Quality control

Job Summary:

We are seeking a highly motivated and detail-oriented Quality Control Analyst to join our biotechnology team. The ideal candidate will be responsible for performing laboratory testing to ensure products meet established specifications and regulatory requirements. This position plays a critical role in maintaining the integrity and safety of our biotechnological products.

Key Responsibilities:

• Perform routine and non-routine analytical testing (e.g., ELISA, PCR, HPLC, SDS-PAGE, spectrophotometry) on raw materials, in-process samples, and finished products.
• Ensure all laboratory activities are performed in compliance with cGMP, GLP, and company SOPs.
• Conduct environmental monitoring of cleanroom and production areas.
• Maintain accurate and detailed laboratory records, including test results and observations.
• Perform calibration and maintenance of laboratory instruments.
• Investigate and document deviations, OOS (Out of Specification), and OOT (Out of Trend) results.
• Support method validation, equipment qualification, and technology transfer processes.
• Participate in internal and external audits as required.
• Collaborate with cross-functional teams including QA, R&D, and Manufacturing.

Qualifications:

• Bachelor’s or Master’s degree in Biotechnology, Microbiology, Biochemistry, or related field.
• 1–3 years of experience in a GMP-regulated quality control laboratory (biotech or pharma preferred).
• Proficient in analytical techniques such as ELISA, qPCR, HPLC, and microbiological assays.
• Knowledge of regulatory standards including FDA, EMA, and ICH guidelines.
• Strong organizational and communication skills.
• Ability to work independently and in a team-oriented environment.

Preferred Skills:

• Experience with LIMS or other electronic data management systems.
• Familiarity with biologics or cell & gene therapy products.
• Experience in stability testing and trending of quality data.

Working Conditions:

• Laboratory and cleanroom environments.
• May involve occasional weekend or shift work depending on project needs.

Job Type: Full-time

Pay: ₹200,000.00 - ₹300,000.00 per year

Education:

• Bachelor's (Required)

Location:

• Pondy, Puducherry (Required)

Work Location: In person