- Legend Biotech USA, Inc. (Raritan, NJ)
- …the promise of an immunotherapy in the treatment of multiple myeloma.Legend Biotech is seeking a Quality Systems Lead as part of the Quality team based ... in Raritan, NJ. Role OverviewThe Quality Systems Lead role is an exempt level... site .Oversee metrics, trending, and reporting of relevant quality systems records.Support CAPA site … more
- Merck & Co. (Rahway, NJ)
- …a single-use environment, and bioprocessing equipmentStrong working knowledge of cGMP, Quality Systems (problem, deviations, change management, etc.), Safety for ... Job DescriptionApplications are sought for a Process Engineering Lead position in o ur Reseach & Development Division Biologics Process Research & Development… more
- Merck & Co. (Millsboro, DE)
- … lead a high-impact Integrated Process Team that directly influences site performance, product quality and cost-of-goods for life-changing animal vaccines. ... Your leadership will shape manufacturing systems and release processes that enable reliable, efficient vaccine...focused on continuous improvement.Be accountable for IPT performance against site and division goals, including quality , safety,… more
- Merck & Co. (Durham, NC)
- …our products. We work in the manufacturing facility with a "Safety First, Quality Always" mindset, always striving for continuous improvement. We work in the local ... to our global manufacturing network to ensure the highest quality of raw materials, intermediates and finished products.The Maurice...employees over the last several years; currently the Durham site employs 1,000+ people.The Durham site is… more
- Merck & Co. (Durham, NC)
- …make our products. We work in the manufacturing plants with a "Safety First, Quality Always" mindset striving for continuous improvement. We work in the local plant ... connected to our global manufacturing network to ensure the highest quality of raw materials, intermediates and finished products.- Position Description - This is a… more
- Merck & Co. (Upper Gwynedd, PA)
- …on existing Data & Analytics (D&A) products and link usage to business outcomes. Lead data transformations, data quality , data governance, advanced analytics, and ... SDLCManaging diverse projects and processes within GCTO/MAP Teams.Champion data quality , integrity, and reliability by designing and promoting best practices.Bridge… more
- Merck & Co. (Rahway, NJ)
- …research including at least 2 years with developing and managing clinical quality systems and management of regulatory inspections.Profound knowledge and ... Job DescriptionIn partnership with the Clinical Quality Operations Lead (CQOL and Head...clinical development programs, clinical trial processes as well as quality management systems and quality … more
- Merck & Co. (Rahway, NJ)
- …Director Packaging Technical Operations the Director Packaging Distribution, Components and Systems Center of Excellence (COE) is responsible and accountable for ... molecule bulk and primary packaging components and packaging master data and systems .The Packaging Technical Operations organization aims to be an industry leader in… more
- Merck & Co. (Durham, NC)
- …production, and quality groups to ensure facility operations and systems comply with required standards. Lead / participate in discussions with contractors, ... daily priorities and schedules project/work meeting the criteria established by site objectives.Support & lead Utility equipment related projects, scope… more
- Merck & Co. (Rahway, NJ)
- …products, with a focus on autoinjectors, prefilled syringes, and other drug delivery systems . The director will lead a team of engineers and technical ... proficiency in ISO 13485, ISO 14971-2019, and other relevant quality management systems .Qualifications:Bachelor's degree in Mechanical Engineering, Biomedical… more
- Merck & Co. (Rahway, NJ)
- …Engineering, Inventory Control System, Inventory Management, Mechanical Testing, Medical Device Quality Systems , Negotiation, Project Management, Quality ... Responsibilities: Strategic LeadershipDevelop and implement digital strategies to ensure high- quality , compliant, and actionable data flows across DD&T and supply… more
- Merck & Co. (Rahway, NJ)
- …proficiency in ISO 13485, ISO 14971-2019, and other relevant quality management systems .Qualifications:Bachelor's degree in mechanical engineering, Biomedical ... testing, and process validation, with a strong understanding of quality management systems and regulatory compliance.Demonstrated technical leadership… more
- Merck & Co. (Durham, NC)
- …performance management). Additionally, they must become proficient in the use of manufacturing systems and knowledgeable of site procedures in order to resolve ... process/equipment issues, minimize downtime, and ensure product quality .--This role will support manufacturing activities at the Durham Site . Successful… more
- Merck & Co. (Rahway, NJ)
- …deliver: - Increased productivity and speed to clinic/market - Accelerated timelines for site , filing, and launch readiness- - Improved access to product and process ... to create a frictionless flow of data from source systems to regulatory documentation .-- - Under the guidance...Management & Communication : The analyst will organize and lead information gathering sessions with the internal CMC community,… more
- Merck & Co. (North Wales, PA)
- …through project close-out.Thorough knowledge and proven expertise in GMP application and quality systems , particularly in process and equipment qualification & ... source change and/or device component source changes.The incumbent will lead or support complex global and site -centric...will lead or support complex global and site -centric capital and equipment projects.- These projects would include… more
- Merck & Co. (Rahway, NJ)
- …commercial manufacturing biologics. For commercial programs, activities include site -to- site process transfers, manufacturing investigations and trend ... a cross-functional team.-Ensures project results meet requirements regarding technical quality , reliability, schedule, and cost.Monitors performance and recommends schedule… more
- Merck & Co. (Rahway, NJ)
- …TA aligned deliverables that align with V&I Goals and serves as the Lead for the US Medical Affairs Team (MAT) meetings.Establish and maintain strategic partnerships ... with Health Systems (HS) by leading RMSD medical account planning initiatives...engages with Country Medical Affairs and TA leadership to lead strategic alignment, optimal resource allocation, and effective representation… more
- Merck & Co. (Rahway, NJ)
- …of scientists and engineers who are responsible for delivering robust packaging systems for cell banks, drug substance, drug product, and finished goods.- ... the design, characterization, qualification, and tech transfer of robust packaging systems to commercial sites, as well as packaging process co-development with… more
- Merck & Co. (Rahway, NJ)
- …of 6 years of experience in pharmaceutical development, device development, device systems operations, quality management, or a related area. Strong knowledge ... Job DescriptionJob Description The Senior Scientist, Device Design Control Lead , is a crucial member of our team, responsible for spearheading design control efforts… more
- Merck & Co. (Irving, TX)
- …, Inventory Management, Lean Manufacturing, Machinery Operation, Manufacturing Quality Control, Process Improvements, Production Planning, Production Scheduling, Six ... coordinates production associates to meet production schedules in compliance with the Quality System, EHS and company policies while ensuring that equipment and… more
