Planned and conducted internal audits, supplier audits and facility inspections utilizing ISO 9001:2015 quality tools and techniques ensuring compliance to SOPs, GMP, GCP, GLP and medical device standards. Submitted audit reports with nonconformances, observations and best practices. Reviewed responses and followed up on unsatisfactory responses or CAPAs resulting in no findings during ISO 9001 requalification audits.Managed deviation, corrective action and effectiveness check updates in tracking system. Created a weekly overdue deviation report and led a cross-functional team to close overdue deviations, resulting in an 80% reduction in 6 months.Functioned as single point of contact (SPOC) from QA for instrument/equipment maintenance, qualification, and validation (IQ/OQ/PQ). Collaborated with technical staff on validating an FTIR, XRD, ICP, RI detector, CAD detector, dissolution apparatuses, and multiple LC/MS/MS for GMP compliance.Collaborated on the upgrade of two software systems (Empower and Fishbowl), and validation of Sample Manager for GMP stability samples ensuring compliance to internal procedures, ISO 9001, 21 CFR 210/211 and 21 CFR 11.

Managed audit program conducted internal audits, supplier audits and facility inspections in accordance with GMP, GLP, ISO 9001, and Lean Practices, prepared audit reports, followed up on CAPA activities and conducted/coordinated periodic evaluations of the audit program with general manager.Managed deviation process and collaborated with scientists, project management and clients to meet project deadlines and complete deviations, investigations and CAPAs, resulting in 95% completion within 30 days. Created annual supplier audit schedule, conducted supplier audits/risk assessments, submitted audit observations, and reviewed and evaluated audit responses/assessments for compliance. Managed vetting of new suppliers and updated approved supplier list accordingly.

Managed QA team and coordinated a complete audit of donor center records daily. Performed data analysis of KPIs for tracking and trending to determine areas of improvement. Prepared and presented reports of KPI metrics and other quality assurance issues affecting donor suitability or product quality to regional management, donor center management, and staff during weekly, monthly, and quarterly meetings.Managed hiring, scheduling, creating work plans, and conducting performance evaluations for QA team.Provided guidance, coaching, professional development assistance and QA oversight to all non-management staff.

Reviewed and authored SOPs utilizing knowledge of assay theory and instrumentation in accordance with GCP and CAP/CLIA standards, reducing errors by 20%.Assisted with validation for therapeutic drug monitoring by UPLC (LC/MS/MS). Trained new employees on company policies and procedures.

Communicated with ordering physicians and patients as subject matter expert when questions pertaining to drug metabolism and limits of detection arose.Reviewed and authored SOPs, and trained new employees in standards, laboratory practices and procedures.

Provided basic life support to wounded individuals (e.g., assess airway, breathing and circulation, provide CPR).Provided Advanced Life Support, as needed, for example, intubation, IV insertion, medication administration).