Quality Executive

9 hours ago

Nashik Maharashtra, India Datar Cancer Genetics Limited Full time

**Quality Executive - Molecular Laboratory**

**Location**: Nasik

**Job Summary**:
The Quality Executive for the Molecular Laboratory is responsible for ensuring that all laboratory operations comply with established quality standards, regulatory requirements, and accreditation criteria. This role supports the implementation and maintenance of the Quality Management System (QMS), conducts quality assurance (QA) and quality control (QC) activities, and ensures the accurate documentation and reporting of quality metrics. The Quality Executive plays a key role in maintaining high standards of molecular diagnostic testing and improving overall laboratory efficiency.

**Key Responsibilities**:
**1. Quality Assurance and Compliance**:

- Assist in the implementation and maintenance of the laboratory’s Quality Management System (QMS) to meet CAP, CLIA, NABL, and ISO 15189 standards.
- Monitor laboratory processes to ensure compliance with internal protocols and external regulatory requirements.
- Conduct routine internal audits, document findings, and work with teams to implement corrective actions as required.

**2. Quality Control**:

- Oversee the execution of quality control (QC) protocols for molecular assays, equipment, and reagents to ensure consistent and accurate results.
- Monitor and evaluate QC data to identify trends, deviations, or non-conformities, and recommend corrective actions.
- Collaborate with laboratory staff to troubleshoot QC failures and improve processes.

**3. Document Management**:

- Maintain and update laboratory documentation, including standard operating procedures (SOPs), quality manuals, and records.
- Ensure accurate and timely documentation of quality activities, including incident reports, non-conformance reports, and CAPA logs.
- Assist in the preparation of documents required for regulatory inspections and accreditation purposes.

**4. Training and Competency Assessment**:

- Support training programs for laboratory personnel on quality policies, procedures, and regulatory requirements.
- Assist in conducting competency assessments to ensure that staff adhere to quality and technical standards in molecular diagnostics.

**5. Risk Management and Incident Reporting**:

- Participate in risk assessments for new molecular tests, equipment, and processes.
- Support the incident management process, including root cause analysis and implementation of preventive measures.

**6. Performance Monitoring and Reporting**:

- Compile and analyze quality performance metrics, including turnaround time (TAT), error rates, and customer feedback.
- Prepare quality reports and present findings to laboratory leadership and quality teams for review and improvement planning.
- Perform environmental monitoring in the Laboratory at defined interval.

**7. Support for Regulatory Inspections**:

- Prepare the laboratory for external audits and inspections, including CAP, CLIA, NABL, and ISO assessments.
- Act as a liaison during inspections, providing documentation, responding to queries, and ensuring corrective actions are implemented.

**Qualifications**:
**Education**:

- Master’s degree in Life Sciences, Biotechnology, Microbiology, or a related field.
- Additional certification or training in Quality Management Systems (QMS) or Laboratory Quality (preferred).

**Experience**:

- Minimum of 2-3 years of experience in a quality role within a molecular or diagnostic laboratory.
- Familiarity with molecular diagnostic techniques such as PCR, qPCR, NGS, and other advanced molecular assays is preferred.

**Skills and Competencies**:

- Strong knowledge of quality management systems and regulatory requirements for molecular laboratories.
- Excellent organizational skills, with the ability to manage multiple tasks and maintain detailed documentation.
- Analytical and problem-solving skills to evaluate QC data and troubleshoot quality issues.
- Effective communication skills, both written and verbal, to interact with laboratory staff and external auditors.
- Proficiency in laboratory information systems (LIS) and quality management tools.

**Work Environment**:
The role is based in a molecular diagnostic laboratory and requires adherence to laboratory safety protocols, including handling potentially infectious materials. The Quality Executive will work closely with laboratory staff, quality teams, and regulatory bodies to ensure continuous quality improvement.

**Why Join Us?**

As a Quality Executive in our Molecular Laboratory, you’ll play a critical role in upholding diagnostic excellence and supporting cutting-edge molecular testing. Join our team to make a meaningful impact on patient care while advancing your career in a dynamic and innovative environment.

**Datar Cancer Genetics is an equal opportunity employer and values diversity in the workplace.**

**Job Types**: Full-time, Permanent

Schedule:

- Day shift

**Experience**:

- total work: 2 years (preferred)

Work Location: In person

E

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