- Merck & Co. (Rahway, NJ)
- …of medical device and combination product regulations, manufacturing processes, and quality control .Proficiency in advanced statistical methods, such as partial ... and processes.- It is expected that this role will lead significant investigations or events directly, and mentor and...control methodologies and data anlaysis to ensure the quality and reliability of autoinjector and syringe products, and… more
- Repligen (Hopkinton, IA)
- OverviewWe are seeking a Document Control /QA Associate I to join our growing Quality Department team in Hopkinton, MA for 1st shift operations (M-F) from 8 am ... documentation requests. They will work closely with cross-functional teams and within document control and overall quality department to ensure the changes are… more
- Merck & Co. (Rahway, NJ)
- …set tactical and strategic direction on programs to ensure delivery of high- quality products, test methods, and robust manufacturing processes for both clinical and ... particularly in the design, manufacturing, verification, validation and associated quality and regulatory aspects of combination products.The incumbent must be… more
- Merck & Co. (Durham, NC)
- …manufacturer? If so, then this is the opportunity for you! The Lead Maintenance Technician is responsible for providing equipment troubleshooting and maintenance ... an empowered team culture including significant interaction with Production, Technical Operations, Quality and other support groups.This is a day shift position, 12… more
- BioAgilytix (Durham, NC)
- …operational data to lay the groundwork for future predictive models focused on quality control , lab maintenance, and operational forecasting.Assess core lab and ... a foundational data governance framework, with hands-on responsibility for data quality , access control , and compliance protocols.Define standards, build … more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …to Pharmacovigilance (PV) oversight. This role fulfills the PV Oversight function in PV quality control processes, as well as providing SME-level input from the ... Oversight Vendor Assessment team with 'Right First Time' mindset to effectively perform quality assessments and deliver quality control on identified areas… more
- Twist BioScience (South San Francisco, CA)
- …with data analytics tools and methodologies for process monitoring and quality control in biotech, including building custom reporting dashboards.About ... experienced and highly motivated Manufacturing Execution System (MES) Director to lead the strategic development, implementation, and optimization of our custom,… more
- Novo Nordisk Inc. (Durham, NC)
- …processes, machine learning for anomaly detection and predictive maintenance, advanced control strategies for quality improvements, inventory management using ... life-changing careers, and the opportunity to help improve the quality of life for millions of people around the...us make what matters. The Position Serve as a Lead & Subject Matter Expert (SME) to provide technical… more
- Merck & Co. (Rahway, NJ)
- …Development, Estimation and Planning, GMP Compliance, Management Process, Manufacturing Quality Control , Medical Supply Management, Medicinal Chemistry, ... its' Performance Qualification and Process Simulation execution, the selected candidate will lead and contribute to the launch and regulatory certification of the… more
- Tris Pharma (Monmouth Junction, NJ)
- …coordinates and advances required documentations, in liaison with Product Development (PD)/ Quality Assurance (QA)/ Quality Control (QC)/Regulatory Affairs, ... (CCRs), methods, specifications, protocols and reports. She/he acts as MV lead for assigned projects regularly reporting status/issues to management, conducts… more
- Merck & Co. (Rahway, NJ)
- …on autoinjectors, prefilled syringes, and other drug delivery systems. The director will lead a team of engineers and technical staff to support global and ... launch in alignment with the company's business goals, and quality and regulatory compliance.-Essential Duties and Responsibilities:Strategic Leadership and Project… more
- Aequor (Thousand Oaks, CA)
- …Drug Product Formulation and Vial/Syringe Filling operations Experience with various quality systems including change control , deviations, corrective and ... This "Specialist Manufacturing" role will serve as a New Product Introduction Lead within the New Product Introduction, Manufacturing Execution Systems, and Digital… more
- Merck & Co. (Durham, NC)
- …Mindset - Demonstrated ability to deliver compliant supply and achieve highest quality , lowest cost, and shortest lead -time. Strategic Thinking - Ability ... Vaccine Products. Our team works with a "Safety First, Quality Always" mindset.-As the primary point of contact for...and Activities include but are not limited to : Lead an Integrated Cross-Functional Team in Delivery of Reliable… more
- Formation Bio (New York, NY)
- …infrastructure at the intersection of data engineering and applied AI. You'll lead efforts to ingest and transform unstructured and structured research, biomedical ... and clinical data into high- quality , actionable assets that power discovery and decision-making across...thrives on technical depth, mentorship, and platform thinking. You'll lead the design of scalable systems that transform both… more
- Eisai, Inc (Exton, PA)
- …will collaborate effectively with other Development groups as well as with Facilities, Quality Assurance, Quality Control , Regulatory, and CMC Program ... Interact cross-functionally with Support Services, Facilities, Biologics Process Development, Quality Assurance, Quality Control , Validation, and… more
- Merck & Co. (Durham, NC)
- …the Master Data team with general Material Handling Steward tasksDrive safety, quality and process enhancements throughout the supply chain - Project Management ... Lead and sponsor all Supply Chain Logistics initiatives surrounding qualification support of off-site warehouse facilities for ambient and -70 storage capacity needs… more
- Merck & Co. (Rahway, NJ)
- …development and commercialization and understand the needs related to commercial quality control .Have working knowledge of developing various analytical ... within a regulated supply environment.Responsibilities include but are not limited to: Lead and oversee analytical investigations with a strong focus on quality… more
- Merck & Co. (Rahway, NJ)
- …Development, Biologics Process Research and Development, CMC and Regulatory in aspects of control strategy and filings, Quality and our partners in the ... accelerate process and product development and manufacturing and ensure safety and quality of our products. The successful candidate will be accountable for… more
- Merck & Co. (Rahway, NJ)
- …be expected to apply his/her knowledge of product development and design control principles to positively support and influence clinical and commercial combination ... ResponsibilitiesLead/contribute to device development, design controls for the assigned projects. Lead the implementation and/or ensure effective execution of the… more
- Merck & Co. (Rahway, NJ)
- …to customers both internal and external to GCS and serve s as the lead GCS spokesperson at clinical and development related meetings .- Working independently, the ... to: - - Interacts closely with key partner organizations ( as a lead GCS Planning program representative ) such as clinical development, regulatory, quality… more
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