- Aequor (Thousand Oaks, CA)
- …remote role Summary: Under general direction, functions as the Specialist Quality Control working at the Corporate QC Center. Description: Job Details: Under general ... NC/CAPA/CC) and process improvements projects to support Corporate Quality Control . Specific responsibilities include performing investigations to support corrective… more
- Repligen (Waltham, MA)
- …an effective internal control framework that spans all global operations. Lead the SOX compliance program, including risk assessments, documentation, testing, ... the SOX program. Shape and execute compliance strategy across a global company Lead SOX risk assessments, audits, and remediation efforts Partner with senior… more
- Merck & Co. (Rahway, NJ)
- …execution, analysis, and documentation of cell culture process commercialization Drive risk assessments, control strategies, comparability reports, PPQ, and ... Job Description Lead the Future of Biologics Drug Substance Commercialization!...improvement initiatives and leverage networks to drive change Enhance data monitoring capabilities and manufacturing robustness Collaborate with colleagues… more
- Merck & Co. (Rahway, NJ)
- …and documentation of all stages of cell culture process commercialization. Risk assessment, control strategies, process comparability reports, Process ... Reporting directly to the Biologics Drug Substance Commercialization Leader, you will lead the Cell Banking working groups and drive innovation in biologics DS… more
- Merck & Co. (Durham, NC)
- …goals through a risk -based approach (Safety Regulations, Quality Assurance, Risk Management, Deviation Management, Product Release, Change Control ).- Supply ... Primary Responsibilities and Activities include but are not limited to : Lead an Integrated Cross-Functional Team in Delivery of Reliable and Compliant Supply:… more
- Merck & Co. (Rahway, NJ)
- …to customers both internal and external to GCS and serves as the lead GCS spokesperson at clinical and development related meetings.- Working independently, the ... not limited to:--Interacts closely with key partner organizations (as a lead GCS Planning program representative) such as clinical development, regulatory, quality… more
- Merck & Co. (Rahway, NJ)
- …analysis, and documentation of all stages of cell culture process commercialization. Risk assessment, control strategies, process comparability reports, Process ... and technical leader with expertise in cell culture development & commercialization to lead a team of approximately 3-5 scientists, who lead multidisciplinary… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …strategy, focusing on every touchpoint that impacts our customers. We leverage data and insights to inform our decision-making processes, ensuring that our ... across clinical, commercial, and enterprise domains. This role involves applying data interpretation and trend forecasting to identify market trends, leading a… more
- Merck & Co. (Durham, NC)
- …and customer service-oriented leader to support the VMF IPT. Will lead the tactical and strategic equipment reliability improvements, human resources activities ... -Responsible for major equipment related projects, including funding, change control and equipment qualification within their areaResponsible for obtaining bids,… more
- Novo Nordisk Inc. (Durham, NC)
- …regulatory requirements computer system, such as 21 CFR Part 11, GAMP5, ISO, Data Integrity preferred Experience with Risk Assessment & Vendor Assessments ... shop floor Ability to support all processes & functions in Department Quality Risk Management Make decisions on quality & compliance issues with little guidance… more
