- Aequor (Thousand Oaks, CA)
- …include evaluation of compliance issues, providing recommendations, and assuring progress of quality records to completion. The Sr. Associate will also represent ... perform GMP operations including following detailed SOPS, maintaining training, and good documentation practices. Also, ability to make Quality based decisions… more
- Merck & Co. (Rahway, NJ)
- Job DescriptionPosition Description: Associate Clinical Research Associate - Northeast Region (Remote) With support of Senior Clinical Research Associate ... in a timely manner.Collects, reviews, and monitors required regulatory documentation for study start-up, study maintenance and study close-out.Communicates with… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …Directive, and International Conference on Harmonization (ICH) guidelines. The Associate Director is accountable for operational planning and execution at ... planning start-up, conduct, reporting and close out) including timeline, quality and budget. A key focus will be the... of data is suitable for regulatory submission. The Associate Director will have routine interaction with key internal… more
- Merck & Co. (Rahway, NJ)
- Job DescriptionWith support of Sr CRA (Clinical Research Associate ) and/or CRA Manager, acts as primary site contact and site manager-throughout all phases of a ... in a timely manner.-Collects, reviews, and monitors required regulatory documentation for study start-up, study-maintenance and study close-out.Communicates with… more
- Merck & Co. (Rahway, NJ)
- …of our Research & Development Division is seeking applicants for an Associate Principal Scientist position available at its Kenilworth, New Jersey research ... facility.- The Associate Principal Scientist is a laboratory-based scientific role tasked...in Analytical Methodologies and sound scientific understanding of Critical Quality Attributes/QbD/DOE principles as well as data analysis and… more
- Catalent (San Diego, CA)
- Quality Assurance Associate II - Manufacturing Catalent Pharma Solutions in San Diego is currently hiring a Manufacturing Quality Assurance (MQA) ... of activities pertaining to supporting, maintaining, and assuring compliance with quality systems requirements and applicable regulatory requirements; to advance the… more
- Merck & Co. (Durham, NC)
- Job Description Associate Technician - - 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...necessary for production . - Provides and/or authors all documentation and clerical functions necessary to allow proper accountability… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …of an immunotherapy in the treatment of multiple myeloma. Legend Biotech is seeking Quality Systems Lead role as part of the Quality Operations team based ... in Raritan, New Jersey. Role Overview The Quality Systems Lead role is an exempt level position...approval of standard operating procedures and any other required documentation . Collaborate with functional departments to resolve issues. Perform… more
- Insmed Incorporated (Bridgewater, NJ)
- …Biopharma™, Best Workplaces in New York™, and Best Workplaces for Millennials™ lists.OverviewThe Quality Control Associate will serve as a strategic and tactical ... composing investigations as it pertains to testing and resultsAssists with documentation formatting. Formatting may include creating templates, fonts and style,… more
- Merck & Co. (Rahway, NJ)
- …reliance on automation within Biologics Process Research & Development (BPR&D).The Associate Director role-will provide process automation leadership within the BDC ... -Execute and develop appropriate system validation, change control, and testing documentation in partnership with project CQV and IT teams.Establish GxP systems… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …you ready to make a difference? The Position Responsible for the receipt, documentation , triage and quality assessment of inbound safety information, including ... find better and more innovative ways to improve their quality of life. We're changing lives for a living....associated technical complaints and provide ongoing feedback regarding case quality to other case handlers to support their continued… 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 ... processes and implementing changes to enhance efficiency, productivity, and quality . Encouraging a culture of continuous improvement, promoting innovation, and… more
- Aequor (Thousand Oaks, CA)
- …in protein biochemistry and cell biology for the position of Process Development Associate , to join our Critical Reagent Group. The Critical Reagent Group serves our ... required for characterization, in-process and release testing of biological products. The PD Associate will work with a team of talented scientists to mainly lead… more
- Novo Nordisk Inc. (Boulder, CO)
- …to support analytical and process development, the CMC team works alongside Quality , Regulatory, Technical Operations and RNAi Early Development professionals at our ... make a difference? The Position Novo Nordisk is seeking a highly motivated associate scientist to join the Analytical Development team in Boulder, CO. The candidate… more
- Aequor (Thousand Oaks, CA)
- …and spectroscopic techniques. * Demonstrate independence and ability to produce quality results under minimal direction * Generate complete, accurate, and concise ... documentation using electronic systems and laboratory notebook * High...not limited to, the maintenance of training records, laboratory documentation , written procedures, building monitoring systems and laboratory log… more
- Aequor (Newbury Park, CA)
- …in what we do. Detail oriented, to be able to monitor data quality . Comfortable learning new systems/processes. Someone who is able to follow instructions/guides, ... understands the importance of details, since we work so much with monitoring Data Quality and someone who is able to communicate clearly with internal and external… more
- Lundbeck (Bothell, WA)
- …support on a variety of analytical techniques, data analysis, and documentation . Additionally, there will be opportunities to participate in assay optimization ... role will interact with Lundbeck Seattle Upstream, Downstream, Formulation, and Quality Control groups so strong interpersonal skills will be beneficial.ESSENTIAL… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …opportunity employer including veterans and people with disabilities. Summary The Associate Director, External Data Management, is accountable for the end-to-end ... on behalf of Daiichi Sankyo. This position also ensures quality delivery of all 3rd party data from diverse...programs. Is accountable for inspection readiness of external data documentation filed/archived in Trial Master File (TMF) according to… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …protocol amendments, site staff and location changes and IRB/REB/regulatory approvals to assure quality of the documentation files and compliance with NN SOPs, ... find better and more innovative ways to improve their quality of life. We're changing lives for a living....difference? The Position Drives the understanding & delivery of quality clinical research (patient safety, rights & wellbeing; data… more
- Eisai, Inc (Nutley, NJ)
- …to hear from you.JOB SUMMARY:As a member of the Data Analytics group, the Associate Director, Commercial Analytics is part of a high performing team that provides ... for the department, and monitors compliance with these standards.Oversee data quality management process for assigned brand/s with external and internal data… more
