- Insmed Incorporated (San Diego, CA)
- …packaging, distribution and releaseFocus on establishing, implementing, and maintaining quality operations systems that support manufacturing activitiesPerform ... write reports and follow up on audit responses and CAPA implementation.Establish Quality Agreements with GTx Technical Operations and CDMOs, associated vendors… more
- Merck & Co. (Rahway, NJ)
- …development to the next level. The key responsibilities of the Clinical Supply Quality Operations & Technology team include development and support for Clinical ... functions within the clinical supply chain. The Business Analyst role within Quality Operations & Technology is specifically focused on working with the CSQ… more
- Merck & Co. (Rahway, NJ)
- Job Description Job Description: The Rahway based Senior Specialist, Global Development Quality Operations - API, is responsible for independent review and ... relationships and effective communications with all stakeholders in all manufacturing operations , analytical testing, quality assurance, regulatory, etc. at all… more
- Tris Pharma (Monmouth Junction, NJ)
- …(CPIs), Product Quality Complaints (PQC) documentation, compliance efforts, quality operations , etc. Responsibilities:Assures compliance with all SOPs, cGMP, ... Leadership, etc.) on deviations and PQC investigations relating to production operations , quality operations oversight and quality control analysis… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …the lead who is responsible for ensuring that all aspects of our patient quality and safety operations meets standards. This position requires a highly motivated ... Qualifications Bachelor's degree or equivalent experience required 8+ years of operations , quality assurance, call center, compliance, project management, … more
- Merck & Co. (Durham, NC)
- …substance and drug product, including product inspection, warehouse, utilities, and quality control laboratories.The Specialist, Operations will be responsible ... experience in a sterile bulk, biologics or pharmaceutical environment, operations , technical services, supply chain, and/or quality operationsExperience… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …planning and individual protocols to facilitate successful implementation of programs. Clinical Operations :Ensure high quality delivery of all studies for which ... operational planning, start-up, conduct, reporting, and close out) including timeline, quality , and budget management. Drives and leads the successful execution of… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …of batch release related impact assessmentsSupport compliance activities for site Quality Operations in accordance with Legend standards, procedures and ... for nonconformance initiationSupport the Quality Leaders in meetings with quality counterparts that include Manufacturing Operations , Operations … more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …scientific knowledge.Key relationships: works in a collaborative team setting with quality counterparts that include Manufacturing Operations , Engineering and ... a QA Laboratory Compliance Manager as part of the Quality team based in Raritan, NJ. Role OverviewThe QA...is an exempt level position with responsibilities for providing quality oversight over the compliance program for the site… more
- Merck & Co. (Durham, NC)
- …participates in HAZOPS, waste walkthroughs, 5S, kaizen events, or any other operations , lean six-sigma, quality , safety or environmental training/initiatives as ... Job DescriptionOur Manufacturing Operations teams are the people that make our...work in the manufacturing plants with a "Safety First, Quality Always" mindset striving for continuous improvement. We work… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …scientific knowledgeKey Relationships: works in a collaborative team setting with quality counterparts that include Manufacturing Operations , Engineering and ... Document Control Specialist (1st Shift) as part of the Quality team based in Raritan, NJ. Role OverviewThe QA...tasks in a manner consistent with the safety policies, quality systems and cGMP requirementsReview and approve SOPs, and… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- … in a controlled cGMP cleanroom environment.Work with Process Development team, Quality and Operations organization to successfully transfer process to cGMP ... myeloma.Legend Biotech is seeking a Supervisor, QC Micro as part of the Quality Control team based in Raritan, NJ. Role OverviewThe QC Microbiology Supervisor, CAR-T… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …Plans, and Annual Product ReviewsWorks in a collaborative team setting with Quality , Manufacturing Operations , Facilities & Engineering Quality Control, ... Biotech is seeking CQV Specialist (Contractor) as part of the Technical Operations team based in Raritan, NJ. Role OverviewThis position will be responsible… more
- Merck & Co. (Durham, NC)
- …in safety & housekeeping walkthroughs, 5S, kaizen events, or any other operations , lean six-sigma, quality , safety or environmental training/initiatives as ... trained individuals with expertise working in aseptic production and manufacturing operations . The individual in this position will support the Vaccine manufacturing… more
- Merck & Co. (Durham, NC)
- …participates in HAZOPS, waste walkthroughs, 5S, kaizen events, or any other operations , lean six-sigma, quality , safety or environmental training/initiatives as ... but are not limited to; This is a night shift position. Support operations production through start-up and commissioning and qualification through licensure and ramp… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …procedures, standards and GMP regulations.Work with Process Development team, Quality and Operations organization to successfully transfer process/analytical ... Biotech is seeking QC Analyst as part of the Quality team based in Raritan, NJ. Role OverviewThe QC...of cell therapy products for clinical trials and commercial operations in a controlled GMP environment.Key Responsibilities Be responsible… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …concerns.Key Relationships:Ability to interact with all levels within the organization. Operations , Quality , HSE, Supply Chain, Warehouse, Training, QC, ... is seeking a Supervisor, Maintenance (3rd shift) as part of the Technical Operations team based in Raritan, NJ. Role OverviewThe CAR-T Supervisor, Maintenance is an… more
- Merck & Co. (Durham, NC)
- …manufacturing industry, specifically in pharmaceutical operations , technical operations , validation and/or process Quality Assurance.Required Experience and ... Job DescriptionSenior Specialist, Quality Systems and ComplianceOur company is expanding its...approve BOM changes and Master Batch Records.Review and approve Operations , Technology, or Automation protocols.Leads or actively participates in… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …is required.Key Relationships: Ability to interact with all levels within the organization. Operations , Quality , HSE, Warehouse, Training, QC, EM, Operations ... OverviewThis position will be responsible for maintenance support and mechanical system operations for cGMP Clinical and Commercial Cell Therapy Manufacturing on a… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …delivery and people Ability to interact with all levels within the organization: Operations , Quality , HSE, Supply Chain, Warehouse, Training, QC, EM, ... myeloma.Legend Biotech is seeking Metrology Supervisor as part of the Technical Operations team based in Raritan, NJ. Role OverviewThis position will be responsible… more
