- 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. (Durham, NC)
- …vaccine capital projects Provide deep SME knowledge for manufacturing investigations support (Product and process deviations and complex material-related) ... Collaborate with internal /external partners, eg Our Company sites, Procurement, Raw Material & Component Suppliers Develop effective data analytics methodologies,… 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)
- …process characterization, control strategy development, technology transfer to internal and external manufacturing sites, manufacturing investigations , ... in Biologics Cell Culture Sciences group and working in conjunction with internal and external partners, this individual will support late stage and commercial… 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
- 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
- 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
- Essen Medical Associates (Bronx, NY)
- … compliance issues and related opportunities for process improvements. Perform internal compliance investigations and audits throughout the organization, ... understanding of the healthcare regulatory industry, with experience in conducting complex compliance investigations . Must have the ability to carry out… 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
- Repligen (Hopkinton, IA)
- …Non-Conforming Material.Reject any non-conforming material and support Root Cause Investigations .Good organization skills and Microsoft Office software to accurately ... continuous improvement opportunities for the quality program for customers internal and external.Maintain clean and orderly work area/ station.Comply with… 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
- Bumble Bee Seafoods (San Diego, CA)
- … compliance policies and procedures to mitigate legal risks and maintain regulatory compliance . Lead internal investigations related to compliance ... Job Type Full-time Description Purpose Job Overview: As Corporate Counsel & Compliance , you will play a pivotal role in ensuring that the company adheres to… more
- OKX (San Jose, CA)
- …a friendly, rewarding, and diverse environment for every OK-er. About the Team The Compliance function at OKX is responsible for the overall compliance culture ... The successful candidates will have prior AML transaction monitoring and investigations experience in the financial services, FinTech or cryptocurrency industries.… 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
- Smithfield Foods, Inc. (Wichita, KS)
- …with other departments on production issues/situations, product dispositions and investigations into root causes for deficiencies. Assists in managing quality ... claims and keep quality to specifications through accurate inspections, non- compliance procedures, appropriate reporting, corrective actions and accuracy of… more
- Holland & Knight LLP (Tampa, FL)
- …in any of our US offices. General Description: We are seeking a Privacy and Compliance Analyst to join our team. The Privacy and Compliance Analyst will support ... an understanding and experience with data protection and privacy laws, compliance functions, clients and third-party risk assessments, and research evaluation. Key… more
