- LGC Group (Petaluma, CA)
- …our Quality Management System processes. Additionally, you will analyze process data , prepare trend analyses to drive continuous improvement initiatives, and ... and inspection readiness within organization. + Investigations: Performance and review for investigations associated with Complaints, Deviations, CAPA, OOS, Out… more
- Gilead Sciences, Inc. (Foster City, CA)
- …communication of strategy, key project timelines and CMC milestones. + Monitor and review cross-functional process and product data to identify trends to ensure ... to be a Product Quality Lead (PQL), Quality Assurance, in the Pharmaceutical Development and Manufacturing (PDM) organization. The PQL is a strategic matrixed… more
- Takeda Pharmaceuticals (Boston, MA)
- …Sciences in our Cambridge office. At Takeda, we are transforming the pharmaceutical industry through our R&D-driven market leadership and being a values-led company. ... to our inspiring, bold mission. **OBJECTIVES** **:** Responsible for ensuring ongoing review and agreement of the Therapy Area Strategy and associated documents… more
- Astrix Technology (New Brunswick, NJ)
- …creation, review , and closure of Change Control records. + Conduct quality testing, review QC data , and prepare Certificates of Analysis. + Maintain and ... + Develop and manage weekly schedules for QC analysts. + Author, review , and revise technical documents (protocols, specifications, reports, SOPs, test methods,… more
- Glenmark Pharmaceuticals Inc., USA (Monroe, NC)
- …is well-positioned to successfully emerge as a leading integrated research-based pharmaceutical company. POSITION SUMMARY: This position is responsible for overall ... Quality Management Systems (Investigation, Change Control, CAPA) and Annual Product Review (APR). JOB RESPONSIBILITIES: Financial: + Participate in preparation of… more
- IQVIA (Durham, NC)
- …a protocol, statistical analysis plans, table shells, programming and table specifications, data review , tables, listings, figures, and statistical sections for ... management deliverables (ie, database design, CRF design, validation checks, and critical data ). - Provide expert review of ADaM reviewers guide (ADRG) and… more
- Sanofi Group (Cambridge, MA)
- …benefit from the reach and resources of one of the world's largest pharmaceutical companies with a shared commitment to improving the lives of patients. Sanofi's ... forms of economic modeling, database analysis, observational research, systematic literature review , evidence synthesis, value dossier development and other types of… more
- Beth Israel Lahey Health (Boston, MA)
- …submits protocols, amendments, notices, suspensions and terminations to the IRB for review and approval. (essential) + Interacts with patients prior to entering the ... accompany (if applicable) and the IRB. May interact with sponsors and/or pharmaceutical company representatives. May prepare reports for pharmaceutical company… more
- Cambrex High Point (Longmont, CO)
- …Investigations, Corrective and Preventive Actions (CAPA), Change Control, Complaints, Quality review of analytical and microbiological data and batch production ... & maintenance. This role may participate in various aspects of technical data and documentation evaluation and review , manufacturing operations, laboratory… more
- AbbVie (North Chicago, IL)
- …of the Medical Affairs-led clinical studies, monitoring overall study integrity and review , interpretation and communication of accumulating data pertaining to ... professional and provider interactions; generation of clinical and scientific data (enhancing therapeutic benefit and value); educational initiatives (medical… more