LIMS
Rahul Ray
Quality Assurance Professional
Feasterville,PA
Summary
Accomplished Quality Assurance professional with over 10 years of experience managing quality systems and ensuring regulatory compliance with FDA, GMP, GLP, and ISO standards (ISO 9001, ISO 13485, ISO/IEC 17025). Expert in conducting internal and external audits, CAPA implementation, Change Control and root cause analysis. Proven track record in leading teams to achieve continuous improvement through Six Sigma methodologies, enhancing operational efficiency. Adept at managing QMS and fostering a culture of compliance and safety. Strong leadership, problem-solving, and interpersonal skills, driving productivity and process optimization.
Overview
12
12
years of professional experience
3
3
Certifications
Work History
Quality Assurance Manager
FUJIFILM Irvine Scientific Inc.
06.2021 - Current
- Led and developed the Quality Assurance team, ensuring compliance with cGxP regulations and industry standards.
- Investigated customer complaints, performed root cause analysis, and implemented corrective actions to resolve quality issues.
- Managed internal and external audits (supplier, customer), including supplier qualification and audit execution.
- Developed and implemented a robust Quality Management System (QMS), aligning with regulatory guidelines and best practices.
- Collaborated with cross-functional teams to integrate quality assurance principles into product development and process improvements.
- Acted as the primary QA representative for CAPAs, Non-Conforming Events (NCEs), deviations, Change Control, and OOS investigations.
- Conducted risk assessments and process audits to identify potential quality issues and ensure compliance with industry standards.
- Established and monitored quality metrics, generating reports to track trends and improve Quality System effectiveness.
- Managed supplier relationships, ensuring raw materials met quality standards, and implemented a supplier scorecard system to enhance performance.
- Oversaw the creation, review, and approval of GMP documentation, including SOPs, validation protocols, and COAs.
- Provided training and mentorship to staff, ensuring adherence to quality assurance best practices and regulatory standards.
- Led Quality Management Review meetings, evaluated KPIs, and escalated issues to senior management for resolution.
- Recruited, supervised, and mentored a team of qualified individuals, focusing on performance management, succession planning, and employee development to retain top talent.
- Played a key role in implementing ERP SAP, including performing user acceptance testing (UAT) and supporting system integration.
- Facilitated site inspections, audits, and regulatory reviews, ensuring compliance with FDA, ISO, and other regulatory agencies.
- Managed budgeting for QA and validation activities, including performance-based assessments and resource allocation.
Incoming Quality Assurance Supervisor
PCI Pharma
04.2021 - 06.2021
- Oversaw incoming inspection processes for raw materials, ensuring compliance with cGMP standards.
- Managed the quality control team responsible for approving or rejecting materials based on internal specifications and industry regulations.
- Developed and implemented inspection procedures to improve material qualification efficiency and accuracy.
- Coordinated with suppliers to resolve material non-conformances and ensured corrective actions were taken.
- Trained staff on inspection protocols and quality assurance procedures to maintain high compliance standards.
- Conducted risk assessments for materials with potential quality issues and implemented appropriate action plans. Boosted customer satisfaction by promptly addressing concerns, investigating root causes, and implementing corrective actions.
- Monitored testing processes, test development and user acceptance testing.
- Enhanced team performance by providing regular training, feedback, and guidance to Quality Assurance staff.
Quality Assurance Compliance Specialist
Wuxi AppTec / Wuxi Advanced Therapies Inc.
01.2021 - 03.2021
- Stayed current with updates to GXP, including FDA, EU, and other regulatory bodies, as well as guidance documents such as ICH and ISPE.
- Compiled and reviewed raw data, batch records, laboratory test results, Final Reports, and COAs, ensuring compliance with cGMP, GLP, CFR, and internal procedures. Investigated and explained any observations or deviations.
- Acted as the QA representative for reviewing and approving Non-Conforming Events (NCEs), deviations, out-of-specification (OOS) results, and CAPA. Provided coaching and mentorship on technical writing skills for personnel.
- Led and participated in internal audits, client audits, supplier audits, regulatory inspections, and state audits.
- Collaborated with management and directors in the creation and annual revision of the Quality Management System (QMS), and ensured site adherence to Quality Systems.
- Conducted timely reviews of complex study files, including Assay Validations, Process Validations, and Viral Clearance studies.
- Maintained awareness of laboratory and manufacturing activities through direct observation and regular interaction with operations and facility staff to ensure quality standards were upheld.
- Performed trend analysis and reported on quality metrics, assisting management with training new hires.
- Authored and revised SOPs as necessary, ensuring documentation stayed current and in compliance.
- Reviewed and approved document change requests to ensure accurate control of records.
- Conducted QA inspections, including, but not limited to, GLP studies, to verify compliance with regulations.
- Participated in quality and process improvement initiatives, working with project teams to drive efficiency and compliance. Reduced instances of non-compliance through meticulous monitoring of internal controls and periodic audits.
- Evaluated existing policies regularly, identifying areas for improvement and recommending revisions as needed.
