Hired by Matrix, Inc · 4 hours ago
QC/QA Investigator
Durham, NC
Contract
Onsite
Senior Level
$50/hr - $52/hr
5+ years expHired by Matrix, Inc is a certified technology solutions and compliance consulting services company, and they are seeking a QC/QA Investigator. The role involves owning the authorship, review, and approval of GMP investigations, ensuring timely closure, sound root cause analysis, and supporting lot disposition and inspection readiness.
Human ResourcesMarketingStaffing Agency
Responsibilities
Own the authorship, review, and approval of GMP investigations
Lead OOS, LER, deviations, and CAPAs across QC labs and manufacturing
Ensure timely closure, sound root cause, and defensible product impact assessments
Support lot disposition and inspection readiness
Author complete GMP investigations for OOS, LER, deviations, and atypical results in QC and manufacturing environments
Perform root cause analysis using audit trails, batch records, logbooks, calibration records, and trend data
Review and approve investigations written by peers and SMEs for technical accuracy, compliance, and clarity
Evaluate product impact and support risk based lot disposition decisions
Lead CAPA development, execution, and effectiveness checks
Review Empower, LIMS, Vi-CELL XR, TOC, and other QC system audit trails for data integrity
Investigate equipment, method, reagent, and analyst related failures
Review DS and DP batch records for GMP compliance and deviation linkage
Approve change controls related to QC methods, instruments, and manufacturing processes
Support deviation review boards and quality governance meetings with clear data driven summaries
Ensure investigations meet FDA and global regulatory expectations, including 21 CFR Part 11 and ALCOA+
Maintain inspection readiness and respond to auditor questions on investigations and CAPAs
Qualification
Required
Bachelor's degree in science or engineering. Advanced degree preferred
5 plus years of GMP QA or QC experience in pharmaceuticals, biologics, or sterile manufacturing
Demonstrated experience authoring and approving OOS, LER, and deviation investigations
Strong knowledge of GMP regulations, data integrity principles, and investigation best practices
Hands on experience with TrackWise and Veeva Vault
Proficiency with Empower and LIMS audit trail review
Experience supporting lot disposition with open or recently closed investigations
Preferred
Biologics, aseptic processing, or sterile manufacturing experience
Investigation of laboratory instruments, chromatography systems, and critical utilities
Participation in regulatory inspections and audit responses
SMR and QMR trend analysis and governance support
Company
Hired by Matrix, Inc
Hired by Matrix is a staffing and recruiting company specializing in administrative, clerical, and marketing staffing services.
201-500 employees
Funding
Current Stage
Growth StageLeadership Team
S
Sharon Olzerowicz
President/CEO
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