and completion of GMP documentation . Support compliance with Industrial Hygiene (IH) program by leading or participating… more
- Aequor (Davie, FL)
- …and execution of maintenance activities. PLC experience or certification a plus GMP Compliance related documentation a plus Project management experience a plus. ... Skills/Knowledge/Abilities: Knowledge and ability to troubleshoot hardware and software used on purified water systems. Reading and ability to interpret blueprints and schematics. Communicating clearly and concisely, both orally and in writing. Management… more
- Lovelace Biomedical Research Institute (Albuquerque, NM)
- …of expertise. The work is performed in a highly regulated environment and compliance with documentation standards is required, will perform all other related ... duties and tasks as required or assigned. QualificationsBachelor's degree in a scientific area or with comparable course work and a minimum of 5 years of relevant work experience; or an equivalent combination of education, training and/or experience from which… more
- Merck & Co. (Rahway, NJ)
- …include but are not limited to:Manage US Department of Agriculture (USDA) compliance issues raised by Import Specialists and shippers, including questions and issues ... Post Summary Correction (PSC) requests to brokers, including maintaining required documentation in our Company systems of recordPerform monthly Post Entry Review… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …of materials prior to dissemination.Assists OEDC leadership with timely submission and compliance of all required DS documentation for quality control/assurance, ... acts as a "change agent" within DS to ensure compliance and alignment with DS highest standards. This position...solutions.Acts as a change agent within DS to ensure compliance and alignment with DS highest standards. Uses quality… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …technology strategies to identify, track, store, and disseminate critical CMR training documentation Ensures training and compliance to FDA Regulations, ICH ... CMR employee on-boarding, cultural engagement, technical/role-specific training and GxP/Regulatory compliance across CMR functions. Position will serve as an… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …tracking of labeling milestones. Collaborate with Global Labeling Operations and Compliance leads to product high quality labeling documentation .Establishes ... tracking of labeling milestones. Collaborates with Global Labeling Operations and Compliance Leads to produce high quality labeling documentation .Establishes… more
- Merck & Co. (Durham, NC)
- …uses this knowledge in own workUnderstands and applies regulatory/ compliance requirements relative to their roleInfluence, motivate, and energize individuals ... will be responsible for activities that support cGMP and regulatory compliance during method qualification/validation and routine product testing to include the… more
- Aequor (Salt Lake City, UT)
- …issues on the manufacturing/packaging floor and during batch record documentation /review. 6. Investigations and Recommendations: Participate in investigations and ... revise, and review SOPs, forms, and work instructions for accuracy and GMP compliance . 8. Additional Duties: Perform other related tasks as assigned. Skills and… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …tracking of labeling milestones. Collaborate with Global Labeling Operations and Compliance leads to product high quality labeling documentation .Establishes ... of country labeling deviations for assigned Daiichi Sankyo products ensuring compliance with all applicable Health Authority (HA) regulations and guidelines,… more
- Exela Pharma Sciences, LLC (Lenoir, NC)
- …associated documentation in support of producing pharmaceutical products in compliance with all safety policies, cGMPs, and SOPs. This position supports the ... ongoing development, manufacture, and distribution of pharmaceutical products in compliance with local procedures, corporate policies, and the regulatory… more
- Exela Pharma Sciences, LLC (Lenoir, NC)
- …of associated activities and ensuring accurate and timely completion of associated documentation in support of pharmaceutical production in compliance with all ... The SQE Manager, QA Compliance , is responsible for managing the Supplier Quality...Good Manufacturing Practices (cGMP), including Data Integrity and Good Documentation Practices (GDocP) Support Supplier Quality Team with coordination… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …tracking of labeling milestones. Collaborates with Global Labeling Operations and Compliance Leads to produce high quality labeling documentation .Establishes ... EU. Preparation of updated Core Data Sheets, and EU and US Documentation : Independently manages, prepares and implements regulatory documents (eg, USPI, annotated… more
- Merck & Co. (Durham, NC)
- …uses this knowledge in own workUnderstands and applies regulatory/ compliance requirements relative to their roleInfluence, motivate, and energize individuals ... be responsible for activities that support cGMP and regulatory compliance during facility design, construction, start-up method transfer/validation activities and… more
- Exela Pharma Sciences, LLC (Lenoir, NC)
- …associated documentation in support of producing pharmaceutical products in compliance with all safety policies, cGMPs, and SOPs. Supervisors will drive employee ... ongoing development, manufacture, and distribution of pharmaceutical products in compliance with local procedures, corporate policies, and the regulatory… more
- Exela Pharma Sciences, LLC (Lenoir, NC)
- …of the drug development processes within ExelaGain familiarity with the documentation and data associated with manufacture of products (compounding, QC analytical ... that will be submitted to FDA as per the business needs and compliance with all FDA requirementsReviews change controls for regulatory impact and documentation… more
- Merck & Co. (Durham, NC)
- …support for commercial analytical assays (UPLC, Solo VPE) Author technical documentation associated with the development and implementation of assays for product ... reports and risk assessments Author or approve Change Control documentation for complex process, validation, analytical, equipment, facility/utility and/or… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …as PV Operations SPOC for study teams to ensure consistency and compliance across clinical study safety reporting and activities.Global Management Strategy and Goals ... and Procedure Development: Assist Leadership to ensure compliance with protocol and internal/external standards. Identifies and drives strategy for process… more
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