Quality Assurance Project Manager

Dharati Patel, MLS (ASCP) CM

Gainesville, FL 908-***-**** ***********@*****.***

SUMMARY

Dynamic and results-driven leader with extensive experience in clinical laboratory operations, quality assurance, and management. Proven expertise in developing and maintaining high-quality standards, implementing new processes, and driving change initiatives. Passionate advocate for safety and continuous quality improvement, with a track record of elevating laboratories to the highest levels of regulatory compliance. Highly adaptable, quick to learn new concepts, and eager to embrace challenges. Demonstrated success in managing diverse projects across various industries, consistently delivering on time and within budget. Skilled in team leadership, strategic planning, and stakeholder management, with a proven ability to thrive in dynamic and demanding environments to meet critical deadlines.

PROFESSIONAL EXPERIENCE

Abbott Point of care, Princeton NJ

Project Manager, Global Scientific Affairs June 2022 - Present

Supported the overall coordination of investigator sponsored studies (ISS) and collaborative research studies (CRS) from initiation of study discussions, concept/proposal submission, review & collaboration, start-up to study close-out, including agreement execution, study material shipment, site training, gathering and communicating periodic study updates, timely execution of the study, invoice submissions, and other activities.

Managed end-to-end project activities, including scope, planning, execution, budget management, risk management, timelines, deliverables, and progress tracking.

Communicated project goals, milestones, and updates to senior management and functional areas. Proactively escalated issues to the Program Lead and stakeholders, implementing resolutions effectively.

Identified areas for improvement, developed and implemented best practice to improve efficiencies.

Oversaw critical study start-up activities such as document management, shipment planning, supply forecasting, milestone discussions, and agreement finalizations.

Served as the primary contact with customers and investigator. Acts as an additional resource for technical questions, inquiries and troubleshooting.

Facilitated contracting for all Scientific Affairs needs, including research studies, CDAs for KOL engagement, and advisory board-related contracting. Guided contract drafting, negotiation, administration, and renewal.

Experienced in working with CROs (such as Clinical Trial Coordinating Center) and government-issued grants (CRADA, NIH, DoD).

Managed study proposal submission through the IdeaPoint portal, overseeing receipt of investigator-initiated concepts/proposals and early access requests, and conducting initial reviews.

Created study training content and protocol/manual of procedures development. Provides i-STAT system training to ISS study site staff, following the approved study protocol and agreement.

Ensured continuous audit readiness of studies/projects.

Senior Specialist Quality Assurance CAPA Feb-2023- April 2024

Directed quality-related activities to ensure the delivery of consistently high-quality documents, services, products, and processes. Played a pivotal role in maintaining, improving, and ensuring compliance with critical elements of the quality system, including Nonconformance report (NCR), Corrective and preventive action (CAPA), Document Control, Audit Support, Training, and Validation. Focused on unwavering on delivering excellence and compliance, driving significant improvements in quality standards and operational efficiency.

Successfully initiated, investigated, and implemented corrective actions, leading business partners to efficiently generate and finalize NCR, CAPAs tough Trackwise system. This strategic approach led to a remarkable improvement in CAPA metrics and a reduction in resolution time.

Utilized Root Cause Analysis (RCA) methodologies like 5 Whys, Fishbone diagram, and FMEA to solve complex problems.

Oversee the end-to-end deviation process, from identification to closure, ensuring that deviations are closed and corrective actions are completed within defined deadlines

Prepared and communicated quality metrics for management review and process improvements.

Led inspection readiness, ensuring preparedness for regulatory inspections. Managed audit support, providing comprehensive assistance for internal and external audits. Supported GMP inspections, effectively managing follow-up actions and CAPA implementation.

Supervisor, Technical, Product Development June 2022-Feb 2023

Research and Development Laboratory Implementation

Executed set up of a new i-STAT product laboratory testing capability at Princeton location. Implemented and maintained laboratory quality and compliance standards required for data to be used in the regulatory submission. Lead biological testing activities, planed, and executed characterization and verification studies for various i-STAT product development program and product enhancement projects. Act as liaison for APOC site collaboration, coordination, and communication to ensure alignment in planning, execution, data integrity and data analysis.

Managed project planning, task management, risk mitigation, and coordination of team activities for new R&D lab initiatives.

Provided consultation throughout the project life cycle, including planning, designing, documenting, integrating, communication, reporting, change management, and incident management.

Developed comprehensive deliverables such as validation plans, requirements specifications, qualification documents, traceability matrices, summary reports, change controls, and failure mode & effect analysis.

Supported site preparation, Equipment Installation/Qualification/Validation, Supplier/Vendor selection, personnel management, safety, compliance, calibration, maintenance, material tracking, inventory, and facility improvements.

