- Novo Nordisk Inc. (West Lebanon, IN)
- …CAPA that reduce recurrent deviation types Lead and supervise the deviation investigation team, assign deviations based on investigator skill/experience and ... you ready to realize your potential? The Position The Deviation Leader/Coordinator is responsible for the quality and oversight...deviation type, ensure level-loading of investigator workload, and identify and support training and development… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …with Academic Research Organizations (AROs), and meetings with CRO and Investigator Meetings.Support Fair Market Value process in evaluating study budgetsCollect ... document CRO-generated reports, such as site monitoring trip reports and protocol deviation reports and elevate issues to the attention of the supervisor.Compile and… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …with Academic Research Organizations (AROs), and meetings with CRO and Investigator Meetings.Support Fair Market Value process in evaluating study budgets.Collect ... document CRO-generated reports, such as site monitoring trip reports and protocol deviation reports and elevate issues to the attention of the supervisor.Compile and… more
- System One (Bothell, WA)
- Job Title: Deviation Investigator Location: Bothell, WA Compensation: $53.00- $63.86 Type: Contract Overview Leading biopharmaceutical company looking for an ... experience Deviation Investigator . Ideal candidates should have 5+ years of relevant GMP experience and at least 2 years of experience working within quality… more
- Curia (Albuquerque, NM)
- …processing steps. + Provides consistent direction and timely completion of deviation investigations to ensure ongoing consistency for investigation reports that will ... inquiries to meet key timing commitments with well-investigated and well-documented deviation reports. + Work with quality assurance, quality control, operations,… more
- Actalent (Berkeley, MO)
- …client communications and responses to closure through concurrences. + Provide mentorship to deviation management team members. + Lead the team in the absence of ... management. + Assign the daily deviation workload in the absence of management. + Attending...the absence of management. + Attending Tier III for deviation updated when needed. + Takes ownership of Tier… more
- Actalent (Berkeley, MO)
- …client communications and responses to closure through concurrences. Provide mentorship to deviation management team members. Lead the team in the absence of ... management. Assign the daily deviation workload in the absence of management. Attending Tier...in the absence of management. Attending Tier III for deviation updated when needed. Takes ownership of Tier I… more
- Kelly Services (St. Louis, MO)
- …client communications and responses to closure through concurrences. + Provide mentorship to deviation management team members. + Lead the team in the absence of ... management. + Assign the daily deviation workload in the absence of management. + Attending...the absence of management. + Attending Tier III for deviation updated when needed. + Takes ownership of Tier… more
- Insight Global (West Point, PA)
- …* Background in biologics, vaccine, or bulk sterile manufacturing facilities * Deviation Management Investigator including Root Cause Certification. * SAP null ... Description One of our large pharmaceutical clients is actively seeking a Deviation Management Specialist to join the sterile supply incoming materials team located… more
- Novo Nordisk (West Lebanon, NH)
- …that reduce recurrent deviation types + Lead and supervise the deviation investigation team, assign deviations based on investigator skill/experience and ... you ready to realize your potential? The Position The Deviation Leader/Coordinator is responsible for the quality and oversight...deviation type, ensure level-loading of investigator workload, and identify and support training and development… more
- Lilly (Durham, NC)
- …and influence the manufacturing control strategy for their area + Trained as a Deviation Investigator + Development and monitoring of metrics for the area + ... Aid in issue resolution, batch/product approvals, and production schedule execution. + Lead specific activities of the process teams + Requirements (Education, Experience, Training) + High School Diploma or equivalent + Experience: 2+ years Operations or… more
- Bristol Myers Squibb (Bowdre, IL)
- …(APIs and Excipients). **Deviations and laboratory investigation management:** + Act as Deviation Owner or lead investigator for QC incoming packaging ... Provide appropriate level of reporting and communication on the assigned deviation /lab investigations at Quality governance forums. + Present deviations in… more
- System One (East Windsor, NJ)
- Title: Principal Investigator Location: East Windsor, NJ Schedule: M-F Full Time Type: Direct Hire Responsibilities: The Principal Investigator is responsible ... process improvements. + Utilize root cause analysis techniques during deviation investigational process. + Work cross-functionally, to develop and implement… more
- Lilly (Indianapolis, IN)
- … investigations and investigators. Provide advice, review, and guidance to investigator team in deviation investigations (assessment, quality impact evaluation, ... (both internal and external) on quality related matters, and assist in deviation oversight (investigations and change controls) to ensure adherence to regulatory and… more
- Actalent (Berkeley, MO)
- …communications and responses to closure through concurrences. bull Provide mentorship to deviation management team members. bull Lead the team in the absence of ... management. bull Assign the daily deviation workload in the absence of management. bull Attending...the absence of management. bull Attending Tier III for deviation updated when needed. bull Takes ownership of Tier… more
- Takeda Pharmaceuticals (Thousand Oaks, CA)
- …true to the best of my knowledge. **Job Description** Job Title: Compliance Investigator Location: Thousand Oaks, CA **About the role:** You will conduct root cause ... process, compliance, and Continuous Improvement projects and audits. Participate in deviation related meetings and provide feedback, leadership, and support to… more
- Alaka'ina Foundation Family of Companies (Fort Detrick, MD)
- …- 3 and 4) and receive animals for experiments as indicated by the investigator . The candidate shall assist in providing non-routine assignment care, a change in ... is the responsibility of the candidate to inform the investigator , technicians, supervisor and veterinarians of abnormalities, changes, etc.,...VMD, and the TOCOR without delay. Report any SOP deviation to the TOCOR (or designee) as soon as… more
- Ohio University (Athens, OH)
- …studies include both sponsored clinical trials (Phases I-IV) and investigator -initiated research studies (qualitative and quantitative) conducted through the Ohio ... ) for review and approval (ie initial, continuing review, deviation , AE/ SAE , close-out, etc.) + May assist...data per HIPAA and CTRU standards and study Principal Investigator and/or sponsor standards + Maintaining regulatory documents in… more
- Lilly (Concord, NC)
- …area deviation and corrective action discussions as a lead investigator with a cross-functional team from Engineering, Maintenance, Technical Services / ... improvement methodologies and mindset - lean, six sigma, etc. + Documentation, deviation and change management systems (eg, Trackwise. Veeva QualityDocs, Kneat) Eli… more
- Catalent Pharma Solutions (Bloomington, IN)
- …appropriate corrective and/or preventive actions (CAPA) to prevent reoccurrence. The Investigator assists Operations and Quality Assurance teams to determine the ... the initial triage and RPN score of each assigned deviation investigation to ensure it aligns with the company...addressed. + Completes all investigation information into a comprehensive deviation report in a manner that clearly defines the… more
