- Merck & Co. (Durham, NC)
- …Notification authoring and provide audit support. GENERAL PROFILE: Collaborate with internal customers and vendors to identify, evaluate, and implement new ... timelines and budgeting.Build knowledge of the company, processes, and internal /external customersBuild and maintain strong relationships with site leadership,… more
- Tris Pharma (Monmouth Junction, NJ)
- …projects regularly reporting status/issues to management, conducts laboratory investigations and recommends appropriate Corrective Action Preventive Action ... studies to support MV, method transfer and complex technical investigations and assists and trains lower level scientists.Responsibilities:Carries out… more
- Repligen (Waltham, MA)
- …Chromatography & Proteins.ResponsibilitiesThe Director, Quality will be responsible for:Maintaining site compliance to ISO 9001 for all aspects of the QMS including ... but not limited to Internal and External Auditing, Nonconforming Materials, CAPA, Validation, Change...host for site auditsMaintain risk-based strategy for overall Quality compliance across the organization and in support of the… more
- Merck & Co. (Rahway, NJ)
- …Analytical Research & Development (AR&D) External Capabilities, Validation, and Compliance (ECVC) department of our company's Research Laboratories Division is ... role will include:Partner with scientific teams across AR&D to drive compliance and operational excellence Onboard, qualify, and maintain laboratory equipment and… more
- Merck & Co. (Rahway, NJ)
- …as new drug applications, clinical study reports, or publication; andParticipation in internal and joint internal /external research project teams relevant to the ... of the progress of studies of our companies and competitors' drugs and internal and external expert opinion on scientific questions relevant to his/her areas of… more
- Tris Pharma (Monmouth Junction, NJ)
- …product development and analytical method development and supports laboratory investigations and performance of non-routine testing such as method comparisons ... as needed Cleans, maintains and calibrates laboratory instruments to ensure compliance with current Good Laboratory Practices (cGLPs) and Good Manufacturing… more
- Merck & Co. (Rahway, NJ)
- …environment that provides substantial technical responsibility and leadership of internal and external work.The Senior Scientist, Engineering position leverages ... scales.The successful candidate will play a pivotal role in developing internal technical capabilities via mentoring junior staff and enhancing fermentation and… more
- Eisai, Inc (Raleigh, NC)
- …The QA Specialist plays a critical role in ensuring the quality and compliance of commercial and clinical products manufactured at the Eisai Raleigh facility. This ... quality assurance functions, supporting regulatory inspections, and collaborating with internal and external stakeholders to resolve quality-related issues.Key responsibilities… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …first time), schedule adherence, and productivity improvements.Support manufacturing investigations , support and manage change controls, and maintain permanent ... the delegate for the Head of Operations.Establish key stakeholder relationships with internal and external stakeholders. Ability to interact with all levels within… more
- Merck & Co. (Rahway, NJ)
- …Driving License:Hazardous Material(s):Required Skills:Business, Business, Compliance Investigations , Confidentiality, Cross-Cultural ... the US and globally to execute efficiently on regulatory obligations, compliance requirements and company strategy.Providing quality advice to stakeholders creating… more
- AUROBINDO (Durham, NC)
- …internal workshops or sourcing external training providers.Additional ResponsibilitiesEnsure compliance with company policies and federal, state, and local ... training, on-boarding, orientation, policy implementation, compensation, and employment law compliance .Manage and conduct the new hire orientation and exit interview… more
- Merck & Co. (Rahway, NJ)
- …in interpreting trends from commercial process monitoring, driving further investigations and process improvements that elevate our standards.Engage Across ... Functions: Actively interact with internal and external partners, representing your functional area on...applicants with arrest and conviction records for employment in compliance with the San Francisco Fair Chance Ordinance Los… more
- Merck & Co. (Durham, NC)
- …establishing a strong business partnership and ensuring excellence in Compliance , Supply, Continuous Improvement, and Cost Management.--The Associate Director, ... Resolution (with appropriate escalation as required). Resolve Technical Issues ( Investigations , CAPAs, Process Improvements, Source Changes, Technical Transfers, Equipment… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …alignment to Global Procedures.Act as a Site MES SME to support Quality Investigations , Corrections, and QMS records.Build the Site Readiness of MES for FDA and/or ... assesses updates and impact.Key Relationships: establish key stakeholder relationships with internal and external stakeholders. Ability to interact with all levels… more
- Ensign Services (Santa Ana, CA)
- …the skilled nursing environment. Primary responsibilities will involve performing clinical compliance audits, conducting internal investigations under ... to develop a corrective action plan to resolve the same Conducts internal investigations involving general compliance and clinical issues under the direction… more
- TD Bank Group (Mount Laurel, NJ)
- …the ability to lead, train and mentor teams in conducting thorough investigations , ensuring regulatory compliance , and maintaining high standards of accuracy. ... may include HR, Technology, Finance, Risk Management Ensures team operates in compliance with applicable internal and external requirements, and employees comply… more
- Cipla (Central Islip, NY)
- …of Cipla's US Subsidiaries or Affiliates. Job Title QMS Lead - Investigations Organization Name InvaGen Pharmaceuticals, Inc. Location Central Islip, NY Employment ... Accountabilities Lead of investigation team and involve in conducting thorough investigations related to Out of Specifications (OOS), Out of Trend (OOT),… more
- Miltenyi Biotec (San Diego, CA)
- …small-team environment, the Healthcare Compliance Officer will also oversee internal investigations , support training and monitoring activities, and serve as ... compliance with applicable state and federal reporting obligations. Internal Investigations , Auditing, and Risk Management Lead...and Risk Management Lead or support internal investigations related to code of conduct or compliance… more
- Warner Bros. Discovery (Washington, DC)
- …candidate will collaborate with reporters and producers to shape impactful investigations , manage multiple projects under tight deadlines, and help translate complex ... tools. Must have experience with FOIA process. Help translate complex investigations into clear, visual narratives - working with animators, motion designers,… more
- May Institute (Randolph, MA)
- …across departments to meet enrollment goals and deliver high-quality programming *Coordinate internal investigations and licensing compliance with state ... agencies (DESE, DCF, DEEC, DDS, DPPC) alongside HR and general counsel *Monitor satisfaction across parents, staff, districts, and students through formal feedback and engagement initiatives *Assist in strategic planning by identifying organizational barriers… more
