- Takeda Pharmaceuticals (Boston, MA)
- …Program Quality, Deviation Management and Serious Breach review board meetings. + Lead complex quality investigations impacting the clinical trial delivery ... Description** **About the role:** Associate Director, Clinical Program Quality Investigations is responsible for ensuring the compliance of deviation management… more
- Medtronic (Mounds View, MN)
- …triage boardunderstand and providing marketing input for identified product concerns entering the CAPA system + CRM Issue Escalation Forum (IEF) to manage ... and innovation, while helping champion healthcare access and equity for all. You'll lead with purpose, breaking down barriers to innovation in a more connected,… more
- Kelly Services (Cincinnati, OH)
- …Scientific is partnering with an established biopharma CDMO to identify a ** Lead Investigator.** The Lead Investigator ensures the investigation outcome and ... concisely so as to be presentable to a regulatory inspector. + **Title:** Lead Investigator + **Location:** Cincinnati, OH metro area + **Hybrid schedule:** 3 days… more
- Glenmark Pharmaceuticals Inc., USA (Monroe, NC)
- Operations BPR Lead Department: Production Location: Monroe, NC START YOUR APPLICATION ... take the competition head-on. POSITION SUMMARY: The Operations BPR Lead is responsible for the real time batch record...area audits, process review and assist with SOP edits, CAPA closure and investigation completion as needed. + Follows… more
- ThermoFisher Scientific (Florence, KY)
- …MasterControl system is used at the site for Risk Assessment, Deviations, CAPA 's, Issue Reviews & guarantee robust corrective/preventive actions are established ... such as Distribution Quality Assurance, auditing, document management & revision, CAPA resolution, Change Control, Discrepant Material and Risk Management in order… more
- Kelly Services (West Chester, OH)
- …Length:** 6-12 Months **Pay Rate:** Commensurate with experience **What You'll Do:** + Lead detailed investigations into manufacturing deviations with a focus on ... clear timelines and defined scopes. + Author comprehensive investigation reports, including issue definition, root cause analysis, and CAPA (Corrective and… more
- Leggett & Platt, Incorporated (Carthage, MO)
- …Own the CAPA Process: Administer our corrective and preventive action ( CAPA ) system, ensuring timely investigations , root cause analysis, and effective ... and upcoming systems. In this pivotal role, you will lead the optimization of our quality systems used for...our quality systems used for data entry, analytics and issue resolution. You will champion continuous improvement efforts based… more
- LGC Group (Petaluma, CA)
- …readiness across the organization. + Investigations : Conduct and review investigations related to Complaints, Deviations, CAPA , OOS, Out of Tolerance, ... taking action. Ensure proactive communication with customers for timely issue resolution and partner concern. Facilitate cross-functional communication effectively.… more
- Kelly Services (Irvine, CA)
- …+ _Lead and/or review, from a Quality perspective, Non-Conformance and CAPA Investigations . Initiate and investigate Corrective and Preventative Actions ... production floor activities (among which IQ/OQ/PQ, Calibration) and product quality investigations and Corrective and Preventive Actions (CAPAs). The Sr. Quality… more
- Wolters Kluwer (Chicago, IL)
- …+ Lead resolution of quality issues with on-market device software; drive investigations related to product nonconformities and implement CAPA plans. + Serve ... locations on the posting). **OVERVIEW** You will be the global product quality lead in support of a broad portfolio of on-market medical devices including Software… more
- Regeneron Pharmaceuticals (Troy, NY)
- …critical decisions pertaining to quality system objectives. + Performs deviation investigations and coordinates CAPA implementation as needed for high-risk ... management and facilitation of the Approved Supplier List (ASL), deviation investigations , CAPAs, supplier audit closures and evidence follow up, support of… more
- Mallinckrodt Pharmaceuticals (Chicago, IL)
- …data to identify trends, track progress, and assess improvement initiatives + Lead investigations and root cause analysis for quality issues, implementing ... Canada, and Australia + Hands-on experience with quality systems including CAPA , deviations, root cause analysis, change control, and compliance in… more
- Lilly (Indianapolis, IN)
- …+ Provide technical and effective process support services for production issue resolution and investigation with proficient data analysis and first principles ... key issues and events and work on the identification and implementation of CAPA plans to address such events and prevent recurrence. **Regulatory Compliance:** +… more
- Lilly (Indianapolis, IN)
- …and Problem-Solving:** + Provide equipment and processing support for production issue resolution and investigation with data analysis and first principles ... issues and events and work on the identification and implementation of CAPA plans to address such events and prevent recurrence. **Regulatory Compliance:** +… more
- Medtronic (Minneapolis, MN)
- …own CAPA (Corrective and Preventive Actions) processes and manage issue escalations to resolution. + Provide troubleshooting and problem-solving support to ... and innovation, while helping champion healthcare access and equity for all. You'll lead with purpose, breaking down barriers to innovation in a more connected,… more
- Rochester Regional Health (Rochester, NY)
- …the resolution of specimen management related issues and queries + Participates in Quality Issue Investigations and CAPA , performs root cause analysis, and ... manager REQUIRED QUALIFICATIONS + 6+ months supervisory or team lead experience is required + Documentation of completion in...related field + 2 + years supervisory or team lead experience, preferred + Clinical Trials or Biorepository Sciences… more
- ThermoFisher Scientific (Fremont, CA)
- …and make data-driven decisions. + Participate in CAPA and non-conformance investigations and champion GMP issue reduction. + Represent the Formulations ... efficiency and delivery goals. As a leader, you will lead all aspects of an inclusive environment, building and...a supervisory role or 1.5+ years in a team lead role. + 7+ years of industry experience in… more
- Sanofi Group (Framingham, MA)
- …Managing contractors for staff augmentation or project roles + Ensuring timely issue escalation to senior management and cross-functional support teams + Partnering ... robust solutions that have minimal downtime and ensure data integrity + Lead development of automation standards + **Training /Deviations /Compliance/Safety:** +… more
- Zimmer Biomet (Braintree, MA)
- …to integration of sites and migration to integrated systems. + Assist and lead audits, both internal and external, to demonstrate compliance with GMP, ISO, CMDR, ... Support coordination of field action activities as needed. + Support Quality investigations . + Manage and facilitate external standard assessments. + Support Annual… more
- Regeneron Pharmaceuticals (East Greenbush, NY)
- …knowledge and oversight for new product introduction, technology transfer, process troubleshooting and issue resolution. + Acts as the technical lead and subject ... consistency after processes are successfully transferred and provides support for investigations . In this role, a typical day might include the following:… more