- 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
- 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
- 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
- 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 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
- 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
- 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
