Senior Quality Assurance & 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

Qualifications:

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

Required work experience related to position –

• 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

Working Conditions: (describe office, lab environment, include shifts and any travel)

• 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.

Physical Requirements:

• 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