- Insmed Incorporated (San Diego, CA)
- …teams, contract research organizations (CROs), and external vendors to prepare, review and finalize clinical study documents and plans Contribute to scientific ... design planning through final reporting of results Provide scientific input and review of clinical study data, support in assessing medical monitoring reports, study… more
- AUROBINDO (Durham, NC)
- …world to live in.Job OverviewThis position is responsible for the technical review of raw data, qualification protocols, Certificate of Analyses and other technical ... also reponsible for anyother compliance task assigned by the department Head. ResponsibilitiesTechnical review of raw data for the QC groupTechnical review of… more
- Credence (MD)
- …(CONUS) and outside the contiguous United States (OCONUS). Requirements Develop, review , and provide recommendations for classified and unclassified PM PNT products ... the proceedings of these meetings and provide recommendations. (CDRL A010) Review , recommend, and update program documentation supporting the acquisition process and… more
- Cipla (Hauppauge, NY)
- …supporting manufacturing processes, with a particular focus on audit trail review , data integrity, and overall GxP compliance. Responsibilities: Perform detailed ... actions in the audit trails and escalate as needed. Review user activity logs within the batch record systems...actions are secure, traceable, and compliant with regulatory standard. Review of the batch records (manufacturing and packaging) to… more
- Cipla (Central Islip, NY)
- …finished drug products. Responsibilities include but are not limited to GMP documentation review and supporting other QA functions as needed. In this role, the ... associate II" include but are not limited to the following: Review documentation for manufacturing activities associated with commercial, development, and… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …provide guidance and determine immediate path forward for manufacturing quality issues. Review of all documentation, in accordance with Good Documentation Practices ... (GDP). Review , revise, or draft Standard Operating Procedures (SOPs)Support processes...ensure sterility of the product/process is not compromised.Support batch review & material release in SAP for In-house reagents.Support… more
- Cipla (Fall River, MA)
- …duties for this position include but are not limited to the following : Review of batch manufacturing/packaging record. Review of engineering records such as ... and PM records, pest control records and contractor related functions. Review and approval of manufacturing/engineering non-conformances. Review and approval… more
- Credence (Wright-Patterson AFB, OH)
- …not limited to the duties listed below Perform planning and design review /approvals for multi-phase new construction, renovations, and improvement projects for real ... and HAF Fire Protection issues and initiatives. Prepare, develop or review design calculations, Life Safety analysis, cost estimates, schedules, underlying analysis,… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …strategic and planning alignment across regions and functions and supports review of Local Country/Regional Medical Affairs activities when applicable. Provide ... Operations and other cross-functional and regional stakeholders.- Provides support in review of investigator-initiated studies (IIS) and may serve as deputy compound… more
- Cipla (Fall River, MA)
- …for this position include but are not limited to the following: Review of batch manufacturing/packaging records. Release of raw materials, packaging materials and ... finished products through approval of respective COA. Review of engineering records such as temperature and humidity data calibrations, preventive maintenance… more
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