Jr. Associate Quality

**JOB DESCRIPTION -**

**Hiring for JR ASSOCIATE / ASSOCIATE - QUALITY**

**A. Role Overview**:
**B. Key Responsibilities**:

- **Quality System Management**:

- Assist in the development, implementation, maintenance, and improvement of the laboratory's Quality Management System (QMS) in accordance with NABL, ISO 15189, and other relevant accreditation standards.
- Support the documentation and control of all quality-related records, including SOPs, policies, forms, and reports.
- Ensure all laboratory operations, including pre-analytical, analytical, and post-analytical phases, comply with established quality standards.
- **Audits & Compliance**:

- Conduct regular internal quality audits of various laboratory sections to identify non-conformities and areas for improvement.
- Assist in the preparation and facilitation of external audits (e.g., NABL, regulatory bodies).
- Track and ensure timely closure of corrective and preventive actions (CAPAs) arising from audits, non-conformities, or customer complaints.
- **Data Analysis & Reporting**:

- Collect, analyze, and interpret quality control (QC) data, proficiency testing (PT) results, and other quality indicators.
- Identify trends, anomalies, and potential issues, and report them to the Quality Manager.
- Prepare comprehensive quality reports for management review, highlighting key performance indicators (KPIs) and improvement initiatives.
- **Process Improvement**:

- Participate in Root Cause Analysis (RCA) for deviations and non-conformities.
- Collaborate with laboratory staff to implement corrective actions and process improvements.
- Contribute to continuous improvement projects aimed at enhancing efficiency, accuracy, and patient safety.
- **Training & Awareness**:

- Assist in conducting quality-related training sessions for laboratory personnel to foster a culture of quality and compliance.
- Ensure all staff are aware of and adhere to quality policies, procedures, and safety guidelines.
- **Equipment & Consumables**:

- Monitor and review equipment calibration and maintenance records to ensure proper functioning and compliance.
- Support the qualification and monitoring of reagents and consumables.

**C. Required Skills & Qualifications**:

- **Education**: Bachelor's degree in Medical Laboratory Technology (MLT), Microbiology, Biotechnology, Biochemistry, or a related life science field.
- **Experience**: 2-4 years of experience in a NABL/ISO 15189 accredited diagnostic or pathological laboratory, specifically in a quality assurance or quality control role.
- **Knowledge**:

- Thorough knowledge of NABL and ISO 15189 standards is essential. Knowledge of CAP/CLIA/GLP is a plus.
- Familiarity with laboratory instrumentation, analytical techniques, and common pathology tests.
- **Skills**:

- Excellent attention to detail and a meticulous approach to work.
- Strong analytical and problem-solving skills.
- Proficiency in data analysis tools, especially MS Excel.
- Exceptional written and verbal communication skills (English and local language if applicable).
- Ability to work independently and as part of a team.
- Strong organizational and documentation skills.

**D. General Technical Knowledge (Applicable across all divisions)**:

- **Laboratory Safety & Biosafety**:

- Understanding of universal precautions, handling of biohazardous materials (blood, urine, tissues, cultures).
- Knowledge of proper PPE (Personal Protective Equipment) usage.
- Waste management protocols for biomedical waste.
- Fire safety and emergency procedures.
- Chemical safety and MSDS (Material Safety Data Sheets) understanding.
- **Quality Management System (QMS)**:

- **NABL (National Accreditation Board for Testing and Calibration Laboratories) Standards**: In-depth knowledge of NABL requirements for medical laboratories (e.g., NABL 15189, NABL 112). This is absolutely critical in India.
- **ISO 15189:2012**: Understanding of the international standard for quality and competence in medical laboratories.
- **Internal Quality Control (IQC) & External Quality Assessment (EQA)/Proficiency Testing (PT)**: Principles, interpretation of Levey-Jennings charts, Westgard rules, participation in inter-laboratory comparison programs.
- **Documentation & Record Keeping**: Meticulous maintenance of records, SOPs, logbooks, and quality documents.
- **Calibration & Maintenance**: Principles of instrument calibration, routine maintenance schedules, and troubleshooting.
- **Root Cause Analysis (RCA) & CAPA (Corrective and Preventive Actions)**: Methods for investigating non-conformities and implementing effective solutions.
- **Validation & Verification**: Understanding of method validation and verification processes for new tests/instruments.
- **Specimen Management**:

- Proper collection, labeling, transport, storage, and handling of various biological specimens (blood, urine, CSF, tissues, swabs, etc.).
- Knowledge of anticoagulants, preservatives, and optimal specimen conditions for d