Quality Assurance & Validation Specialist

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Khusboo P.

Phone: 443-***-**** Email: **********@*****.***

CAREER OBJECTIVE

Motivated biotechnology professional with hands-on experience in laboratory techniques, quality assurance, validation and calibration within pharmaceutical and biotechnology environments. Skilled in quality assurance, inspection, cGMP compliance, data entry, laboratory management system, scientific documentation and interpersonal skills.

PROFESSIONAL EXPERIENCE

VaLogic LLC, Frederick, MD, USA Sep 2021- Apr 2024 Validation Technician II

• Generate and execute validation protocols including IQ, OQ, PQ and DQ for Controlled- Temperature Units (CTUs), process equipments and analytical equipments

• Author final reports summarizing the execution of validation protocols and support documents

• SOP preparation for equipment and laboratory instrumentation

• Understanding of URS, FAT, SAT

• Initiate and organize validation activities with Quality Assurance, Engineering and System Owners

• Perform as a team lead at client sites during on-going projects

• Proficient in use of validation test equipments from Kaye AVS, TMI and Ellabs

• Assisted Calibration team and Maintenance department in data collection, processing and storage

• Regularly update preventive maintenance log and managing inventory

• Utilized environmental monitoring systems including MAS-100, Lighthouse system, Met One

• Perform Environmental monitoring of cleanroom and laboratory areas to ensure compliance with GMP/GLP standards

• Author exceptions or deviations arising from validation work including investigation, root cause analysis (RCA), corrective and/or preventive actions (CAPA)

• Apply established Good Document Practice (GDP) for Creating, Correcting, and Presenting data in compliance with current Good Manufacturing Practices (cGMP)

• Responsible for creating, organizing, executing and completing projects

• Setting deadlines, managing relevant employees, communicating with company and client management teams about the state of the project, ensuring project stays on track and budget and making changes, if necessary, to meet new requirements

• Working closely with Calibration, Validation, Laboratory services and Maintenance departments and assisting in CQV activities

2

Kent State University, OH, USA Jan 2018- May 2018

Student Worker

Green Laboratories, Surat, India Dec 2011- Dec 2017 Assistant Laboratory Technician

• Collecting patients’ medical history and maintaining records while handling sensitive information

• Preparing microscopic slides to be examined by the pathologist while practicing GLP

• Operating and handling sensitive scientific instruments such as Ultracentrifuge, Microtome, Microscope, Autoclave

• Sterilizing laboratory equipment and maintaining hygienic and safe working environment

• Maintaining inventory

• Developing and leading pilot projects under closed supervision

• Organizing remote health camps to spread awareness amongst underprivileged groups of people

• Managing and deploying team of healthcare workers and ensuring to meet the standard of the organization

EDUCATION

M.S Biotechnology, Harrisburg University of Science & Technology, PA, USA Current

(Relevant Coursework: Pharmacology, Biostatistics, Medical Biotechnology, Biomaterials, Bioanalytical Methods, Ethics)

Master of Project Management Science with the concentration in Biotechnology, Harrisburg University of Science & Technology, PA, USA 2022 B.S. Biotechnology

Sardar Patel University, Gujarat, India 2009

TRAINING

• Good Documentation Practices (GDP)

• Current Good Manufacturing Practices (cGMP) and Current Good Laboratory Practices (cGLP)

• Validation Requirements for (Good Practice) GxP Systems

• “HPLC, HPTLC & GC/GC-MS” instruments at the Sophisticated Instrumentation Centre for Applied Research & Testing (SICART)

• Proficient in MS-Office and Adobe

• Proficient in Project Management Software

• Proficient in Laboratory management system

• Conducting scientific experiments under highly controlled environments

• Experience in working aseptic conditions and handling hazardous chemicals

• Cleanroom gowning

3

CERTIFICATION

• Promoting Quality of Medicines Plus, USP, 2023

VOLUNTEER

• Counsel patients at regional health camps organized by local health departments, 2014

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