QC Executive

Key Responsibilities

• Perform testing of raw materials in-process samples drug substance drug product stability samples and finished products.
• Perform analytical techniques including HPLC ELISA UV-Vis Spectrophotometer SDS-PAGE Western Blot CE-SDS iCIEF Protein Concentration Endotoxin (BET) pH Osmolality TOC and other biologics assays as applicable.
• Execute routine laboratory activities following approved SOPs STPs and specifications.
• Maintain laboratory notebooks logbooks worksheets and electronic records in compliance with ALCOA and Data Integrity requirements.
• Review analytical data and report results within defined timelines.
• Support OOS OOT deviation CAPA and laboratory investigation activities.
• Perform calibration qualification and routine maintenance of analytical instruments.
• Support method verification method validation method transfer and stability studies.
• Ensure compliance with cGMP GLP GDP and 21 CFR Part 11 requirements.
• Perform sample management reference standard management and reagent preparation.
• Coordinate with Manufacturing QA QC Microbiology and Stability teams for timely sample testing and batch release.
• Participate in internal audits regulatory inspections and customer audits.
• Maintain laboratory housekeeping and follow EHS guidelines.

Required Skills:

Raw Material Testing In-Process Sample Testing Drug Substance Testing Drug Product Testing Stability Sample Testing Finished Product Testing HPLC ELISA UV-Vis Spectrophotometer SDS-PAGE Western Blot CE-SDS iCIEF Protein Concentration Endotoxin (BET) pH Osmolality TOC Biologics Assays SOP Compliance STP Compliance ALCOA Data Integrity Analytical Data Review OOS Investigation OOT Investigation Deviation Management CAPA Laboratory Investigations Instrument Calibration Instrument Qualification Instrument Maintenance Method Verification Method Validation Method Transfer Stability Studies cGMP GLP GDP 21 CFR Part 11 Sample Management Reference Standard Management Reagent Preparation Cross-functional Coordination Batch Release Internal Audits Regulatory Inspections Customer Audits Laboratory Housekeeping EHS Guidelines