Hired, coached, trained, and developed staff and third-party partners. Managed personnel development and succession planning, ensuring timely completion of people management and administrative tasks.

Directed blood collection program activities for clinical studies, ensuring timely and budget-compliant deliverables. Crafted critical clinical documents, including protocols and Informed Consent Forms (ICFs).

Centers Lab, Cedar Knoll NJ December 2019 - May 2022

Director of Quality

Demonstrated expertise in clinical assay design, validation, and implementation. Expert in spearheading large-scale laboratory implementation projects, with deep proficiency in laboratory automation, laboratory information systems, and middleware solutions. As Quality Director, led the first laboratory in the Northeast to integrate the cutting-edge Siemens robotic track system, revolutionizing high-throughput sample testing across Siemens Atellica analyzers, Sysmex hematology platform, Immulite, and Biorad Bioplex. Extensive experience in clinical molecular assay design, validation, and implementation such as Thermo Fisher 7500DX, Quant Studio 7 Flex, Hologic Panther, and Quidel Solana.

Provided comprehensive technical oversight across all laboratory departments, ensuring rigorous quality control, proactive equipment maintenance, and full compliance with safety protocols.

Led the laboratory’s Quality Program, ensuring consistent delivery of accurate and reliable test results in alignment with state, federal, and accreditation standards. Served as the primary liaison to external regulatory and accrediting bodies

Ensured full compliance of laboratory operations and personnel with federal and state regulations, including CLIA, CAP, OSHA, NJDOH, and NYSDOH standards.

Established and continuously monitored policies and procedures across all testing phases (Pre-Analytical, Analytical, Post-Analytical), identifying gaps and implementing remedial training or continuing education to maintain high standards of practice.

Performed internal audits, developed and implemented corrective action plans, led root cause investigations, and documented remedial actions to ensure compliance with regulatory standards and continuous quality improvement.

Chaired monthly quality assurance meetings, developed and tracked key performance indicators (KPIs), and implemented process improvements that enhanced overall quality metrics and operational efficiency.

Ensured accuracy of quality records, analyzed data for critical trends and failures, and verified comprehensive QC/QA documentation.

Led communicable disease reporting initiatives and implemented electronic laboratory reporting (ELR) systems to streamline data exchange between clinical laboratories and public health departments, enhancing real-time surveillance and response capabilities.

Established and maintained robust Document Management and Change Control systems to ensure traceability, compliance, and operational consistency.

Proactively identified opportunities for laboratory process improvements, driving efficiency, accuracy, and regulatory alignment.

Promoted a positive and professional work environment by serving as a role model, coach, mentor, and resource for staff and peers.

Bio Reference Laboratories, Elmwood Park NJ April 2018- December 2019

Clinical Lab Quality System Technical Coordinator

Medical Technologist November 2014 –April 2018

Generalist, Chemistry, Hematology, Blood bank

EDUCATION

Bachelor of Science in Clinical Laboratory Science – Combine, Joint Degree October 2014

Rutgers University – School of Health-Related Profession, Newark NJ

New Jersey City University, Jersey City, NJ

Bachelor of Science in Microbiology June 2009

Jethabhai and Jhaverbhai (J&J) College of Science, Gujarat, India

CERTIFICATIONS

American Society for Clinical Pathology (ASCP)

Medical Laboratory Scientist- MLS (ASCP) CM

The College of American Pathologists (CAP)

Inspection Team Member – Perform Inspection/Audit for multiple areas of clinical laboratory.

KNOWLEDGE, SKILLS, AND ABILITIES

Cardiology- hs-TnI, Neurology- TBI, Hematology, Special Coagulation, Urinalysis, Immunology, Serology, Immunohematology (Blood Bank), Clinical Chemistry, Microbiology, Toxicology, Cytology, Molecular

GMP regulations and industry expectations, GCP,GLP regulations

FDA 21 CFR 820 Medical Devise Regulation, Clinical Research/ICH Regulation

Quality Systems Management and Operations Management, Document Control Management

Non-Conformance, CAPA, Root Cause Analysis, Risk management, GAP Analysis, Process Improvement

External & Internal Audit/Inspection Management

CLIA, CAP, NJ, NYS, multiple states, federal clinical laboratory regulations

Laboratory Licensure - Application/Submission

Method/Assay/Equipment/Instrument - Qualification/Implementation/Validation

Laboratory information systems – Implementation/validation

Microsoft Office, SharePoint, Smartsheet, Unity Real Time, QC net, EP Evaluator, Master Control, Media Lab, TrackWise

Strong analytical and critical thinking and risk development/management

Team leadership and development

Strong communication skills, cross-functional collaboration skills, and a cross-cultural awareness.

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