- Repligen (Waltham, MA)
- …Notifications (SCNs)Evaluate and manage Supplier Change Notifications to ensure compliance with internal and regulatory quality standards.Coordinate ... growing Supplier Quality team. You will a key role in ensuring the quality, compliance , and performance of Repligen's global supplier base. This is an opportunity to… more
- Merck & Co. (Rahway, NJ)
- …environment.Responsibilities include but are not limited to: Lead and oversee analytical investigations with a strong focus on quality and regulatory compliance ... as mass spectrometers and other spectroscopic techniques.Collaborate closely with internal company sites and Contract Manufacturing Organizations (CMOs) within the… 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
- 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
- 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
- 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. (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
- 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
- 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
- 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
- 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
- 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
- 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)
- …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
- 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
- Eisai, Inc (Exton, PA)
- …of documentation, manufacture of DS/ADI materials, and suite change-over ensuring compliance to relevant regulations. The Associate Director is also responsible to ... Operations maintains knowledge of established and emerging technologies, utilizes internal and external networks, and leverages prior relevant experience to… more
- L3Harris (Arlington, VA)
- …audits, and other internal monitoring activity as applicable. + Assist with investigations and other compliance matters as needed + Support investigation ... Trade Compliance will focus on managing L3Harris' trade related internal monitoring program while supporting the development and implementation of internal… more
- Penn State Health (Hershey, PA)
- …industry and will be responsible for developing, implementing, and managing regulatory compliance oversight and internal compliance audit across Penn ... to various sites **SUMMARY OF POSITION:** The Director of Compliance and Privacy ( Investigation and Guidance) will...compliant behavior and provides the basis for ensuring adequate internal controls and compliance with all laws… more
- TECO Energy (Ybor City, FL)
- …an expert level knowledge of IT governance frameworks and regulatory, contractual, and internal compliance standards including NERC CIP, SOX , DFARS, DHS, COBIT, ... contractual requirements, and Emera requirements. Primarily responsible for audit readiness, compliance issue investigation and reporting, compliance … more
- Southwest Power Pool (Little Rock, AR)
- …Assist the Compliance Manager and Director with the development and execution of Internal Compliance Program (ICP) initiatives + Act as a liaison between the ... serve as a consultative subject matter expert when needed + Mentor and guide junior compliance staff on regulatory responsibilities and internal processes +… more
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