QC Data Analyst

Position Summary

Genista Biosciences is seeking a meticulous QC Data Analyst to join our team in Ahmedabad, India. This role is crucial for ensuring the quality and compliance of food samples tested in our laboratory. You will be responsible for collecting, analyzing, and interpreting data to uphold internal quality standards and meet external regulatory requirements. As a vital link between Quality Control and Regulatory Affairs, you will verify data integrity, monitor product compliance with national and international food regulations, and contribute to the preparation of essential technical and regulatory documentation. The ideal candidate will demonstrate strong analytical abilities, exceptional attention to detail, and a solid understanding of food safety standards and regulatory frameworks.

Key Responsibilities

• Data Review & Verification: Review test results, perform data validation, and generate Certificates of Analysis (COAs) in accordance with company procedures and applicable regulations.
• Data Integrity & Analysis: Ensure the accuracy and consistency of data entered into Laboratory Information Management Systems (LIMS); perform calculations and statistical analyses to identify trends and verify product compliance.
• Non-Conformance Investigation: Investigate out-of-specification (OOS) and non-compliant results, identify root causes, and recommend corrective and preventive actions (CAPA).
• Regulatory Affairs Support:
  • Ensure all analytical data and reports comply with relevant food regulations (e.g., FSSAI, Codex, EU, FDA).
  • Assist in the preparation and maintenance of regulatory documentation, product dossiers, and compliance reports.
  • Coordinate with regulatory authorities or certification bodies during inspections, audits, and product submissions.
• Cross-functional Collaboration: Communicate findings and collaborate with production and regulatory teams to address quality or compliance concerns.
• Reporting: Prepare and present detailed reports summarizing analytical findings, trends, and deviations to key stakeholders.
• Continuous Improvement: Participate in quality system reviews and contribute to the enhancement of data management and regulatory compliance processes.

Required Skills

• Strong analytical and statistical data interpretation skills.
• Thorough understanding of food safety and quality regulations (FDA, FSSAI, ISO 17025, etc.).
• Excellent attention to detail and documentation accuracy.
• Proficiency with LIMS and data management systems.
• Effective communication and cross-department collaboration skills.
• Knowledge of regulatory submission processes and documentation standards.

Education & Experience

• Master's degree or PhD in Food Science, Chemistry, Microbiology, or a related discipline.
• 2-5 years of prior experience in food testing laboratories, regulatory affairs, or quality assurance is preferred.