Clinical Quality Manager

• Jun 2022 - Present

Responsible for building a scalable clinical quality function to ensure clinical trials are conducted in compliance with GCP, ICH and all applicable federal guidelines. • Develop and support quality systems to support clinical study teams • Establish and maintain effective strategies, systems, and procedures ensuring compliance with applicable GCP standards • Assist with quality review of clinical data • Create Standard Operating Procedures and Work Instructions • Lead external audits and support clinical vendor qualifications • Lead company readiness for GCP and Regulatory inspections • Review clinical documents for compliance • Represent Global Clinical Operations in internal process audits • Develop CAPA plans and investigations in response to audits and inspections, and ensure findings are remediated Show less

Senior Clinical Quality Associate

• Aug 2021 - Jun 2022

Responsible for planning, executing, managing, and closing projects associated with the company clinical study plans. The Senior Clinical Quality Associate will partner with the clinical affairs team to drive clinical quality assurance activities to include internal, vendor, and site audits, SOP development and review, and process improvement. The Senior Clinical Quality Associate will serve as a quality subject matter expert to clinical affairs project teams for adherence to quality and compliance standards and will provide support to members of multidisciplinary project teams, both internally and externally. • Provide guidance to clinical affairs to ensure adherence to all regulations, guidelines, SOPs, and local, regional, and national requirements. • Draft, review, and revise clinical SOPs and assess consistency across internal processes, Good Clinical Practice, and regulations. • Review of study documents prior to finalization; including protocols, informed consent forms, protocol amendments, and project plans. • Partner with contract research organizations, vendors, and external collaborators to assess and maintain GCP compliance. • Participate in quality investigations; including CAPA plans and root cause analysis. • Lead clinical audits of CROs, sites, vendors, system validation, and internal processes. • Collaborate with clinical study managers to develop study-specific site audit plans. • Contribute to study risk assessment plans and mitigation. • Perform inspection readiness activities and support regulatory inspections. • Participate in cross-functional project or program level meetings to provide clinical quality recommendations. • Act as a customer advocate throughout the project lifecycle. Show less

QA Compliance Auditor

• Nov 2019 - Aug 2021

• Audits protocols, phases of clinical studies, reports, across all disciplines in compliance with appropriate SOPs, and regulatory standards. • Hosts and coordinates preparations for client audits and regulatory inspections. • Acts as an expert and provides guidance on regulatory compliance issues. • Drives improvement in the Quality Assurance (QA) organization as well as in the Operations practices. • Presents training on specific GCP topics and mentors less experienced auditor. • Audits protocols, phases of clinical studies, reports, across all disciplines in compliance with appropriate SOPs, and regulatory standards. • Hosts and coordinates preparations for client audits and regulatory inspections. • Acts as an expert and provides guidance on regulatory compliance issues. • Drives improvement in the Quality Assurance (QA) organization as well as in the Operations practices. • Presents training on specific GCP topics and mentors less experienced auditor.

QA Laboratory Systems Supervisor

• Feb 2019 - Nov 2019

Provide Quality Assurance oversight to the Laboratory, Filling and Packaging Departments. • Perform Compliance Gap Analysis. • Develop and follow up Compliance Plan action items. • Procedural improvements by SOP re-writes to improve quality, compliance and efficiency. • Laboratory metrics to track efficiency and to identify areas of improvement. • Facilitate Laboratory NOI’s and CAPA’s closure. • Facilitate investigations of failures and deviations. • Facilitate the change management program. • Laboratory Process improvement. • Process and systems training. • OOS review and approval. • Non-conforming materials investigation. • Validation oversight and development. • Work with R&D and Operations to determine and maintain formula families as a risked based approach to validation. • Supervise direct reporting staff according to overall company policy. Set employee goals and objectives and develop staff to maximize potential. Show less

Senior Quality Assurance Auditor

• Apr 2017 - Jan 2019

QA Auditor

• Jan 2015 - Apr 2017

Carry out auditing of study, project, and process reports, records and data; report audit findings to operations.Perform GLP and GCP audits.Perform in-process inspections of study phases and methods. Review study events, deviations, investigations and change control documentation; and assess acceptability of content and documentation.Interact with internal and external clients to discuss QA observations and study related issues; and maintain effective and professional working relationship within and across departments in relation to study projects.Developed departmental metrics to be presented to management.Develop a training program and matrix and train associates.Manage auditors, perform reviews and employee evaluations. Show less

QC Microbiology Analyst

• Nov 2013 - Jan 2015

Perform complex microbial analysis and assist in Validation and GMP review.• Use microbiology techniques to test raw materials, finished product, and packaging supplies.• Perform environmental monitoring according to written procedures and test methods.• Own CAPA records and assess Objectionable Organisms to support Laboratory Investigations.

QA Auditor/Analyst

• Nov 2012 - Nov 2013

Ensured production activities within Manufacturing and Packaging were conducted according to Standard Operating Procedures, and in compliance with cGMP.• Handled deviations and CAPA Effectiveness Verifications in Trackwise System.• Reviewed and approved Batch Record documentation, Validation Protocols and Reports.• Supported the Regulatory Compliance Department as part of the FDA Commitments response team, and as the QA reviewer and runner during FDA inspections.

Sr QA Associate

• Aug 2011 - Oct 2012

Provided support and oversight to production activities by being the Quality presence on the floor during the batch packaging process. • Performed in-process sampling and visual inspection of product and packaging components. • Performed online and offline review and approval of packaging batch records’ GMP documentation on paper and using Electronic Batch Record System. • Audited packaging lines cleans and clearances. • Handled deviations to procedures and generated non-conformances in Trackwise System. Show less

QA Documentation Technician

• Jan 2009 - Aug 2011

Provided support and oversight to Production activities by being the Quality presence on the floor during batch manufacturing. • Audited batch records and logbooks to ensure GMP and SOPs are followed; and trained new QA Technicians in these tasks. • Performed preventive walks to audit manufacturing areas. • Gave disposition and managed status of manufacturing batches using SAP and R6 systems. • Performed statistical sampling to solid products. • Worked in a Consent Decree environment. Show less

Laboratory Technician and Research Assistant

• Feb 2003 - May 2007

Prepared, evaluated, and offered the Biology and Microbiology Laboratory Course. • Helped in the coordination of the laboratory course. • Taught students all the basic microbiology techniques (microscope use, cell culture, plate count, water analysis, Api test, etc.) Worked in a Neurobiology, Microbiology, Immunology and Developmental Biology Laboratory. In charge of the Microbiology and Immunology area, grants administration, laboratory inventory. • Produced, purified and tested monoclonal antibodies. • Purified and identified proteins using Gel Electrophoresis, Western Blot and Immunohistochemistry. • Used histology techniques, tissue preparation, and dissection. • Cultured and identified cell and tissue samples. • Trained new hires and students. Show less

QA Laboratory Technician

• Jan 2002 - Sep 2002

Maintained the Chemistry QA Laboratory. Calibrated the laboratory equipment and solution preparation. • Performed basic chemistry laboratory procedures. • Implemented a new samples disposal plan. Maintained the Chemistry QA Laboratory. Calibrated the laboratory equipment and solution preparation. • Performed basic chemistry laboratory procedures. • Implemented a new samples disposal plan.