Clinical Quality Assurance, Specialist II
$80k - $95kScorpion Therapeutics
The Clinical Quality Assurance Specialist will support GCP and Quality Assurance activities to ensure compliance with GCP standards, including investigator audit programs, risk management plans, regulatory inspections, continuous improvement metrics, and quality events—collaborating cross-functionally to uphold clinical trial quality and regulatory compliance. Responsibilities Develop and maintain clinical quality study risk plans and keep updates in the Quality Management System. Collect site metrics for investigator site audit selection and analyze/report audit finding trends. Support and lead internal audits. Support QMS (Veeva) audit entry and dashboard. Perform SOP review. Facilitate ongoing quality improvement through communication of audit results, CAPAs, and other quality events. Issue, track, and complete deviations, SCARs, and CAPAs. Support clinical study programs with GCP compliance, as needed. Support health authority inspections. Communicate serious/critical compliance risks to senior management (manage report of Serious Breaches). Stay current on related quality legislation and compliance issues. Support GxP risk management analysis efforts (primarily GCP) and risk identification (asset/IP, therapeutic area, clinical study/site, vendors). Identify KPIs for risk monitoring from internal/external sources. Communicate risk mitigations and activities to relevant teams. Requirements Bachelor’s degree in a science discipline (required). 3 years relevant experience in a regulated environment (preferred QA/auditing/GCP). 2 years relevant experience in GCP with Quality/Compliance oversight. Strong knowledge of GCP and FDA, European regulations, and ICH guidelines. Proficiency with Veeva, Microsoft Word, PowerPoint, and Excel. Occasional travel to San Diego, CA; Verona, WI; Pasadena, CA. Preferred Experience with electronic document management systems in regulated environments (Veeva). Knowledge of/beneficial experience with AI or building AI models. Compensation (California) $80,000–$95,000 USD. #J-18808-Ljbffr Scorpion Therapeutics
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Mindlance
Santa Monica, CA3 days ago - ...Quality Assurance Specialist Under the direction of the Chief Quality Assurance Officer, the Quality Assurance Specialist is responsible for... ...documentation accuracy. Using the audit tool, conduct regular non-clinical and clinical quality checks on charts as directed and per...Work at officeFlexible hours
Southern California Health and Rehabilitation Program
Los Angeles, CA3 days ago - ...globally expanding, industry-leading organization. As a Quality Assurance (QA) Specialist , you will be responsible for ensuring the quality and reliability... ...of the position Must be willing to submit up to a LEVEL II background and/or security investigation with a...Work at officeLocal areaRemote work
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City/State: White Plains, New York Department: Quality Assurance_1 Work Shift: Day Work Days: MON-FRI Scheduled Hours: 9 AM-5 PM Hours... ...Rate/Range: $83,239.46 - $124,880.93 Job Summary The Clinical Quality Specialist assesses and recommends quality and clinical performance...Live inWork at officeShift work- ...About the job Quality Assurance Specialist Job Summary We are seeking a Quality Assurance Specialist to ensure our products and operations comply with all applicable U.S. federal, state, and local regulations. This role will play a critical part in bridging...Local area
DHD Consulting
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Los Angeles, CA5 days ago- ...Job Description Job Description Position Title: Quality Assurance Specialist Reports To: Substance Use Disorder Program Director Status: Full-Time - Union Position Summary: Clinica Romero’s Quality Assurance Specialist will work under...Full timeInternshipWork at office
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Los Angeles, CA8 days ago $28 - $34.65 per hour
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South Gate, CAa month ago- University of California - Los Angeles Health seeks a QA Officer to oversee GMP QA compliance in the HGCTF. The role focuses on document control, OOS/deviations, CAPA, change control, and release of reagents per procedures. The incumbent will write and approve Master Production...
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$34.14 - $36.05 per hour
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...break. Position Summary The QA Specialist is responsible for ensuring compliance with... ...requirements while maintaining high-quality standards. This position plays a critical... ...Train QA Department staff on MTC quality assurance procedures. Develop QA training programs...Contract workWork at officeLocal areaWorldwideWeekend workMutual Trading
El Monte, CA4 days ago$72k - $92k
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El Monte, CA5 days ago
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