Puja Khanal

Proactive Quality Assurance Analyst with excellent oral and written communication skills. Extensive knowledge of computer applications, quality control, and microbiology. Strong background in quality testing, with experience identifying and resolving quality issues, nonconformances, issue evaluations, root cause analysis, and CAPA.

Quality Assurance Analyst at Zimmer Biomet (2023-01 – Present)

• Lead QA technician for drug product testing and release; Gel-Clot and Kinetic Endotoxin testing, Assay ID (Sodium, Dextrose, Chloride, Citrate strong acid and base), pH, sterility, and particulates.
• Perform weekly viable and non-viable environmental monitoring in ISO 7 and ISO 8 cleanroom suites using aseptic techniques and compressed air sampling.
• Performed testing on medical device kits using FTIR, the Texture Analyzer TA-XT Plus for relative paste hardness, and injectability testing to ensure products met acceptable quality standards.
• Compiled and reviewed documentation for modules submitted to auditors.
• Follow cGMP, Good Documentation Practices (GDP), current 21 CFR regulations, and ISO standards.
• Hands-on experience performing growth promotion testing on various media plates and streaking plates to identify microorganisms.
• Trained new hires and production operators in aseptic handling and cleanroom techniques.
• Maintained accurate data and provided feedback while peer-reviewing documentation for the Quality Control and Production departments.
• Participated in document redlining by reviewing and recommending revisions to SOPs related to quality control procedures and material specifications.
• Created trend reports to identify potential issues and support continuous improvement initiatives.
• Developed and executed test plans, identifying defects and ensuring adherence to specifications.

QC Technician at Chemi drug Industries (2014-04 – 2015-12)

• Conducted environmental monitoring and sample collection while ensuring the accuracy and compliance of laboratory reports.
• Performed bioburden testing on purified water and compressed air to support laboratory quality assurance.
• Adhered to GLP and GDP practices, managing inventory control, ordering laboratory supplies, and disposing of chemical and biohazard waste responsibly.
• Conducted quality control inspections to ensure compliance with industry standards and regulatory requirements.
• Developed and implemented testing procedures for raw materials and finished products, enhancing accuracy in results.

Master of Science in Microbiology and Cell Science – University of Florida (2027-05)

Bachelor of Science in Biology – University Massachusetts Boston (2022-05)

Associate of Science in Biology – Quincy College (2020-05)