- Catalent Pharma Solutions (Greendale, IN)
- **Site Deviation Investigator ** **Position Summary** + **Work Schedule:** Monday to Friday, business hours + 100% on-site in Greendale, IN Greendale is one of ... nutraceuticals via confection to enhance wellness for all consumers. The **Site Deviation Investigator ** will be independently responsible for the efficient and… more
- Actalent (Greenville, NC)
- Job Title: Deviation InvestigatorJob Description The Deviation Investigator is responsible for identifying, documenting, investigating, and resolving ... of all deviations, investigations, and corrective actions. + Prepare and present deviation reports to management and regulatory authorities as required. + Ensure… more
- ThermoFisher Scientific (St. Louis, MO)
- …management systems **A day in the Life:** . Manage Major deviation investigations, including assembling investigation teams, leading root cause analysis, development ... and documentation (TrackWise, Master Control, or equivalent) * Experience in deviation investigations, CAPA, change control, and root cause analysis * Proficient… more
- Glenmark Pharmaceuticals Inc., USA (Monroe, NC)
- …crucial direction of the Head of Operations and the Head of Quality Systems, the Deviation Investigator will play a pivotal role in our company's growth by ... owning and investigating all Manufacturing-related deviations. The Deviation Investigator will collaborate with cross-functional stakeholders to perform simple… more
- Lilly (Pleasant Prairie, WI)
- …+ Escalate concerns/issues and develop mitigation plans. + Trained as a lead investigator , deviation assessor and approver. Can act as a technical reviewer ... to deliver on new manufacturing investments and new pioneering technologies. The Deviation Mentor is a member of the LKC Quality organization that educates,… more
- Bristol Myers Squibb (Bothell, WA)
- …records through the electronic quality record management system at BMS Bothell, WA. The Deviation Investigator on the MSAT team is an individual contributor role ... and determine the associated corrective action to prevent the deviation from reoccurring This person will be a key...RFT (right first time) and on-time phase completion, including deviation closure by the original due date + Immediately… more
- Astrix Technology (Springfield, MO)
- …and compliant closure. + Provide coaching and training to staff on deviation investigations, RCA methodologies, and investigator qualification. + Perform and ... **QC Deviation Specialist III** Quality Control Springfield, Missouri, US...leading global CDMO, is looking to hire a QC Deviation Specialist III to join their growing team in… more
- Kelly Services (Greensboro, NC)
- **Position Title:** Investigator , Manufacturing Compliance (Contract) **Location:** Winston-Salem, NC **Position Summary:** The Investigator is responsible for ... and regulations while ensuring team compliance in all activities. The Investigator leads the initiation, investigation, and resolution of process deviations, Change… more
- Takeda Pharmaceuticals (Round Lake Beach, IL)
- …of my knowledge. **Job Description** **About the role:** The Lead Investigator will initiate and execute deviations in support of Manufacturing. Responsibilities ... improve quality, and provide new product support, as needed. Lead or support Deviation Free Initiatives + Work closely with other QA departments and manufacturing… more
- Insight Global (Boston, MA)
- Job Description Insight Global is looking for a QC Analytical Investigator to sit on-site at a brand new facility in the beautiful Seaport district of Boston ... with previous experience authoring, reviewing and editing risk assessment, CAPA and deviation documents . Effective communicator with ability to influence a group of… more
- University of Washington (Seattle, WA)
- …Office (RSO) to meet all regulatory and compliance submissions involving editing of investigator initiated protocols and consent forms as well as submission of NCI ... **Duties:** 65% Guide MDs with all aspects of the development of investigator initiated studies. Where required, assist MDs with retrospective chart review studies… more
- Amgen (Holly Springs, NC)
- …EHSS, and Quality. This position is responsible for ensuring deviation investigations are successfully conducted and documented while driving improvements ... in the investigation process. + Manage Major deviation investigations, including assembling investigation teams, leading root cause analysis, development of CAPAs,… more
- ThermoFisher Scientific (Austin, TX)
- …expertise, experience and training. Working under the direction of the chief physician/ investigator and the Staff Paramedic in the Clinic, ensures subject safety, ... documenting, and treating AEs, or directly deferring to the physician/ investigator as needed. **Essential Functions and Other Job Information:** **Essential… more
- University of Pennsylvania (Philadelphia, PA)
- …proposals, and research related presentations. Works closely with the Principal Investigator , manager, and study team to identify problems and develop solutions. ... needed and monitor results. Responsible for study coordination for investigator -initiated studies, multi-center research studies, and patient-oriented clinical and… more
- Kelly Services (West Point, PA)
- …values + Prepares scientific slides, attends and presents protocol information at Investigator Meeting + Scientific lead on Clinical Trial Team (CTT) + Reviews ... Supports publications/presentations as needed + Reconciles and review all protocol deviation classifications in SPECTRUM + Assesses and prepares protocol … more
- ThermoFisher Scientific (Suwanee, GA)
- …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
- University of Miami (Miami, FL)
- …standards and clinical credentials as delegated by the Principal Investigator .6. Monitors, documents, reports, and follows-up on study unanticipated/adverse events ... in implementing protocol amendments under direct supervision of the Principal Investigator .8. Assists with study orientation and protocol related in-services to… more
- UPMC (Pittsburgh, PA)
- …Research Coordinator (CRC) will work under the direction of the clinical Principal Investigator (PI) and Co- Investigator . We are currently recruiting a CRC to ... level. This includes ensuring inclusion/exclusion criteria are applied without deviation , coordinating patient visits, managing sample collection logistics, and… more
- Glenmark Pharmaceuticals Inc., USA (Monroe, NC)
- …the Pharmaceutical Industry. This role is mainly responsible for completing deviation investigations, OOS/OOT and CAPA development related to EM and microbiological ... on updating SOPs, WIs, and OJT + Complete and maintain certified investigator training requirements. Perform investigation of the quality events assigned using root… more
- Dana-Farber Cancer Institute (Boston, MA)
- …(RC) works under the direction of the Breast Oncology Principal Investigator (s), Regulatory Operations Manager, Clinical Research Manager and / or directly ... of assigned study monitoring and auditing visits with study coordinator, Investigator , DF/HCC ODQ, Industry Sponsors, and third-party auditors + Track and… more