- Performed quality reviews to uncover workflow and communication issues.
- Worked closely with legal counsel to address any instances of non-compliance or potential violations promptly.
Quality Assurance Manager
EMSL Analytical Inc.
08.2017 - 12.2020
- Managed all aspects of QA and audit activities (Internal & External) for both cGMP and non-GMP laboratories.
- Conducted internal audits and test method assessments to ensure compliance with regulatory standards.
- Led regulatory and customer audits, including those from NJDEP, PADEP, NYDOH, FDA, A2LA, and AIHA.
- Collaborated with management and directors to create and annually revise the Quality Management System (QMS).
- Provided QMS training to staff and took responsibility for quality planning and continuous improvement.
- Led corporate management reviews with QA and ensured proper execution of the process.
- Managed supplier qualification reports, corporate document control, and control of records procedures.
- Oversaw the Environmental Monitoring Program and ensured timely data collection and reporting.
- Played a key role in setting up the cGMP micro-testing lab to ensure compliance with industry standards.
- Wrote, reviewed, and approved SOPs, bench sheets, IQ/OQ/PQ protocols, and lab result reports.
- Conducted equipment validation, calibration, and verification activities, ensuring all instruments were compliant.
- Managed non-conformance, CAPA systems, investigations, and client complaints to maintain quality standards.
- Prepared investigation reports and conducted root cause analysis, ensuring timely CAPA implementation and closure.
- Liaised with customers to ensure their requirements were consistently met and maintained satisfaction.
- Facilitated CAPA tracking and effectiveness checks, ensuring timely resolution and closure of investigations and deviations.
- Implemented QC procedures in line with FDA, ISO 17025, A2LA, and EPA guidelines and mentored staff on SOP updates.
- Managed external proficiency testing (PTs) and ensured compliance with regulatory certifications.
Microbiologist/Quality Assurance Supervisor
IEH Inc.
04.2013 - 07.2017
- Administered the IEH Quality Management System in compliance with ISO/IEC 17025, GLP, and cGMP standards.
- Maintained quality records, SOPs, and related documentation to ensure alignment with QA systems.
- Trained lab technicians on quality systems, including SOPs, QAPs, and test methods.
- Conducted internal and external audits, ensuring compliance with ISO/IEC 17025 guidelines.
- Implemented CAPA processes and performed root cause investigations to resolve quality issues.
- Addressed customer non-conformances, ensuring timely resolution and corrective actions.
- Performed microbiological analysis on various samples for pathogens, like E. coli, Salmonella, and Listeria spp. using multiplex PCR.
- Conducted analytical tests, including RT-PCR, ELISA, DNA/RNA isolation, and UV spectrophotometry.
- Performed bioburden, antimicrobial effectiveness, and bacterial endotoxin testing.
- Carried out environmental monitoring through air sampling, contact plates, and surface swabs in sterile and non-sterile areas.
- Enhanced laboratory efficiency by streamlining sample processing and implementing new testing procedures.
- Maintained electronic test records, issued certificates of analysis, and ensured prompt reporting via LIMS software.
- Verified lab equipment and managed inventory for testing purposes.
Education
Master of Science - Regulatory Affairs And Quality Assurance
Temple University
Philadelphia, PA 05.2001 -
Post Graduation Diploma - Environmental Science
Maharaja Sayajirao University
India 05.2001 -
Bachelor of Science - Biotechnology
Saurashtra University
India 05.2001 -
Skills
- Internal & External Auditing (ISO 9001, ISO 13485, cGMP, GLP, FDA, ISO 17025)
- CAPA Implementation and Root Cause Analysis
- Quality Management Systems (QMS) and Supplier Qualification
- Change Control System and Good Documentation Practices (GDP)
- Continuous Improvement and Process Optimization using Six Sigma and Lean Methodologies
- Team Leadership and Mentoring
- Risk Analysis and Mitigation
- Project Management
- Regulatory Compliance Expert (FDA, ISO, cGMP)
- Problem Solving and Decision Making
- Training and Development
- Planning and Organizing for Quality Initiatives and Work Planning and Prioritization
Software
SAP
MasterControl
ZenQMS
SensoScientific
Salesforce
Certification
HACCP
Timeline
Quality Assurance Manager
FUJIFILM Irvine Scientific Inc.
06.2021 - Current
Incoming Quality Assurance Supervisor
PCI Pharma
04.2021 - 06.2021
Quality Assurance Compliance Specialist
Wuxi AppTec / Wuxi Advanced Therapies Inc.
01.2021 - 03.2021
Quality Assurance Manager
EMSL Analytical Inc.
08.2017 - 12.2020
Microbiologist/Quality Assurance Supervisor
IEH Inc.
04.2013 - 07.2017
Master of Science - Regulatory Affairs And Quality Assurance
Temple University
05.2001 -
Post Graduation Diploma - Environmental Science
Maharaja Sayajirao University
05.2001 -
Bachelor of Science - Biotechnology
Saurashtra University
05.2001 -
HACCP
Six Sigma White Belt
Six Sigma Yellow Belt
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