MedGenome is looking for an experienced Quality Assurance Specialist to support quality assurance and compliance for its US-based genomics laboratory. This position requires 3–4 years of experience in quality systems, regulatory compliance, and continuous process improvement within a genomics or molecular diagnostics laboratory.
Job Details
Location: Bengaluru
Employment Type: Full-time
Corporate Office Address: 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
Key Responsibilities
Quality Systems and Compliance
- Assist in implementing laboratory policies and procedures aligning with US regulatory standards and state-specific requirements.
- Support documentation for internal audits, inspections, and proficiency programs to ensure compliance with US genomic workflows.
- Perform root cause analysis, corrective actions, and preventive actions (CAPA) for quality issues, collaborating with US-based teams and external stakeholders.
Process Improvement and Documentation
- Contribute to project management tasks such as gap analysis, risk management, and document control tailored to genomic laboratory operations.
- Maintain comprehensive records of QA activities, including SOPs, laboratory manuals, and validation protocols.
- Provide end-to-end QA support for genomic processes like next-generation sequencing (NGS), qPCR, and other genomic technologies.
Audit Preparation and Communication
- Assist the US lab in preparing for regulatory audits and inspections, ensuring compliance with US research and quality standards.
- Communicate quality-related updates to US teams, promoting a culture of accountability, innovation, and adherence to quality standards.
Skills and Qualifications
Required Skills
- In-depth knowledge of QA principles, including CAPA, root cause analysis, and proficiency testing for genomic assays.
- Exceptional written and verbal communication skills with attention to detail and organizational ability.
- Proficiency in project management and process improvement for genomic workflows.
- Strong collaboration skills across departments, with the ability to communicate technical concepts effectively.
- Expertise in Microsoft Word, Excel, and other tools for documentation and analysis of QA data.
Preferred Qualifications
- Hands-on experience in quality assurance for genomics laboratory processes or molecular diagnostics.
- Experience working in regulated environments with a focus on compliance and process improvement for genomic technologies.
Education and Experience
Education
Bachelor’s or Master’s degree in Biology, Molecular Biology, Genetics, Genomics, Chemistry, or related field.
Experience
- 3–4 years of experience in a genomics or molecular diagnostics clinical laboratory, or quality assurance in a regulated environment.
- Hands-on experience with regulatory audits or inspections (e.g., NABL, ISO standards like ISO 15189, or state agencies).
- Familiarity with quality management systems, process improvement, and US regulatory standards for genomic workflows.
How to Apply
Please send your CV to careers-us@medgenome.com.
