- Legend Biotech USA, Inc. (Raritan, NJ)
- …promise of an immunotherapy in the treatment of multiple myeloma.Legend Biotech is seeking Quality Project Management Specialist as part of the Quality team ... is an exempt level position. The position's responsibilities include providing quality oversight over process improvement projects within a cell therapy… more
- Aequor (Devers, TX)
- Quality Sample Management Devens, MA - 100% Onsite Role 6 Months Contract - with High Possibilities of Extension Work Schedule Second Shift 2PM - 10PM. Monday ... in a cGMP compliant environment. Performs routine inventory and sample management of routine samples, critical reagents and non-routine samples. Main… more
- Merck & Co. (Durham, NC)
- …governance to the Durham Site in the following Quality Systems: Change Management , Quality Management System (QMS), and Documentation Management .- ... management and leadership for following Quality Systems: Change Management , Quality Management System (QMS), and Documentation Management .-Ensure… more
- Exela Pharma Sciences, LLC (Lenoir, NC)
- …SummaryThe Quality Director is the senior leader and decision maker for the Quality Department and Quality Management System. This position is ultimately ... all regulatory standards. This position is the decision maker for the Quality Management System deployed throughout the company. The Quality Director will… more
- Aequor (Thousand Oaks, CA)
- …positions available - admin hours 8-5 Mon - Friday. Ideal candidate: Experience with quality management systems and 5&plus YOE. Nice to have: Veeva knowledge. Ex ... the product complaint system at through triage of product complaints and management of Level I complaint processing and closure in adherence with Complaint… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …and proficient in creation of process maps preferredExperience working with Quality Management systems preferredExperience with requirements related to global ... Director, Development SOP Management Join a Legacy of Innovation 125 Years...Authorship and Review Maintain a close working relationship with Quality Assurance and participate in the Company Global SOP… more
- Aequor (West Greenwich, RI)
- …accurate, and documented according to written procedures and cGMP requirements. Alert management of quality , compliance, supply and safety risks. Complete ... office based, lab based, manufacturing floor? This is plant quality assurance role, therefore the EW will spend 50-60%...this vital role, will be responsible for PQA (Plant Quality Assurance) On the Floor in support of Manufacturing… more
- Aequor (West Greenwich, RI)
- …accurate, and documented according to written procedures and cGMP requirements. Alert management of quality , compliance, supply and safety risks. Complete ... Job Details: In this vital role, will be responsible for PQA (Plant Quality Assurance) On the Floor in support of Manufacturing activities. This position requires… more
- Aequor (South San Francisco, CA)
- …goal of driving data-driven decision-making throughout the study lifecycle. The Risk Based Quality Management (RBQM) Data Analyst sits in the Data Intelligence ... Leads and other RBQM workgroup members to develop and operationalize the integrated Quality Risk Management Plan (iQRMP) and associated risk mitigation and… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …ensuring the quality of PM activities including: communication, planning and management of schedule, budget, scope, issue risk management , and quality ... and Corporate Functions. They are responsible for ensuring consistent and effective management of approved Global and Regional IT projects and optimized PM resource… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …by the GQLs, EPQLs, and BPQLs, to internal and external stakeholders of R&D Quality .Support the oversight and management of CAPAs by tracking and following up ... immune disorders. SUMMARYProvide support to the Global and Regional Quality Leads, External Partner Quality Leads, and...quality reports and outputs (JOC, QRB, QQRs, EMR).CAPA Management Support the oversight and management of… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …supports CAPAs (Corrective and Preventive Actions) and CCs (Change Controls) within quality management systems. You will also write SOPs (Standard Operating ... Procedures) and work instructions that are part of the QMS ( Quality Management System).You combine the knowledge of the employees in the maintenance process, the… more
- Twist BioScience (South San Francisco, CA)
- …to achieve aggressive goals. Experience with ISO 13485 design control and Quality Management Systems.Superior interpersonal skills and ability to develop ... decisions and exercises sound judgment.Strong work ethic, commitment to the highest quality of workProficient with project management tools and applications… more
- Exela Pharma Sciences, LLC (Lenoir, NC)
- …calibration procedures and calibration certificates. Perform testing to support the quality management system and report, troubleshoot and make recommendations ... and work instructions to support the manufacturing process and the quality management system. Reviews and processes external calibration certificates.Complete… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …requirements and breakdowns.cGMP manufacturingMaintenance and facilities managementComputerized maintenance management systems (CMMS) Quality Management ... standards.Performs work review, approval and close out of work orders, including management of third-party vendor work, in accordance with established guidelines and… more
- Exela Pharma Sciences, LLC (Lenoir, NC)
- …into microbiological and manufacturing process nonconformances.Assist Sterility Assurance and Quality management during routine audits by regulatory agencies, ... This individual should be able to work with direction from Sterility Assurance Management to uphold the policies and procedures related to completion of media… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …Program Management team to ensure vendor compliance with all quality /safety requirements; educates on process requirements Partners with compliance and Program ... Bachelor's degree or equivalent experience required 8+ years of operations, quality assurance, call center, compliance, project management , operations and/or… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …discipline and its application to drug development required to deliver time, cost, quality , and risk management to teams.Demonstrated results in creating and ... OverviewThis position will be responsible for providing operational excellence project management support to the cGMP Clinical and Commercial Cell Therapy… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …handling day-to-day activities inclusive of project execution and management , vendor management , data life cycle management , Quality events, remediation ... policies and procedures.Handling day-to-day activities inclusive of project execution and management , vendor management , data management , life cycle… more
- Exela Pharma Sciences, LLC (Lenoir, NC)
- Position SummaryThe Technical Data Reviewer reports to the Data Review Supervisor or quality management (ie, Manager or Director). The reviewer will be ... requirements.Job ResponsibilitiesReview logbooks for daily, monthly, quarterly, and final Quality Review.Review and approve Particle Matter, Helium Leak, Physical… more
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