- Bristol Myers Squibb (Devens, MA)
- …support across all capabilities with a primary focus on automation ( control systems), information technology, site infrastructure and computer system validation used ... with agility and urgency. + Responsible to strategically align site digital QC Lab operations with business applications teams across all commercial sites. +… more
- US Tech Solutions (Worcester, MA)
- …analysis utilizing hybrid manual and automated systems to generate high quality bioanalytical data. Reporting results to project teams which enable Pharmacokinetic ... report writing and day-to-day lab operations. * Sample management and sample data QC in LIMS. * Write, and update experimental protocols and procedures. * Initiate,… more
- Regeneron Pharmaceuticals (Cambridge, MA)
- …a typical day might include the following:** + Supporting all manufacturing and QC equipment within RCM's 30,000 SF Phase 1 clinical manufacturing facility + ... to manufacturing deviations and anomalies associated with automation systems and control system software + Support engineering and validation projects as well… more
- Takeda Pharmaceuticals (Boston, MA)
- …Excellence (DLE), Global Regulatory Affairs (GRA), Global Development Organization (GDO), Clinical Quality (CQA), and the PV & Medical Quality (PVMQ) functions. ... Social Digital Media, and Market Research/Patient Support Programs (MR/PSP) processes. Quality metrics for Individual Case Safety Reports (ICSR), Agregate Safety… more
- Fresenius Medical Center (Waltham, MA)
- …of issues in creative ways. + Responsible for the preparation, compilation, quality check and delivery of regulatory submissions in both paper and/or electronic ... system, regulatory information system, and electronic submissions. + Compiles, publishes, QC , and validates documents for FDA submission. + Troubleshoots document… more
- Takeda Pharmaceuticals (Boston, MA)
- …+ Strategic knowledge of FDA and ICH regulations and industry standards and quality control principles. + Solid experience applying System Development Life Cycle ... Clinical Data Operations & Standards. At Takeda, we are transforming the pharmaceutical industry through our R&D-driven market leadership and being a values-led… more
- Stantec (MA)
- …deliverables. + Meet deadlines and manage multiple priorities. + Provide quality assurance/ quality control of project deliverables. **Qualifications** ... EHS Compliance Specialist - ( 250000PV ) **Description** Grounded in safety, quality , and ethics, our experts lead their fields and guide our work with rigor, a… more
- Cytel (Boston, MA)
- …and deliverables are aligned with the relevant regulatory requirements. Responsible for quality control and audit readiness of all assigned statistical ... of experience in biostatistics or statistical programming activities in the Pharmaceutical or Biotechnology industry in clinical development, including: 2 years of… more
- Takeda Pharmaceuticals (Boston, MA)
- …+ Strategic knowledge of FDA and ICH regulations and industry standards and quality control principles. + Solid experience applying System Development Life Cycle ... Clinical Data Operations & Standards. At Takeda, we are transforming the pharmaceutical industry through our R&D-driven market leadership and being a values-led… more
- Astellas Pharma (Cambridge, MA)
- …and maintenance of medical science specific global standards, processes, SOPs, training and quality control , to the highest level of compliance with ICH, GCP ... you belong at Astellas! Astellas Pharma Inc. is a pharmaceutical company conducting business in more than 70 countries...of the Oncology Solid Tumor Development team. Accountable for quality in all work products of the team, ensuring… more