Senior Quality Assurance And Lab Technologist

Main Responsibilities

• Provide advice and support to the Laboratory Director, department managers and testing personnel on quality issues.
• Will implement and document routine deviations, incidents, Risk management, Vendor & referral lab evaluations, Non conformances- external and internal audit based
• Understand the existing Document Control System (PolicyTech) and train seniors of each department to take ownership of SOPs.
• Shall update Trainings and Policies as per current requirements and conduct yearly training as appropriate.
• Assist to ensure completion of all SOPs and all reports, review/ document validations
• Apply and face external Audits- CAP, ISO and NABL-, document, close and implement practices to clear all non conformances recorded.
• Conduct yearly internal audit along with department managers and senior techs
• Lead and implement various product and process improvement methodologies (e.g., Six Sigma)
• Lead risk assessments and management plan for all departments and laboratory activities
• Will coordinate with external engineers, department managers and team to carry out calibration of all equipment in time and document the same.
• Work with commercial team to plan external calibration engineers visits and continued AMC contracts
• Ensure employee vaccinations and routine eye testing is done as required on a timely and periodic basis.
• Will collaborate with external lab and commercial team to conduct and document sterility checks of specific instruments on monthly basis.
• Shall ensure strict adherence, and no deviation from essential quality norms specially related to PCPNDT, and DPDPA (data privacy laws) amongst others.
• Shall work with global QC manager /team and support teams such as legal/ regulatory to understand and implement updated good laboratory practices and current regulatory / legal requirements.
• Shall become familiar with the operation of laboratory instruments and applicable computer softwares.
• Shall perform wetlab/ observational activities across laboratories for timely completion of process
• Other duties as assigned
• Seeking support from Quality Manager for all laboratory specific documents, risk management approaches which have been previously established
• Ensure enrollment to all PT: EQAS/ ILC each year
  
  
  

• M.Sc., / B.Sc., Biochemistry / Genetics / Microbiology / Medical Laboratory Technology (MLT) or related disciplines
  
  
  

• Minimum 6 years of experience in quality management or related clinical laboratory activities.
• Should have prepared and faced NABL Assessors / CAP Inspectors.
• Must be able to assess the need for, handle and implement Quality Improvement initiatives Independently.
• Prepare Quality Metrics, Report Management results of Improvements, Conduct Internal Audits, Face External Audits, Prepare Reporting, Documentation, SOP preparation, Change Control, etc
• Experience with Quality Assurance, statistical Quality Control, and laboratory regulations/accreditation requirements required.
• Previous experience of working in quality in clinical molecular biology or biochemical genetics testing labs as a Lab Technologist.
• Comfortable working in a fast-paced environment
  
  
  

• Clinical and research lab environment; exposure to blood borne pathogens; must wear personal protective equipment including lab coat, gloves and completely closed footwear while in the Laboratory.
• Travel to other sites may be required.
  
  
  

• While performing the duties of this job, the employee is regularly required to sit, stand, use a keyboard, type, and occasionally stand and move to other parts of the lab
• Reach above/below the shoulder, bend at the knees and waist.
• Able to lift boxes up to 25 pounds