Quality Assurance Specialist – Genomics Laboratory
Location: Bengaluru
Employment Type: Full-time
Job Overview
MedGenome Labs Ltd. is seeking a Quality Assurance Specialist with expertise in genomics laboratory processes to support the quality assurance and compliance needs of our US-based genomics laboratory from India. This is an excellent opportunity for professionals with 3–4 years of relevant experience in regulated environments, focusing on quality systems, regulatory compliance, and continuous process improvement in molecular diagnostics or genomics workflows.
Key Responsibilities
Quality Assurance and Compliance
- Implement laboratory policies and procedures aligned with US regulatory standards and state-specific requirements.
- Document efforts for internal audits, inspections, and proficiency programs to ensure compliance with US regulations.
Collaboration and Problem-Solving
- Collaborate with US-based teams to address quality issues through root cause analysis and corrective/preventive actions (CAPA).
- Communicate quality updates effectively to foster a culture of innovation and accountability.
Process and Documentation Management
- Manage records, including SOPs, laboratory manuals, QMS documentation, and validation protocols.
- Support gap analysis, risk management, document control, and process improvement tailored to genomic operations.
Regulatory and Technical Support
- Prepare the US laboratory for regulatory audits and inspections by ensuring full compliance with US research and quality standards.
- Provide end-to-end quality system support for processes like next-generation sequencing (NGS), sample chain of custody, library preparation, sequencing, qPCR, and other genomic technologies.
- Participate in weekly US time zone meetings and audits as required.
Qualifications
Education
- Bachelor’s or Master’s degree in Biology, Molecular Biology, Genetics, Genomics, Chemistry, or a related field.
Experience
- 3–4 years of experience in a genomics or molecular diagnostics laboratory or a quality assurance role in a regulated environment.
- Hands-on experience with regulatory audits or inspections, including NABL, ISO standards like ISO15189, or state agencies.
- Proficiency in quality management systems and US regulatory standards for genomic workflows.
Skills
- Strong understanding of QA principles, including CAPA, root cause analysis, and proficiency testing.
- Excellent written and verbal communication skills with high attention to detail.
- Expertise in project management and process improvement for genomic workflows.
- Proficient in Microsoft Word, Excel, and related tools for efficient data documentation and analysis.
Preferred Qualifications
- Direct experience in quality assurance for genomics laboratory processes or molecular diagnostics.
- Knowledge of regulated environments with a focus on compliance and process improvement in genomic technologies.
Why Join MedGenome Labs?
- Work with industry leaders in genomics and molecular diagnostics.
- Contribute to cutting-edge genomic workflows and regulatory compliance.
- Collaborate with a global team committed to innovation and quality.
How to Apply
Email your CV to careers-us@medgenome.com.
Corporate Office
MedGenome Labs Ltd.
Sy. Nos. 94/1C and 94/2, Tower 1, 3rd Floor,
Veerasandra Village, Attibele Hobli, Electronic City Phase-1,
Bangalore, Karnataka – 560100
Keywords: Quality Assurance Specialist, Genomics Laboratory, Molecular Diagnostics, CAPA, NGS, Regulatory Compliance, ISO15189.
