Quality Control Associate - Instrumentation

We are seeking an experienced professional to join our Molecular Biology and Bioassay Laboratories . The ideal candidate will bring strong expertise in laboratory testing techniques and hands-on exposure to processes within the monoclonal antibody DS manufacturing industry .

Educational qualification: A Master’s degree in Chemistry/ Life Sciences, or a related field Minimum work experience : 5 to 8 years of experience in the area laboratory setting, preferably in the biopharmaceutical or related industry Skills & attributes: Technical Skills Perform analysis of drug substance, in-process, stability, cleaning validation, and characterization samples using HPLC, CE-SDS, UV-Vis, TOC, Osmometer, and other analytical instruments as applicable.

Execute analytical testing for batch release, stability studies, method transfer, method qualification, and validation activities within defined timelines while ensuring compliance with approved procedures and cGMP requirements.

Review analytical data, chromatograms, calculations, and test results for completeness, accuracy, and compliance with regulatory requirements.

Perform operation, calibration, routine verification, troubleshooting, and maintenance coordination for HPLC and other laboratory instruments as per approved schedules and procedures.

Participate in analytical method validation, qualification, verification, transfer, comparability, and lifecycle management activities for biopharmaceutical products.

Prepare and review analytical protocols, reports, worksheets, logbooks, laboratory records, and electronic data in compliance with ALCOA+ principles and data integrity requirements.

Investigate laboratory incidents including OOS, OOT, deviations, atypical results, instrument failures, and laboratory errors, and support root cause analysis and CAPA implementation.

Ensure timely updating and maintenance of laboratory trackers, instrument utilization logs, calibration schedules, reagent inventories, reference standard records, and stability databases.

Support regulatory inspections, internal audits, customer audits, and quality management system activities by providing analytical data, records, and technical justifications.

Ensure compliance with cGMP, GDP, Data Integrity, EHS, and laboratory safety requirements while maintaining laboratory housekeeping and inspection readiness at all times.

Collaborate with cross-functional teams including Manufacturing, QA, MSAT, Validation, and Regulatory Affairs to support product lifecycle and site objectives.

Train junior analysts and provide technical guidance on chromatographic techniques, instrument operation, troubleshooting, and GMP documentation practices.

Behavioural Skills • Keen attention to detail in analysis and documentation, ensuring accuracy in all tasks.

•Effective communication and collaboration skills for communicating with the Group Leader, reporting discrepancies, incidents, and providing timely updates.

•Takes initiative in ensuring the proper use and care of instruments, timely destruction of samples, and other assigned responsibilities.

•Demonstrates problem-solving skills in addressing discrepancies, incidents, and ensuring smooth laboratory operations.

•Upholds ethical standards, compliance with SOPs, and follows regulatory requirements in all activities.