Sara Cavanaugh Email & Phone Number

Silver Spring, Md, Us

• Collaborated with CDER/OPQ/OQS staff to develop and perform Quality Management Maturity assessments for establishments worldwide.• Refined assessment protocol and scoring rubric based on industry standards and literature.• Created SOPs, presentations, and reports for distribution within and outside the FDA.

Gaithersburg, Maryland, Us

In my role as a QC Data Review Specialist at Novavax, I was responsible for creating COA and COT documents for global drug releases. I audited raw data from external testing labs, served as a Point of Contact for labs in the UK and India, and completed projects for regulatory filings. I also collaborated with international colleagues daily to ensure project success.

• Acted as the QC Record Owner for deviation, CAPA, OOS, and change control, ensuring successful closure in collaboration with cross functional SMEs.• Conducted detailed investigations, leading to enhanced quality processes and compliance.• Audited manufacturing batch records from an international Contract Manufacturing Site to ensure quality standards were met.

Lexington, Ky, Us

Oversee quality control operations as a primary liaison and SME for testing documentation adherence to Good Documentation Practices (GDP) standards and regulatory guidance for products, processes, and requirements. Review and approve initial process, raw material, intermediate, and finished product, procedures, and reports. Coordinate with teams, including supervisor, operations, analytical group(s), and QA.• Key Project: Created a training module for documentation reviews that unified approach for all reviewers, leading to greater accuracy and faster quality control (QC)• Propose continuous improvements for safety, GMPs, GDPs, or QC efficiency, and communication• Perform analysis and support lab investigations (OOS, deviations, CAPAs, etc.), plus review of a variety of data types, including HPLC, GC, KF, IR, XRPD, ICP, TGA, DSC, and wet chemistry testing• Develop and coordinate events for the site Patient Awareness Committee and the Culture Committee, leading to external partnerships for philanthropic initiatives that cultivated good community relations and brand reputation

New York, New York, Us

Coordinated validation for Chemical Quality, Biological Quality, and Incoming Quality labs. Implemented validation change control during the life cycle of the system, including computerized system validation and system decommissioning. Performed and supported investigations (deviations, CAPAs, etc.) and provided end-user support for all Quality Laboratory groups as well as compliance to global and site internal policies and procedures.• Spearheaded a review program for 300 laboratory instruments by developing a process, leveraging TrackWise and other instrument databases, meeting the FDA-mandated timeline for completion ahead of schedule• Mitigated risk of audit observations by discovering and recommending instruments for replacement to adhere to data integrity guidelines

New York, New York, Us

Managed and audited accuracy of Chemical Quality (CQ) testing reports and records management for domestic- and international-bound products. Reviewed data and chromatography within computer systems. Ensured data compliance with GDP, DEA, FDA, and ICH guidelines, prepared for audits, and performed lab investigations.• Prioritized testing on batch release schedule in the absence of the Analyst Supervisor• Performed technical review of testing to ensure completion of all instrumental techniques (HPLC, GC, UV-Vis, etc.) and wet chemistry techniques (ID, titrations, pH, etc.) according to SOPs, STMs, and the USP• Coordinated between Analyst Supervisors, production and trained new Data Reviewers with performance oversight of up to 10 Technical Data Reviewers

Purchase, New York, Us

Led the new wastewater plant to promote higher standards of testing and water quality, including training plant personnel on testing procedures. Oversaw monthly reporting, analytical product testing and sanitization, and regulatory compliance for pH, carbonation, sugar, acid, alkalinity, and chlorine levels of Pepsi soda products and raw soda syrup.

London, Gb

Performed analytical testing of raw coals, steel grade coke, wastewater, and by-products from coal/coke battery using ASTM and EPA methodology. Prepared samples, reagents, data and statistical analysis, and lab reports. Made recommendations to pause production based on safety and quality standards, as well as OOS/OOT investigation results.

Master Of Science, Integrated Pharmacology

Bachelor Of Science, Biology, Chemistry

Associate Of Science (As), Science

Diploma, Pre-College