- Legend Biotech USA, Inc. (Raritan, NJ)
- …or final product samples submitted to the QC laboratories.Perform peer review /approval of laboratory data.Utilize electronic systems (LIMS) for execution and ... documentation of testing.Create, review and approve relevant QC documents, SOP's and WI's.Perform tasks in a manner consistent with the safety policies, quality… more
- Cipla (Central Islip, NY)
- …will be Monday to Friday Responsibilities/ Accountabilities Prepare and review Change Controls, Technical Deviations, Methods, Specifications, COAs, Batch Records, ... to provide recommendations or conclusions. Strict attention to detail and ability to review and edit content for compliance, clarity, and proper use of terminology.… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …through completion.Schedule and participate in the site change control review board meetings.Manage change control metrics reporting.Collaborate with functional ... manner consistent with the safety policies, quality systems and cGMP requirements. Review change controls, SOPs, and other documentation.Require minimal direction to… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …protocol profiles, final protocols and amendments-Participate in protocol and amendment review .Contribute to the development of and oversee delivery timelines of ... Lead).-Monitor study budget against trial progress and Inform Finance of deviations- Review and approve Vendor invoices, including investigator grants and pass… more
- Cipla (Hauppauge, NY)
- …assigned and follow company policies, safety requirements, cGMP and SOP's. Review of online batch records, area/equipment logbooks, calibration/PMP records etc. ... material generated during batch process and accountability in the batch record. Review of engineering records (temperature and humidity data, calibration reports and… more
- BioAgilytix (San Diego, CA)
- …new analytical techniques and technologies and lead their implementation. Review analytical instrument and equipment calibration, qualification and maintenance ... records.Perform statistical analysis.Write and review reports and prepare SOPs.Fulfill the role of Bioanalytical Project Manager (BPM)/Principal Investigator (PI)… more
- Novo Nordisk Inc. (Boulder, CO)
- …but is not limited to training & development, performance management/ review & development planning, talent recruitment/selection, managing employee relations, ... change management, planning/organizing & managing execution required Demonstrated ability to review complex organizational plans & provide any required or necessary… more
- Syner-G BioPharma Group (Boston, MA)
- …activities for Basecamp and client Tech Transfer projects, including generation, execution, review , and closure of validation life cycle documents (RA, VP, IQ, OQ, ... PQ, TM, VR).Write, review , and revise a variety of Installation, Operation, and Performance qualification/verification related documents, including any or all of the… more
- Tris Pharma (Monmouth Junction, NJ)
- …and experience level relative to requirements of the position and a review of related industry standards and internal equity.Anticipated salary range for permanent ... and experience level relative to requirements of the position and a review of related industry standards and internal equity.Additional benefits: In addition to… more
- Insmed Incorporated (San Diego, CA)
- …Gdoc. Etc.) Provide real-time oversight and support during test execution Review executed protocols and provide test protocol deviation assessment and resolution ... in the CSV SharePoint site, managing CSV documents in Veeva, routing documents for review and approval in Veeva etc. This role will participate in on site Change… more
