Quality Assurance Associate
Core
Maintain and support the Quality Management System (QMS) for a specialty laboratory conducting pharmacokinetics and pharmacodynamic assays for clinical trials.
Role type
Quality Assurance Associate (Laboratory)
Builds
Quality-controlled assay data and compliant laboratory operations for clinical research clients
Domain
Life Sciences / Contract Research Organization (CRO) / Laboratory Quality
Deliverable
dashboards & analysis
Required skills
Quality Management Systems (QMS) management, document control, internal auditing, deviation and nonconformity investigation, CAPA coordination, proficiency testing support, equipment qualification and calibration review, data integrity checks, record management (LIMS/database), policy and SOP review
Preferred skills
Laboratory techniques and assays knowledge, early phase clinical trials experience
Technologies
LIMS, Microsoft Office (Word, Excel, PowerPoint), database software
Responsibilities
Conduct document control and coordinate document reviews; perform internal audits; investigate deviations and nonconformities and coordinate CAPA; support proficiency testing and equipment management programs; review policies and SOPs to assure quality; quality assure client protocols and reports; maintain records in LIMS and databases
Seniority
Junior to Mid-level, hands-on IC