Job Summary:

The QC Analyst is responsible for performing analytical testing of raw materials, in-process samples, and finished pharmaceutical products to ensure compliance with USFDA regulations, cGMP standards, and internal specifications. This role is critical in maintaining product quality, safety, and efficacy.

Key Responsibilities:

Analytical Testing:

Conduct chemical, physical, and microbiological tests using techniques such as HPLC, GC, UV-Vis, FTIR, titration, and dissolution. Perform stability studies and method validation as per regulatory guidelines.

Documentation & Compliance:

Maintain accurate and complete records of all testing activities in compliance with GDP. Document and investigate any Out-of-Specification (OOS) results. Ensure adherence to cGMP, GLP, and USFDA regulations.

Equipment Handling:

Calibrate, maintain, and troubleshoot laboratory instruments. Ensure proper usage and upkeep of analytical equipment.

Cross-Functional Collaboration:

Coordinate with Production, QA, and R&D teams to resolve quality issues. Participate in internal and external audits.

Continuous Improvement:

Assist in developing and validating new analytical methods. Recommend improvements to testing procedures and quality systems. Qualifications: Bachelor’s or Master’s degree in Chemistry, Pharmaceutical Sciences, or related field. 2–5 years of experience in a pharmaceutical QC laboratory, preferably in a USFDA-approved facility. Hands-on experience with analytical instruments and techniques. Knowledge of regulatory guidelines (USFDA, ICH, WHO). Strong attention to detail and analytical skills. Preferred Certifications: Certified Quality Analyst (CQA) Training in cGMP, GLP, and data integrity Soft Skills: Excellent communication and documentation skills Ability to work independently and in a team Problem-solving and critical thinking abilities