Quality Assurance Specialist
Resume:
BIJAL R PATEL
**************@*****.***
Anaheim, CA
ABOUT Meticulous and accomplished GCP Quality Assurance Specialist with 15 years of experience in clinical research and quality assurance. Demonstrated success in ensuring compliance with Good Clinical Practice (GCP) and global regulatory standards through strategic audit oversight, process optimization, and staff training. Proven ability to develop and implement QA frameworks, proactively identify and mitigate compliance risks, and lead corrective and preventive action (CAPA) initiatives that elevate trial integrity. Highly skilled in cross-functional collaboration and in translating complex compliance requirements into practical, actionable solutions. Recognized for critical thinking, meticulous diligence, and an unwavering commitment to advancing high-quality, ethically sound clinical trials.
EXPERIENCE CenExel Anaheim Clinical Trials
2023-Pres
Quality Assurance Specialist
Responsible for developing and implementing comprehensive GCP quality management systems, including policies, standard operating procedures (SOPs) and Working Practices (WPs), enhancing compliance and operational efficiency.
Responsible for Ensuring GCP compliance for multiple ongoing clinical (Phase I-IV), BA/BE trials through rigorous oversight and regular assessments.
Identifying compliance risks and formulating and implementing effective risk mitigation strategies, reducing potential for non- compliance.
Responsible for monitoring, tracking, and analyzing GCP non- conformances, deviations, and CAPAs, providing regular updates and recommendations to management.
Managing internal and external GCP audit activities, including clinical vendor Laboratory qualifications, internal site audits, and follow-up on corrective actions to ensure adherence to compliance standards.
Lead in informed consent checks.
Responsible for hosting and preparing for Regulatory Inspections and Sponsor Audits.
Host and Manage sponsor and regulatory audits, serving as primary point of contact; coordinate all audit activities and deliver timely, comprehensive responses to observations, ensuring continuous compliance with GxP and regulatory standards.
BIJAL R PATEL
**************@*****.***
Anaheim, CA
CenExel Anaheim Clinical Trials
2022-2023
Compliance Coordinator
Assisted in Quality Assurance and Regulatory department in preparation of external audits (FDA, PMDA, EU, Sponsor, CRO) regarding training and delegation logs.
Lead in ensuring onboarding documents and appropriate licenses/certification/training are obtained, documented and are up to date.
Improved the onboarding process relating to training documents.
Assisted with identification, development, and implementation of processes based on feedback from the Regulatory, Quality Assurance, Operations, and self-discovery regarding delegation of authority logs and trainings.
Conduct regular audits on completeness and accuracy of delegation log assignments and trainings.
Provided training and education to clinical staff on site SOPs, GCP, and federal regulations as appropriate.
Tracked metrics via Excel as applicable, reporting data to the COO on a regular basis.
CenExel Anaheim Clinical Trials
2019-2020
Quality Assurance Associate
Assisted in the development and maintenance of GCP quality management systems and related documentation.
Conducted periodic reviews of clinical trial documentation and processes to ensure compliance with GCP guidelines.
Participated in GCP audits and inspections, including preparing necessary documentation and addressing audit findings.
Assisted in the management of non-conformance issues, deviations, and CAPAs, ensuring timely resolution and communication to stakeholders.
Sunpharmaceutical Industries Ltd. Guj, India
2007-2019
Quality Compliance Manager
Conducted retrospective reviews of trial/study-related data, including Informed Consent Forms (ICF), Case Report Forms
(CRF), and Trial Master Files (TMF) to ensure compliance with GCP and in-house SOPs. Submitted data for QA review and addressed queries raised.
Monitored key activities during Bioequivalence/Bioavailability studies, including dosing and sample separation, to ensure adherence to study protocols.
BIJAL R PATEL
**************@*****.***
Anaheim, CA
Prepared and reviewed Standard Operating Procedures
(SOPs), work instructions, and manuals to maintain high standards of quality and compliance.
Issued study and non-study related documents, ensuring proper documentation and traceability.
Coordinated departmental training programs, imparting knowledge and skills to subordinates to enhance compliance and efficiency.
Identified, handled, and reviewed deviations and incidents, initiating and managing CAPA processes in accordance with SOPs.
Collaborated with cross-functional teams to address compliance issues and drive continuous improvement. Toprani Advanced Laboratory System, Guj, India
2002-2007
Microbiologist
Conducted routine bacterial cultures for a variety of samples, including urine, pus, cerebrospinal fluid (CSF), and other body fluids.
Cultivated and identified Mycobacterium using conventional methods and PCR Gen probe techniques.
Operated and maintained advanced laboratory instruments, including BacT/Alert, Gen probe, and BACTEC systems.
Specialized in acid-fast bacilli (AFB) and Gram-stained microscopy, demonstrating proficiency in diagnostic techniques.
Successfully managed and completed the NABL (National Accreditation Board for Testing and Calibration Laboratories) audit.
ACADEMIC
CREDENTIALS
Master of Science (Medical Microbiology)
2002
Bachelor of Science (Zoology)
1998
(Maharaja Sayajirao University, Gujarat, India)
LANGUAGES English
Hindi
Gujarati
BIJAL R PATEL
**************@*****.***
Anaheim, CA
SKILLS Expertise in GCP quality management systems
Strong knowledge of clinical trial processes and regulatory requirements
Proficiency in conducting audits and managing compliance activities
Ability to develop and implement effective risk mitigation strategies
Excellent communication and documentation skills
Proficient in quality control and assurance practices COMPUTER
PROFICIENCY
Basic
Microsoft Office
Microsoft Excel
Power Point
Medical Software
RealTime (e-Reg system)
Florence (e-Reg system)
ClinSpark (e-Source system)
CLIS (Clinical Laboratory Integration system)
EDMS( Electronic Data management system)
REFERENCES Will be provided upon request
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