- Legend Biotech USA, Inc. (Raritan, NJ)
- …immunotherapy in the treatment of multiple myeloma.Legend Biotech is seeking Sr. Investigator Compliance Specialist as part of the Technical Operations team based in ... Raritan, NJ. Role OverviewThe CAR-T Compliance Auditor (Sr. Investigator ) will be a key member of the Technical...manufacturing processes. This role combines deep expertise in CAR-T process technologies with a strong focus on compliance auditing,… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …Affairs to facilitate the implementation of a risk-based quality management process fully embedded through trial design, execution and submission including all ... Critical Incidents including, respective escalation and the CAPA Management Process for the respective business areas.Responsibilities:Leadership and Project Management:Lead… more
- PDS Tech Commercial, Inc. (Indianapolis, IN)
- **Now Hiring: Process Expert Deviation Investigator | Onsite in Indianapolis** _Pay: $30 - $40/hour (based on skills and qualifications) | Monday-Friday, ... in partnership with a global leader in pharmaceutical manufacturing, is seeking a ** Process Expert Deviation Investigator ** to join their team in… more
- Kelly Services (Cincinnati, OH)
- **_Experienced in Deviation Remediation?_** **Lead Pharma Investigations in a 6-12 month Contract Role w/ Benefits - Apply Now!** **Now Hiring:** Lead Investigators ... - Pharma Manufacturing ( Deviation Management) **Location:** Cincinnati, OH (onsite) **Duration:** 6-month contract **Pay Rate:** $40-45/hour + benefits Kelly… more
- Lilly (Pleasant Prairie, WI)
- …make life better for people around the world. **Job Title:** **Utilities Process Engineer** **Organization Overview:** The Utilities Process Engineer will join ... and Project Engineering team as the site Subject Matter Expert (SME) at the Lilly Kenosha County (LKC) campus...and Utilities systems, both GMP (PW, WFI, Clean Steam, Process Compressed Air, etc.) and non-GMP (Plant Steam, Chilled… more
- Dana-Farber Cancer Institute (Brookline, MA)
- The Regulatory Coordinators (RC) works under the direction of the Principal Investigator (s), Clinical Research Manager and / or directly for the Clinical Trials ... Core with other required hard copy submissions to FDA, yearly Principal Investigator Worksheet (PIW) updates for DFCI physicians participating in National Cancer… more
- Lilly (Concord, NC)
- …area deviation and corrective action discussions as a lead investigator with a cross-functional team from Engineering, Maintenance, Technical Services / ... readiness programs (eg Material procurement and definition, training programs, process excellence, continuous improvement, and capacity planning). The person in… more
- ThermoFisher Scientific (Alachua, FL)
- …Reports (CSRs), Informed Consent Forms (ICFs), Case Report Forms (CRFs), protocol deviation decisions and other clinical documents as required for the conduct of ... committee if applicable; medical training of site staff at Investigator meetings; CRA training in new indications + Ensure...to questions from sites /IRBs RAs, eligibility and protocol deviation decisions will be harmonized across medics **Keys to… more
- Glenmark Pharmaceuticals Inc., USA (Monroe, NC)
- …procedures (SOPs). + Displays ability to achieve Glenmark Monroe QE investigator certifications for product/ process /testing/facility issues with product and ... the Pharmaceutical Industry. This role is mainly responsible for completing deviation investigations, OOS/OOT and CAPA development related to EM and microbiological… more
