QC Analyst – Enzyme Assay

Delhi, India

Role Overview :

The QC Analyst – Enzyme Assay is responsible for performing qualitative and quantitative assays of industrial enzymes to ensure compliance with internal specifications, customer requirements, and applicable regulatory standards. The role involves routine and non-routine testing, method execution and validation, documentation, and continuous improvement of assay accuracy, precision, and efficiency.

Key Responsibilities :

Key Responsibilities :

Enzyme Assay & Testing :

  • Perform routine and non-routine enzyme activity assays (e.g., protease, amylase, cellulase, lipase, xylanase, etc.) as per approved SOPs.
  • Conduct potency, activity, stability, and specificity testing of enzyme products and intermediates.
  • Handle wet chemistry, spectrophotometric, titrimetric, and kinetic assays accurately.
  • Prepare reagents, standards, buffers, and calibration solutions.

Quality Control Operations :

  • Ensure test results comply with product specifications, COAs, and regulatory guidelines.
  • Investigate out-of-specification (OOS), out-of-trend (OOT), and deviation results.
  • Maintain proper sample handling, labelling, storage, and traceability.

Documentation & Compliance :

  • Record and review data in laboratory notebooks, LIMS, and QC reports.
  • Ensure compliance with GMP, ISO, GLP, and internal quality systems.
  • Support internal and external audits by providing documentation and technical explanations.

Method Development & Improvement :

  • Assist in assay optimization, validation, and verification activities.
  • Participate in method transfers from R&D or external partners to QC.
  • Support continuous improvement initiatives to enhance assay robustness and turnaround time.

Equipment & Lab Maintenance :

  • Operate and maintain lab instruments (e.g., UV-Vis spectrophotometers, incubators, pH meters).
  • Perform routine calibration and ensure equipment readiness.
  • Follow laboratory safety, biosafety, and waste disposal procedures.

Qualifications :

Bachelor’s or Master’s degree in Biochemistry, Biotechnology, Microbiology, Chemistry, or a related Field.

Experience :

3-5 years of experience in QC testing of industrial enzymes, biopharmaceuticals, or fermentation-based products (experience level adjustable). Hands-on experience with enzyme assays and activity measurements is mandatory.

Behavioral & Soft Skills :

  • High attention to detail and data accuracy.
  • Strong analytical and problem-solving skills.
  • Good documentation and communication skills.
  • Ability to work independently and in cross-functional teams.
  • Commitment to safety and quality culture.

Preferred / Nice to Have :

  • Experience in industrial fermentation or downstream processing environments.
  • Exposure to method validation (ICH/QbD concepts).
  • Experience with customer audits or regulatory inspections.

Required Technical Skills :

  • Strong understanding of enzyme kinetics and assay principles.
  • Experience with spectrophotometric and biochemical assays.
  • Knowledge of GMP/ISO/GLP laboratory practices.
  • Familiarity with LIMS and data integrity. requirements.
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