- Unither Pharmaceuticals (Rochester, NY)
- …of this role may include assisting with documentation archive, filing, and label issuance . Issuance of working batch cards for manufacturing, packaging, ... QA Operations Documentation Specialist Who we are? We are a French...team. This position is also responsible for ensuring completed batch documentation is scanned into the system and sent… more
- Astellas Pharma (Westborough, MA)
- **Sr Manufacturing Specialist , Production Planning** Do you want to be part of an inclusive team that works to develop innovative therapies for patients? Every day, ... headquartered in Massachusetts. Astellas is announcing a **Sr Manufacturing Specialist , Production Planning** opportunity at their **Astellas Institute for… more
- University of Pennsylvania (Philadelphia, PA)
- …as needed. + Assisting the QA Compliance group as needed to help with master batch record issuance and external audits, DFPs, CAPAs review. + Assisting Manager ... and resources, and much more. Posted Job Title Quality Assurance Specialist (Regulatory) CVPF(Center for Cellular Immunotherapy) Job Profile Title Research… more
- Catalent Pharma Solutions (Chelsea, MA)
- …Role** + Oversight (with limited supervision) of production activities, including area clearance, issuance and review of batch records, and making decisions on ... **Quality Assurance Specialist II - Night** **Position Summary:** Catalent is...review and approval of SOPs, Protocols, Reports, and Master Batch Records for continuous improvement; + Initiation of Discrepancies,… more
- Kedrion Biopharma (Melville, NY)
- …Review within required timeframe assigned to specific products and intermediates. + Support batch record and logbook issuance as well as retention and archiving ... immunology, neurology, and transfusion medicine. The Quality System and Compliance Specialist has a robust understanding of applicable CGMP regulations and standards… more
- Gilead Sciences, Inc. (Foster City, CA)
- …and material issuance /movement. Verifies API issuances are in alignment with batch records to support GxP lot tracing requirements. + Coordinates with Global ... change orders, or other delaying conditions. + Establishes sequence and lead-time of each batch to meet CMO release dates. + Updates ERP system data to report… more
- Editas Medicine (Cambridge, MA)
- …documentation management system. + Facilitate the creation, revision, distribution, and issuance of controlled documentation (master batch records, logbooks, ... in our Quality organization. Characterizing Your Impact: As the Senior QA Specialist , you will: Documentation: + Format new and revised documents submitted for… more
- Kelly Services (Cambridge, MA)
- …documentation management system. + Facilitating the creation, revision, distribution, and issuance of controlled documentation (master batch records, logbooks, ... Kelly Science is seeking a Senior Quality Assurance Specialist to join a document control & quality systems department of a growing client located in Cambridge, MA.… more
- ThermoFisher Scientific (Detroit, MI)
- …bioproduction and culture media. **How will you make an impact?** The Quality Specialist II will report to the Quality Assurance Supervisor. The position's focus is ... as applicable. + Lead and host site's quality management reviews including issuance and delivery. + Own the Detroit Site's internal audit program, responsible… more
- CGI Technologies and Solutions, Inc. (San Diego, CA)
- …application. * Communicate with the cashiers office and coordination with Passport Specialist assigned to special task of re- issuance of applications. * ... constantly applying laws, regulations and procedures pertaining to the issuance of a US Passport. * Use TDIS and...including: Return to Sender (RTS), Rewrites and Re-issues, and re- batch into the system. * Assist with various special… more
- CGI Technologies and Solutions, Inc. (Honolulu, HI)
- …resolve application discrepancies, including: Return to Sender, Rewrites and Re-issues, and re- batch into the system. * Review Passport application data to ensure ... * Handle complaint letters/phone calls. * As requested by DOS Passport Specialist , perform administrative review on suspended applications. * Verify all applications… more
- Technical and Project Engineering LLC (TAPE) (Dallas, TX)
- …resolve application discrepancies, including: Return to Sender, Rewrites and Re-issues, and re- batch into the system. * Review Passport application data to ensure ... * Handle complaint letters/phone calls. * As requested by DOS Passport Specialist , perform administrative review on suspended applications. * Verify all applications… more
- CGI Technologies and Solutions, Inc. (Boston, MA)
- …resolve application discrepancies, including: Return to Sender, Rewrites and Re-issues, and re- batch into the system. * Review Passport application data to ensure ... * Handle complaint letters/phone calls. * As requested by DOS Passport Specialist , perform administrative review on suspended applications. * Verify all applications… more