- Merck & Co. (Rahway, NJ)
- …operational experience to support facility operations, process development activities, compliance investigations /change management, and authoring of GMP ... drug substance and/or biologics process development and scale-up Experience supporting compliance investigations and change management. Experience working with… more
- Merck & Co. (Rahway, NJ)
- …experience to support facility operations, process development activities, compliance investigations /change management, authoring of GMP documentation, ... pertains to small molecule drug substance and/or biologics- Experience supporting compliance investigations and change management. Experience working with… more
- Merck & Co. (Rahway, NJ)
- …inspections.Address audit findings and identify trends to enhance laboratory compliance .Conduct laboratory investigations and collaborate with stakeholders to ... a driven leader to advance and commercialize complex biotherapeutics.The Director of Compliance , reporting to the Senior Director of GMP Operations, will oversee… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …areas centered around rare diseases and immune disorders. We are currently seeking a Compliance Intern for the year (June 2025 - May 2026). This part time position ... works for approximately 20 hours per week. Responsibilities: The Compliance Intern will provide support to the Policy, Training and Communications team and the… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …cross-functional environment to complete tasks required to meet business objectives.Support Investigations team by providing quality and compliance input for ... responsible for quality and maintaining the highest standards in compliance within company policies, procedures, and all applicable regulations.Key Responsibilities… more
- Merck & Co. (North Wales, PA)
- …technology transfer to internal and external manufacturing sites, manufacturing investigations , process validation, and authoring of regulatory submissions. - - ... analysis to assess processing requests. Support tech transfers, process investigations , study design, and on-the-floor manufacturing support. Drive organizational… 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
- Merck & Co. (Rahway, NJ)
- …technology transfer to internal and external manufacturing sites, manufacturing investigations , process validation, and authoring of regulatory submissions. -Under ... For commercial programs, activities include site-to-site process transfers, manufacturing investigations and trend evaluations, process enhancements, next generation process… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …members to ensure that the organization is in a perpetual state of compliance as follows:Support the Global Quality Lead(s) (GQLs) and Regional Quality Leads (RQLs), ... the status of Quality Events (QEs), CAPAs and GCP compliance matters raised to the GQLs and/or RQLs from...Actions (CAPAs) related to GCP audits. Participate in formal investigations of quality events (QEs) as they arise, in… 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
- Merck & Co. (Durham, NC)
- …technical documents, standard operating procedures, change controls, and investigations for the performance of laboratory methodsTrouble-shoot analytical process ... during audits and inspections (regulatory, internal, safety)Collaborate with site compliance team to ensure adherence to regulatory requirementsReview and approve… more
- Exela Pharma Sciences, LLC (Lenoir, NC)
- The SQE Manager, QA Compliance , is responsible for managing the Supplier Quality Program at Exela ensuring timely completion of associated activities and ensuring ... and timely completion of associated documentation in support of pharmaceutical production in compliance with all CFR, USP, cGMPs, and SOPs. SQE Manager, QA … more
- Merck & Co. (North Wales, PA)
- …company's productsBuild and manage relationships with vendors who will perform benefits investigations and other related support to help ensure that patients and ... Patient Access COEWork closely with legal and regulatory departments to ensure compliance with internal and external rules for all programs.Exhibit ownership and… more
- Exela Pharma Sciences, LLC (Lenoir, NC)
- …ongoing development, manufacture, and distribution of pharmaceutical products in compliance with local procedures, corporate policies, and the regulatory ... these techniquesPerform instrument troubleshooting and preventive maintenance as neededPerform investigations on studies that have unusual results, and on… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …systemsPerform on-site equipment maintenance and critical utilities maintenance operations, and compliance . This includes but is not limited to: support to ... business operations.Support facility project initiatives as neededMaintain knowledge of and compliance to all applicable codes and regulations as required. Obtains… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …Serves as SME on engineering design projects; sets project requirements, evaluates compliance with project and engineering standards, and approves final designs and ... other job plans within the CMMS for effectiveness, applicability, and compliance . Ensure all equipment is operated and maintained within a… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …failures (increasing availability), but also on increasing EHS & QUALITY compliance or reducing costs (without reducing availability). He/she monitors the proper ... failures (increasing availability), but also on increasing EHS & QUALITY compliance or reducing costs (without reducing availability). He/she monitors the proper… more
- Merck & Co. (Durham, NC)
- …recordsTrouble-shoots equipment issues as neededInitiates and contributes to laboratory investigations as needed and follows site procedures in the documentation ... of Quality Notifications and Preventative ActionsCollaborates with Durham Laboratory Compliance to ensure adherence to regulatory requirementsProvides active support… more
- Exela Pharma Sciences, LLC (Lenoir, NC)
- …oversight and administrative support while supporting production objectives in compliance with all safety procedures, cGMPs, and SOPs. Responsibilities Maintain ... compliance with cGMP, safety standards and good housekeeping standardsAssist Operations Manager in supervising daily operations Determine staffing requirements, work… more
- Merck & Co. (Rahway, NJ)
- …will be expected to exhibit a mindset of safety and quality compliance , which will include following current Good Manufacturing Practices (cGMPs), and participating ... in risk assessments, deviation investigations , and Good Documentation Practices (GDPs).-A high level of...applicants with arrest and conviction records for employment in compliance with the San Francisco Fair Chance Ordinance Los… more
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