- Merck & Co. (Rahway, NJ)
- …a specific therapy area will collectively and periodically (eg quarterly) perform a TA-level review of quality plans and risk mitigation approaches in order to ... but not be limited to:Facilitating and monitoring CTT oversight of vendorsDevelopment, review and revision of quality agreements with business partners (ie… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …business functions in a timely manner through appropriate forums, such as Quarterly Quality Reports (QQRs) and Quality Review Boards (QRBs).Collaborate with ... quality reviews of product profiles, ensuring thorough management review of all quality and compliance topics, including Key Quality Indicators (KQIs).… more
- Aequor (Thousand Oaks, CA)
- …(POR) - Support reconciliation and return of investigational products Temperature Data & Quality : - Review shipment temperature data and assess excursions with ... report onsite if systems go down and manual processes required. Experience with Quality Management Tracking Systems (QMTS) is preferred but not required - full… more
- Merck & Co. (Millsboro, DE)
- Job DescriptionThe Quality Assurance Director will provide compliance leadership and direction to our Company and contract manufacturing operation (CMO) sites that ... vaccine drug substances and finished products. As Director, you will support Quality audits and health authority inspections and ensure any resulting corrective and… more
- Merck & Co. (Durham, NC)
- …to interface with Operations, Global Vaccine Technology (GVTE), Automation, and Quality approvers.-Perform a thorough review of design & engineering ... site includes an Energy Center, Vaccines DP and DS Manufacturing Facilities, Quality Labs, various other manufacturing buildings and Maintenance and Material Storage… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …of obligations deriving from these contracts. Organize and conduct periodic review of contract quality and adherence PV Regulatory Intelligence:Contribute ... and dissemination across CSPV stakeholders for impact assessment. Participates in the review and management of monthly, quarterly, and ad hoc PVRI reports received… more
- Aequor (Irvine, CA)
- Job Description: Major Accountabilities: Review and investigate assigned technical and clinical customer complaints. Perform hands-on technical investigations and ... and completes associated technical documentation Assist complaint intake group through review and verification of initial complaint coding. Monitor post-market and… more
- Repligen (Waltham, MA)
- OverviewWe are seeking an experienced Director of Quality candidate to lead Repligen's Waltham, MA facility which has proven experience in the biotechnology ... industry. This leader will be responsible for managing the site quality assurance team which includes all day-to-day activities for product manufacture, test and… more
- Eisai, Inc (Nutley, NJ)
- …If this is your profile, we want to hear from you. Director, Clinical Quality Assurance The Director, Clinical Quality Assurance position is responsible for ... design, delivery and execution of the North America (NA) Clinical Quality Assurance (CQA) strategy including audit and inspection management and oversight of the … more
- Aequor (West Greenwich, RI)
- …and Environmental/Water monitoring. 2. Perform testing and possible data review for compendia, non-compendia methods, and routine laboratory procedures. 3. ... Generate complete, accurate, and concise laboratory documentation using electronic systems and laboratory notebooks. 4. Operate and maintain specialized laboratory equipment and instrumentation. 5. Participate in laboratory investigations and audits as… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …multiple and complex cross-functional projects with many stakeholders.Support other quality systems activities, as needed.Support drafting, review and ... 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… more
- Merck & Co. (Millsboro, DE)
- …lead IPT support for audits, inspections, validations and corrective actions.Author, review and approve SOPs, Quality Notifications and technical documentation; ... Integrated Process Team that directly influences site performance, product quality and cost-of-goods for life-changing animal vaccines. Your leadership will… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …CAR-T drug product for human use. This position is responsible for quality and maintaining the highest standards in compliance within company policies, procedures, ... the team responsible for QA oversight of final CAR-T product batch record review and release practices.Lead the establishment and improvement of QA practices to… more
- Aequor (Louisville, KY)
- … quality results, and taking appropriate action when corrections are necessary Review histology slides for quality and consistency Perform special stains as ... pathologists, and other lab personnel to ensure the highest standards of quality and accuracy in our diagnostic services. Position Responsibilities: Under minimal… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …myeloma.Legend Biotech is seeking a QA Shop Floor Specialist as part of the Quality Operations team based in Raritan, New Jersey. Role OverviewThe QA Shop Floor ... Specialist is an exempt level position responsible for the floor quality oversight of the production of autologous CAR-T products for clinical trials and commercial… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …organizations, and study investigators- Manage vendor budget and activities- Oversee the quality and timeline of vendor work- Collaborate with study clinical or ... and biostats to ensure availability of necessary data- Coordinate author review /approval internal review approval- Abstract/manuscript submission with vendor… more
- Merck & Co. (Rahway, NJ)
- Job Description Global Quality Large Molecule Analytical Sciences (GQ- LMAS) - Analytical Transfer Team Our Manufacturing Operations teams are the people that 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… 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
- Legend Biotech USA, Inc. (Raritan, NJ)
- …multiple myeloma.Legend Biotech is seeking QA Investigations Lead I as part of the Quality team based in Raritan, NJ. Role OverviewThe QA Investigation Lead is an ... Investigation Excellence Team. The QA Investigations Lead is responsible for providing quality oversight and guidance during the investigation of events that occur… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …myeloma.Legend Biotech is seeking QA Validation Specialist I as part of the Quality team based in Raritan, NJ. Role OverviewThe QA Validation Specialist role is ... an exempt level position with responsibilities for providing quality oversight over the validation and qualification activities for equipment, systems, computer… more
