We are seeking an operational Quality Assurance (QA) Specialist to verify, audit, and enforce day-to-day adherence to established Standard Operating Procedures (SOPs) across our wet-lab and bioinformatics workflows. this role focuses on conducting process audits, monitoring routine operational compliance, handling deviations, and maintaining our active NABL (ISO 15189) and CAP accreditations
Key Responsibilities
- Perform regular on-floor process audits across molecular testing (extraction, qPCR, NGS) and bioinformatics analysis to ensure staff execute procedures strictly per approved SOPs.
- Verify that bench scientists and bioinformaticians accurately maintain operational logs, run-execution records, and chain-of-custody documentation.
- Monitor sample hand-offs, instrument runs, and data transfer checkpoints to catch standard operating variances early.
- Coordinate and assist with routine NABL (ISO 15189) and CAP surveillance audits, re-assessments, and proficiency testing (PT) submissions.
- Conduct internal audits following established checklists to assess continuous readiness for external regulatory inspections.
- Manage non-conformance logging, coordinate with technical teams to execute Root Cause Analyses (RCA), and track Corrective and Preventive Actions (CAPA) to completion.
- Review quality control (QC) check outputs for wet-lab steps (e.g., DNA/RNA yield, library prep QC) and bioinformatic pipelines (e.g., FASTQ metrics, coverage depth, BAM/VCF status checks).
- Audit instrument maintenance logs, reagent lot-to-lot verification records, and calibration status before technical sign-offs.
Experience required
- 23 years working in an accredited clinical or diagnostic laboratory setting.
- Direct experience performing process adherence checks and internal audits against established SOPs.
- Familiarity with molecular workflows (PCR, Sanger, NGS) and basic bioinformatic output files (FASTQ/BAM/VCF).
- Hands-on involvement maintaining NABL (ISO 15189) or CAP compliance.
Kindly share your resume to :
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📌 Executive-Quality Assurance (Chennai)
🏢 Lifecell
📍 Chennai