Judy Tran
Kashiv Bioscience
Piscataway,NJ
1
Certification
24
years of professional experience
Quality assurance professional with comprehensive background in ensuring highest standards of product quality. Proven ability to identify and address defects while maintaining strong focus on collaboration and results. Reliable and adaptable team player with skills in test planning, execution, and problem-solving, ensuring seamless adaptation to evolving project requirements.
Work History
QA Specialist III
1 Year 6 Months- Provide QA oversight of laboratory and manufacturing-support activities to ensure compliance with cGMP, GDP, SOPs, and established quality systems.
- Perform quality review and approval of analytical testing data and supporting documentation for raw material release/rejection.
- Review and approve stability reports, analytical methods, specifications, and Certificates of Analysis (CoAs).
- Conducted GMP walkthroughs, floor/area spot checks, SOP and formbook reviews, and Material Impact Assessments to identify and address compliance gaps, enhancing quality risk management.
- Provided technical input during investigations and corrective actions to enhance QA standards.
- Collaborated with Manufacturing, QC, QA, Regulatory, and other stakeholders to resolve quality issues, facilitating timely business decisions.
- Maintain QC laboratories in an audit-ready state and participate in internal audits, regulatory inspections, and external audits.
- Serve as a QA Subject Matter Expert (SME) for QC laboratory operations and provide guidance on quality and compliance matters.
- Mentored and trained QA Specialists I and II, providing coaching and oversight to improve daily quality activities.
- Review controlled documents and provide recommendations for SOP and process improvements to strengthen compliance and operational efficiency.
Analytical Specialist
7 Years 10 Months- Collaborate with contract laboratories to resolve analytical issues, review quotations, negotiate services, and ensure on-time testing to support production.
- Initiated, tracked, and coordinated change controls, ensuring cross-functional review and timely closure to maintain project timelines.
- Oversee more than 500 DEA and non-DEA reference standards and impurities, reducing the reference standard budget by approximately 30%.
- Collaborated with contract laboratories to resolve analytical issues, reviewed quotations, negotiated services, and ensured on-time testing to support production schedules.
- Managed outsourced testing processes, including purchase orders and invoice approvals, while facilitating communication with manufacturing and external laboratories.
- Utilized SAP to create and process purchase requisitions (PRs) and purchase orders (POs), maintain material master data, and support timely procurement of materials in compliance with GMP requirements.
- Coordinate with import/export teams to ensure compliant shipment and receipt of DEA and non-DEA materials.
MS&T Specialist
3 Years 4 Months- Supported method verification, validation, troubleshooting, and technical investigations, ensuring compliance for developmental and commercial products.
- Perform raw material testing using USP, EP, BP, and JP methods, while maintaining and calibrating laboratory instruments.
- Conduct reverse-engineering studies to identify excipient composition and support product characterization.
- Prepare technical reports, protocols, presentations, and review scientific literature to support project execution.
- Drove continuous improvement initiatives that enhanced Quality Control processes and increased operational efficiency.
Senior Analytical Chemist
11 Years 7 Months- Performed analytical method transfers, validations, finished product testing, and stability testing for commercial pharmaceutical products in a regulated GMP environment.
- Reviewed analytical data, laboratory documentation, logbooks, and instrument calibration records for accuracy and compliance.
- Reviewed analytical data, laboratory documentation, logbooks, and instrument calibration records to ensure accuracy and regulatory compliance.
- Supported laboratory investigations and troubleshooting efforts, providing technical recommendations that enhanced product quality and compliance.
- Trained and mentored new chemists on analytical methods, GMP practices, documentation, and laboratory procedures.
- Trained and mentored new chemists on analytical methods and GMP practices, fostering adherence to documentation standards and laboratory procedures.
- Participated in Lean/MPS and Safety Kaizen initiatives to improve quality, operational efficiency, and workplace safety.
Education
Bachelor of Science - Chemistry
Skills
CGMP compliance
GDP
QA oversight
Deviation investigations
CAPA
Quality metrics reporting
Document control
Quality documentation review
Raw material release
Audit & inspection support
Stability
Laboratory quality systems
Certification
- Six Sigma Yellow Belt – Merck
- Train the Trainer – Schering-Plough
- Deviation Investigations & CAPA – NSF
- Project Management Certificate – eCornell University
- Accounting Certificate of Achievement – Middlesex County College
Timeline
QA Specialist III
Kashiv Bioscience
02.2025 - CurrentRead More
Analytical Specialist
Teva
04.2017 - 02.2025Read More
MS&T Specialist
Allergan
12.2013 - 04.2017Read More
Senior Analytical Chemist
Merck
03.2002 - 10.2013Read More
Fairleigh Dickinson University
Bachelor of Science from Chemistry
Read More