The Quality Jr Associate / Assocaite will play a crucial role in maintaining and enhancing the quality management system (QMS) within our large pathological laboratory. This position is responsible for ensuring strict adherence to national and international quality standards (e.g., NABL, ISO 15189, CAP, GLP), regulatory requirements, and internal standard operating procedures (SOPs) to deliver accurate and reliable diagnostic results. The ideal candidate will have a keen eye for detail, a strong understanding of laboratory processes, and a commitment to continuous improvement.
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:
In-depth understanding of Quality Management Systems (QMS) and their application in a diagnostic laboratory setting.
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.
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 different tests.
Pre-analytical variables that can affect test results (e.g., fasting status, time of collection).
Laboratory Information Management System (LIMS):
Proficiency in using LIMS for patient registration, test ordering, result entry, validation, and reporting.
Understanding of data integrity and confidentiality.
Basic Computer Skills:
Proficiency in MS Office (Word, Excel, PowerPoint) for documentation, data analysis, and presentations.
Ethical Guidelines:
Adherence to patient confidentiality (HIPAA/data privacy principles), professional ethics, and good laboratory practices (GLP).
E. What We Offer:
Opportunity to work with a leading and technologically advanced pathological laboratory.
A dynamic and supportive work environment.
Continuous learning and professional development opportunities.
Competitive salary and benefits package.
A chance to contribute directly to improving patient health outcomes.
Job Types: Full-time, Permanent