JOB DESCRIPTION:

Name of the Position: Manager - Lab Operations

Qualification: B Sc/M Sc in Medical Lab Technology/Biochemistry/Biotechnology/Microbiology

Experience: 8 to 12 Years

Reporting: Director - Laboratory

Location: Delhi & Chennai

No of Positions: 2

Competencies:

- Knowledge in clinical research related quality improvement

- Good interpersonal skills

- Commitment towards quality

- Result orientation

- Hardworking with a zeal to learn new technologies

Roles & Responsibilities:

- Monitoring if the TAT is being maintained strictly

- Monitoring the TAT of the samples transferred to Hyderabad from other locations

- Coordinate with all departments- HODs about process flow from sample receipt to report delivery

- Addressing the issues from customer care and sales teams

- Monitor EQAS on monthly basis

- To monitor the branch stock and aid in smooth functioning

- Prepare and implement duty roster of employees

- To procure kits from vendors for smooth functioning

- To coordinate with Service engineers- and plan preventive maintenance of all machinery accordingly

- To know and implement the quality systems as per NABL112, ISO15189, CAP Guidelines, GLP Guidelines and relevant SOPs wherever applicable

- Guide technicians in quality documentation

- Processing samples in the absence of technicians in the department

- To verify clinical biochemistry test results before releasing. To give opinions and interpretations for test results.

- As Biochemist supervise manage and lead the deportment of Biochemistry CRL in absence of section head

- To review SOPs, validation protocols and reports as and when required

- To ensure the work area clean and sterile adherence to prescribe biosafety procedures.

- Documentation as per NABL 17125 guidelines

- Training in Molecular Biology department: Extraction of DNA and RNA from patient samples and amplification of gene of interest using PCR

- Training in Flow cytometry Implementing quality control systems and monitoring the overall functions of the Clinical Reference Lab as per GLP, NABL, CAP, USFDA and WHO guidelines

- Proficient in maintaining documents as per US FDA, ISO 15189 standards and CAP Guidelines

- Having knowledge on LC-MSMS (R4000 and Q-Trap). Development and validation of amino acids and TDM

- Statistical assessment of quality control data in terms of coefficient of variations by applying LJ &West Guard Rules

- Good experience in conducting regression testing with both manual and automated instruments

- Validated NORMAL RANGES for the biochemical parameters based on clinical research-oriented studies

- Isolation of different cytokines and SNP- S by Luminex instrument

- Isolation of DNA, RNA and identify HCV Genotyping by PCR (Real Time and Conventional)

- Isolation of proteins based on molecular weight by SDS PAGE

- Separation of proteins by SERUM PROTEIN ELECTROPHORESIS

- Analysis of different Hemoglobin variants by HPLC

- Knowledge over analyzing, reporting and interpreting results - Proficient over techniques like CLIA, ELISA, PROTEIN ELECTROPHORESIS, IFE, RADIOIMMUNOMETRIC, SPECTROMETRIC, Cell counter, Flow Cytometer, PCR, WESTERNBLOT, ELECTROPHORETIC based methods and its applications

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