- Aequor (South San Francisco, CA)
- … visualization and conduct predictive analysis to increase the efficiency of clinical data review and clinical operations with the ultimate goal of driving ... to optimize the support of clinical systems to provide high- quality clinical trial data insights and to...Management Plan (iQRMP), and to manage the identification of critical-to- quality (CtQ) factors, development of risk control … more
- Merck & Co. (Durham, NC)
- …with Quality Management Systems and Change Management. Experience performing review and completing change control impact assessments. Proven expertise of ... review of topics of responsibility at the Site Quality Council Meeting per the QC standard.Direct support of...the FDA regulations and cGMPs with experience in document control and quality management in a highly… more
- Merck & Co. (Millsboro, DE)
- …and state regulatory requirements for animal welfare, management of controlled substances, quality control testing according to GMP standards, and emissions ... of the animal care staff, serving as a designated reviewer and voting member of the Institutional Animal Care...facilitating communication between the Animal Services team and the Quality organization. This position will work in close coordination… more
- Novo Nordisk Inc. (West Lebanon, IN)
- …certify compliance with specifications and procedures Works closely with Manufacturing and Quality Control to resolve open issues resulting from record reviews, ... products. This position has QA signature authority on the review of individual batch records, supporting test records and...develops approach to solutions Ability to work on complex Quality projects where analysis of data requires… more
- Aequor (Devers, TX)
- …coverage as needed by Manufacturing Schedule. Responsibilities Performs routine processing and data review of raw materials, in-process, batch release, and/or ... with members of his/her team as well as other sub-teams within Quality Control Organization, in order to exchange information regarding sample management as it… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- … quality systems team, ad hoc, for activities such as annual product review , site risk register, or internal quality agreements.Develops and delivers training ... promise of an immunotherapy in the treatment of multiple myeloma.Legend Biotech is seeking Quality Compliance Manager as part of the Quality team based in… more
- Aequor (Thousand Oaks, CA)
- …are using. We are looking for a candidate with skills to support the quality control / review of nonclinical scientific reports. Title: Associate Research ... This will be an office based role, utilized for quality control of the instruments the Scientists...will provide oversight of nonclinical report QC, contribute to data integrity review of electronic lab notebooks… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …programs and other materials, including coordination with external suppliers and agencies. Ensure quality control of marketing material. Ensure quality ... Identify opportunities for improvement within the customer campaigns and engagement. Review and interpret campaign/tactic data to inform adjustments on… more
- Twist BioScience (South San Francisco, CA)
- …create screening assays for DNA/RNA modifying enzymes.Develop quantitative biochemical and quality control assays to characterize DNA/RNA modifying enzymes and ... novel research projects by designing, performing experiments and analyzing subsequent data .Coalesce abstract concepts into tangible goals and outcomes. Design and… more
- Novo Nordisk Inc. (West Lebanon, IN)
- …facility certification for new Manufacturing (process equipment & facility-support equipment) and Quality Control facilities as needed as well as the continued ... verification protocol execution (FAT, SAT, DQ, Commissioning, IQ, OQ, & PQ), data analysis and final report preparation Participate in the development and… more
- Novo Nordisk Inc. (Sacramento, CA)
- …activity records/reports, including timely and accurate transmission of call data Participate in relevant meetings, conventions, training programs, and displays ... audience needs, share learning objectives and local challenges, provide feedback on quality of presentation) to provide quality balanced and relevant… more
- Novo Nordisk Inc. (West Lebanon, IN)
- …and Manufacturing for the coordination of process/equipment improvements and data trending/analysis Review /approval of completed process documentation Ability ... manufacturing operations. Focus areas may include Training, Documentation, Deviations, Change Control and Projects. Drives the coordination and execution of process… more
- Novo Nordisk Inc. (Winter Park, FL)
- …activity records/reports, including timely and accurate transmission of call data Participate in relevant meetings, conventions, training programs and displays ... that maximize the opportunity to call on targeted customers Exercise prudent control over samples and other company property in accordance with company policies… more
- Exela Pharma Sciences, LLC (Lenoir, NC)
- …well as providing electrical engineering. The Sr. Controls Engineer will utilize data management skills, PLC (Programmable Logic Control ) skills, electrical ... Engineer will be responsible for installing, modifying, and servicing process control systems throughout the facility as well as providing electrical engineering… more
- Exela Pharma Sciences, LLC (Lenoir, NC)
- …the manufacturing processes as well as providing electrical engineering. Will utilize data management skills, PLC (Programmable Logic Control ) skills, electrical ... Summary:Controls Engineer is responsible for installing, modifying, and servicing process control systems throughout the facility as well as providing engineering… more
- Merck & Co. (Rahway, NJ)
- …submissions/variations, 510(K)s, CE markings. - Lead the development, communication, and review of Regulatory Strategies and execute on various deliverables for ... excellence, accuracy and completeness of submissionsPartner with Device Development, Device Quality , and other Drug stakeholders to communicate and align on new… more
- Merck & Co. (Rahway, NJ)
- …C linical T rial O perations (GCTO) Regional colleagues and Global Development Quality (GDQ) to address clinical supply related topics . - Responsible and ... analy ze s , and/or develops mitigation strategies for review with clinical partners and senior leaders.- - Responsible...business risks, & influence portfolio decisions with facts and data - Demonstrates ability to balance strategy with ability… more
- Merck & Co. (Rahway, NJ)
- …. Interacts with key partner organizations such as clinical development, regulatory, quality and other supply chain areas to address clinical supply related topics ... chain deliverables and prepares , analyses , and/or develops mitigation strategies for review with clinical partners and senior leaders. Works directly in the SAP… more
- Exela Pharma Sciences, LLC (Lenoir, NC)
- …Operations, Regulatory, Quality Assurance, Finance, R&D, Project Management and Quality Control departments to complete the technology transfer for ... those standards for all staff members, to include preparing and conducting performance evaluations. Review and ensure the reliability of technical data related to… more
- Merck & Co. (Baton Rouge, LA)
- …coordination leadership and implementation of troubleshooting activities and change control .Initiate and lead collaboration within the Operations, Quality ... issues, identifying trends, process monitoring, system administration, documentation updates, data querying, operator training, day to day operations support. T… more
