Resume of Laboratory Analyst in Text Format
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LABORATORY ANALYST - leveraging 8+ years of experience
Meticulous laboratory specialist with a comprehensive experience in the Pharma sector. Performs GMP testing of raw materials, in-process and finished products, stability samples, and non-routine sample analyses per established procedures and methodology. Monitors and evaluates systems, equipment, records, and trends data. Reviews and revises documentation (i.e. SOPs). Works under limited supervision following established procedures.
- Acquainted with Quality Compliance cGMP, ICHIFD, AIUSP, and EP guidelines.
- Experience in the development of Biopharmaceutical, Biologics, and Large Molecule products.
- Ability to work with non-hazardous and hazardous chemicals, toxic metals, cryogenic gases, and radioactive materials.
- Demonstrated research experience in clinical research and regulatory affairs in a pharmaceutical company.
- Quality Compliance
- GLP/ GLP
- Regulatory review
- Clinical Procedures
- Analytical Chemistry
- Safety Update Reports
- Standard Operating Procedure (SOP)
- USP test methods
Bayer, New Delhi Jan. 2018 – Present
Laboratory Analyst IV
- Provide timely, accurate preparation, evaluation, and recording of seed analyses.
- Complete the testing processes ensuring process control, accurate data management, timely escalation of problem-solving, and error correction under the direction of Lab Operations Managers and/or Lab Coordinators.
- Troubleshoot testing processes and ensure appropriate error resolutions.
- Aid in training new Lab Analysts and participate in the review and creation of training materials.
- Learn and apply scientific methods and non-routine techniques for analysis as directed by protocols and work instructions to deliver quality results – including preparation of reagents, media, controls and sample preparations.
- Lead in Management of Change process and updates of testing protocols and work instructions.
- Work independently within a team environment to ensure all testing is conducted in compliance with Bayer ESH policies, Laboratory QMS and protocols, and Regulatory agency requirements.
- Provide oversight and task-related feedback to contingent labor.
- Maintain reagents and consumables to required inventory levels.
- Lead special projects and teams.
- Provide technical process support (e.g., equipment issues, method improvement).
- Participate in a continuous improvement program focused on enhancing current processes and performing root cause analyses and troubleshooting issues.
- Participate in Bayer’s ESH safety program and cross-site projects and initiatives.
Sun Pharmaceutical Industries Ltd., New Delhi July. 2016 – Nov. 2018
Laboratory Analyst III
- Performed release, stability, validation, analytical quality-control tests, and assays on raw materials, in-processing and final products following GLPs.
- Performed quality control tests and assays including USP test methods and EP test methods Conducted, documented, and followed up on assay issues, failures, and complaint investigations using Trackwise.
- Calibrated, monitored, maintained, and evaluated systems and equipment like water systems, environmental chambers, and analytical instruments/equipment.
- Maintained data in manual or computer-based logs following GDPs Developed, authored, and executed instrument IQ/OQ and PQ protocols.
- Maintained major laboratory programs (i.e. calibration program, reference standard program).
- Served as liaison to service, calibration, and technical representatives.
- Sent samples to contract laboratories and collect test data.
- Washed glassware, and prepared reagents, solutions, and equipment for chemical tests and assays.
- Maintained laboratory in cGMP compliance and conduct internal lab inspections.
- Recorded and reviewed GMP data, and monitored, and evaluated QC systems and equipment.
- Recommended improvements to procedures, and revise GMP documentation as required.
- Served as a leader within the QC group and a knowledge resource within the company.
- Provided mentoring and training to junior analysts on laboratory tests, skills, and lab processes. Performed monthly equipment/instrument maintenance and cleaning.
Cipla Ltd., New Delhi July. 2014 – Jun. 2016
- Managed samples in the laboratory information management system (LIMS).
- Ensured quick and efficient specimen processing
- Developed a firm understanding of internal lab processes and databases.
- Communicated directly with various members of departments to provide clarity on specimen status, delays, and expected completion dates.
- Responded to inquiries by email and in person quickly and professionally.
- Tracked progress on laboratory projects.
- Participated in monitoring audits of sample status and prevention of delays.
- Monitored high-priority orders to ensure customer satisfaction and retention.
Cipla Ltd., New Delhi July. 2013 – Jun. 2014
Laboratory Analyst - Intern
- Performed basic functions like weighing samples, washing glassware, and preparing samples using standard techniques.
- Recorded and reported data and any unusual test occurrences to the supervisor Performed routine instrument maintenance and conducted all activities in a safe and efficient manner.
- Applied GMP/GLP in all areas of responsibility, as appropriate, Worked under close supervision using routine and standard methods.
- Took responsibility for general housekeeping in the group’s work area.
- Learned to use the Laboratory Information Management System to access sample backlogs, schedule work, record essential data, and information, calculate results and report client data.
- Education – M. Sc. Chemistry from Pune University, Pune | 2014 B.Sc. Chemistry from University of Delhi, Delhi | 2012
Languages Known: English, German & Hindi
~References and other documents available upon request ~
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