- Aequor (Thousand Oaks, CA)
- …for sampling and inspection of raw materials and components and for performing Quality review of documentation for assigned functions (eg equipment and ... maintenance records). Duties will include the operation and maintenance of instruments and equipment associated with sampling, eg, Toledo balance, drum lift, pallet jack, etc. Maneuvering of large drums required. Employees will also be responsible for the… more
- Eisai, Inc (Raleigh, NC)
- …to foster effective collaboration across teams.ResponsibilitiesExecute core processes within Quality area: Review manufacturing batch records for completeness, ... hear from you. The QA Specialist plays a critical role in ensuring the quality and compliance of commercial and clinical products manufactured at the Eisai Raleigh… more
- Repligen (Hopkinton, IA)
- …a timely manner while also serving as a resource for the review of quality documentation received from interdepartmental sources.ResponsibilitiesWorks with ... supports On-Boarding Training.Assists with employee Overdue TrainingTasks associated with the review of production and quality -specific documentation as assigned… more
- Twist BioScience (South San Francisco, CA)
- …quality reports by collecting, analyzing, and summarizing information and trendsWrite/ review product quality documentationFollow regulatory and ISO 13485 ... He/she will work closely with the operations team to monitor the quality of Twist DNA products utilizing quantitative measurements, fragment analysis, NGS… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …evolve, so does our challenge to find better and more innovative ways to improve their quality of life. We're changing lives for a living. Are you ready to make a ... difference? The Position Developing quality and strategic objectives and strong business understanding of...chair of PV Deviation Board to facilitate the pre-approval review by board members of all NNI Patient Safety… 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
- 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
- Aequor (Houston, TX)
- …deviations with the aim at identification of root cause, determining Product Quality Impact (PQI) and implementation of corrective actions to prevent recurrence. ... investigation, assessment of event for impact to Safety Identity Strength Quality Purity (SISQP), perform trending analysis, identification of Corrective and… 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
- Aequor (Thousand Oaks, CA)
- …experience is more important. Candidates should be familiar with manufacturing or quality operations and understand the pace and expectations of a high-volume, ... without industry experience will not be considered. This position supports 's Quality Assurance program under the Plant QA organization providing daily oversight of… 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
- 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
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …Reviews emerging clinical data regularly; Leads dose-escalation meetings; Performs quality assessment with Delivery Lead eg review Tables/Listings/Graphs ... Biostatistics Data Management & Data Ops for EDC, edit checks, data quality listings, SAP, Data Management plan; Reviews patient population and protocol compliance… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …myeloma.Legend Biotech is seeking QA Validation Specialist III 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
- Aequor (Houston, TX)
- …on-site 5x/week Responsible for tracking, management, and completion of Supply Chain Quality Records (such as deviations, material recalls, and CAPA) in partnership ... improvement initiatives based on identified recurring root cause. Serves as the Quality Record (PR) Subject Matter Expert (SME), Level I, for the Warehouse… more
- Aequor (East Syracuse, NY)
- …and coordinating timely transfer of test methods with and to Quality Control laboratories is desired. Specific Knowledge, Skills, Abilities, etc.Strong written, ... and/or commercial GMP manufacturing.Duties / ResponsibilitiesDevelop, author, and peer review standard operating procedures, analytical methods, protocols, reports, and… more
- Merck & Co. (Durham, NC)
- …needs to identify solutions.Works as a liaison between Maintenance, Deviation Management, Quality and other Site Business Partners.Initiate, Review or Approve ... 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
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …and immune disorders. Summary: The Senior Director, Head of RBQM (Risk Based Quality Monitoring) sets the vision and strategy for the RBQM function within R&D. ... Reviews and provides guidance to RBQM projects. Accountable for the quality and timeline for all RBQM deliverables. Promotes, oversees and is accountable for… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …role will work with Global Regulatory Affairs and cross-functional teams (eg, Quality , CSPV, Clinical Operations, Clinical Development, RA CMC) to keep processes, ... processes globally. This role will be responsible for coordinating the authoring, review and approval of new or updated procedural documentation. In addition, this… more
- Merck & Co. (Rahway, NJ)
- …and Original Equipment Manufacturers (OEM) and vendors.Provide engineering and quality engineering (QE) support, ensuring facility, utilities and equipment are ... maintained and are suitable for both GMP and developmental use.- Author, review and approve GMP procedures and documentation, with an emphasis on Qualification and… more
