Anjali Malhotra has over 20 years of experience in quality assurance and clinical laboratory testing. She currently works as a Quality Assurance Manager at LabCorp Clinical Trials, where she oversees quality objectives and compliance with regulations. Previously, she was a Quality Assurance Coordinator and Cytogenetics Supervisor at Quest Diagnostics, where she established quality management systems and automated processes. Malhotra holds an MBA in Health Care Administration and degrees in Medical Technology and Microbiology and Biochemistry. She maintains certifications in clinical cytogenetics, quality assurance, and Six Sigma.

1. ANJALI MALHOTRA
Cell: 818.209.8893 www.linkedin.com/in/anjalimalhotra1/ anjali_malhotra@outlook.com
SUMMARY
Quality Assurance Manager (ASQ CQA) and ASCP Certified Clinical Cytogenetic Scientist with
expertise in genomic clinical laboratory testing and applications of quality management systems. Used
Six Sigma, Lean and 6S processes resulting in a site culture that embraces ISO Standards. Proficient
with FDA, ISO15189, CLIA, CAP, NYS, OSHA and GLP/GCP regulations and quality management
systems for device, biologics and biotechnology operations. Key Strengths:
• Committed to Quality • Excellent Written and Oral Presentation
• Leadership and Management • Initiative and Follow Through
• Analysis Focused • Problem Resolution
PROFESSIONAL EXPERIENCE
LABCORP, Clinical Trials, Seattle, WA 2012 - Present
Offers custom laboratory services and global capabilities to assist pharmaceutical and drug
development companies with the timely, efficient conduct of clinical trials.
Quality Assurance Manager
Monitored, measured and maintained quality objectives for the site assuring compliance with GLP/GCP
in accordance with FDA Regulations and LabCorp Policies and Standard Operating Procedures.
Conducted internal and external audits for the Regulatory/QA function for the Clinical Trials Facility.
• Prepared audit reports, distributed to the appropriate management staff and ensured corrective
actions effectively addressed the root cause of all findings. Primary contact and liaison for all
external client and regulatory audits and inspections. Also performed external audits of vendors.
• Leads Internal audits which included detailed audits of the facility processes and procedures,
training and competency records, validation Reports, contributing scientist reports/final study
reports and phase audits for GLP studies. Advised audited departments on GLP/GCP standards.
• Acquired ISO15189 reaccreditation for a diagnostic testing facility of LabCorp (2012-2014),
ensuring the delivery of high quality services to patients and clients. Last two ISO 15189 audits
received no deficiencies or recommendations.
• Launched KPI (Key Performance Indicators) Dashboard, focused on customer satisfaction,
exemplary laboratory and clinical practices, and continual improvement. Timely management
reviews of metrics alerted and provided upper management with an accurate perspective of the
laboratory’s performance.
• Maintained and monitored the corporate QMS (Quality Management System), standardized
protocols (Master Control/Agile) and best practices for the site. Includes document control,
regulatory controls, complaint management, identification and control of non-conformities through
the incident management systems, records management, and audits. Tracking and trending
allowed for timely root cause analysis and correction of any potential deviations.
• Prepared summary responses for complaints, audits, CAPAs, proficiency test failures, planned
deviations, non-conformances and service failures.
• Created and monitored database itemizing equipment and instruments, decreasing service
charges by reducing vendor visits and performing service/ maintenances in a timely order.
• Monitored productivity, reduced overtime, kept budged costs under control, adjusted schedules
and cross trained staff. Increased efficiencies with decreasing personnel (2012-2014).

2. ANJALI MALHOTRA 2 | Page
QUEST DIAGNOSTICS, VALENCIA, CA 1997 - 2011
Over $7.5 Billion in revenue offering access to diagnostic testing services for cancer, cardiovascular
disease, infectious disease and neurological disorders.
Quality Assurance Coordinator, Cytogenetics Supervisor
Managed the QA/QC and regulatory requirements for the entire department. Led a staff of 40
technologists and lab associates and monitored daily workflow, TAT metrics, schedules and budget
costs.
• Established and maintained all QMS processes. Investigated all non-conformances, completed
training and competency for all employees ensuring laboratory was “audit ready.”
• Implemented automation in scanning (Metasystems and Bioview) increased efficiencies in TAT and
delivered consistent results.
• Performed cytogenetic wet lab duties, chromosome analysis and fluorescence microscopy (FISH)
on bone marrows, peripheral blood, amniotic fluid, POCs and CVSs meeting TAT on high volume
days.
ADDITIONAL SIGNIFICANT EXPERIENCE
UCLA, Dept. of Immunology, Research Assistant, Performed RNA purification and studies on persistent
infections.
EDUCATION
MBA, Health Care Administration, NYIT, NY
BA, Medical Technology, CSUN, Northridge, CA
BSc, Microbiology and Biochemistry, St. Xaviers, India
PROFESSIONAL DEVELOPMENT
Regulatory Affairs Certification (Pending)
ASQ CQA Certification
State of CA Dept. of Public Health, Clinical Cytogeneticist Scientist
ASCP Certified Clinical Lab Specialist in Cytogenetics
Six Sigma Green Belt
ASCP-CAPA-Root Cause Analysis Course
Covance-Drug and Development Course
PROFESSIONAL AFFILIATIONS
ASQ, American Society for Quality
Delta Mu Delta, A US National Honor Society in Business Administration