Document Control Quality Assurance

Summary of Qualifications:

●**+ years of experience working under CLIA, CAP and NY state regulations. 4+ years of experience working under DQS regulations. GMP, GCP, GMED and FDA experience.

●4+ years of training experience (training new hires) and building curriculums for each department.

●Built, implemented and validated Electronic Document Management Systems for 3 companies.

●20+ years as Subject Matter Expert for Document Control during audits for each company.

Experience:

Jul 2023- Present

Document Control & Training Calico Life Sciences South San Francisco, CA

Responsibilities include and not limited to: Promote Calico’s quality culture by managing innovation and periodic review of GxP governance documents (e.g. policies, SOPs, templates). Provide expert input with respect to document planning, format, structure, and content. Execute document change controls. Work with cross functional groups to evaluate training, develop and maintain training matrices, and drive training completion timeliness. Deliver the right training to the right people at the right time utilizing multiple platforms (e.g. in-person, e-learning, webinars). Enhance document-management and training systems (e.g. Vault, DocuSign) and maintain the validated state. Lead enhancements to improve efficiency. Implement and ensure compliance with record retention timelines. Track procedural gaps and enhancements to closure. Work independently to innovate processes and make continuous improvements to the quality management system. Review documents such as quality agreements, plans, and reports. Provide guidance to ensure compliance with applicable regulations. Support internal and external health authority inspections. Perform a wide variety of activities to improve delivery of quality objectives.

Jan 2023- Jun 2023

Senior Manager, Document Control Manager Rain Oncology, Inc. Newark, CA

Responsibilities include and not limited to: Management and continuous improvement of Rain’s Quality Management System under the guidance of the VP of QA. Management and continuous improvement of electronic quality systems in compliance with QS, CLIA, GxP and other applicable regulations and guidelines. Management and maintenance of Rain’s document control system (act as Veeva Business Administrator and DocuSign administrator); processing and technical editing of QA controlled documents (e.g. SOPs, Forms, Policies) including project/product-specific documents. Trending and analysis of key quality metrics. Implementation and management of GxP training programs as the administrator in ComplianceWire (LMS). Maintain and review batch records for manufacturing lots, studies, deviations, non-conformances, CAPAs, investigations, and complaints. Maintain files for internal and external audits. Perform duties as the lead Business Partner Administrator for Veeva in designing and implementing the EDMS modules (adding metadata fields, modifying user rights, development of the API integration with the LMS, adding fields for future integration of QMS modules) to meet the needs of Rain. Assist in gathering and maintaining the files for NDA filing.

Sep 2022-Dec-2023

QA Analyst, (CDx) QSR Quality Systems Labcorp, Inc. (Monogram) South San Francisco, CA

Responsibilities include and not limited to: Management and continuous improvement of Monogram’s Quality Management System under the guidance of the QA Manager or Director. Management and continuous improvement of paper and electronic quality systems in compliance with QS, CLIA, GxP and other applicable regulations and guidelines. Management and maintenance of Monogram’s document control system; processing and technical editing of QA controlled documents (e.g. SOPs, Forms, Policies) including project/product-specific documents. Trending and analysis of key quality metrics including nonconformance data. Review and tracking of CAPA action items. Assisting in the investigations and determination of root causes. Implementation and management of training programs. Primary support for Monogram Audit (Host) Team; coordinating with other functional areas to obtain materials, documents, records and other similar references requested during audits and inspections.

May 2019-Jun. 2022

Quality Assurance Manager Natera, Inc. San Carlos, CA

Managed 6-8 direct reports within 2 separate groups at the same time (Document Control and Quality Training team). Set up processes for the Document Control group and Quality Training Management group. Support in Pharma and Regulatory audits (GMED, CAP, CLIA and NY State). Completed NCRs, CAPAs and Deviations. Help evaluate, validate and maintain the new Electronic Document Management Systems (EDMS). Write up SOPs and validation protocols and reports for validating the EDMS (DotCompliance). Update and write procedures for Document Control and Training departments. Advise in writing procedures around Design Control for IVDR submissions. Maintain DHF files and manage documentation around Regulatory submissions. Set up metrics to measure the efficiency and report to management for Document Control and Training processes. Process documents (set formatting, file naming convention, punctuation, etc.) and set up document metrics. Organize and categorize the company’s documentation from a paper based system. Assist in writing up goals and assigning set roles for Document Control. Business Partner administrator for Veeva Vault, DocVault and DotCompliance.

Dec. 2015-May 2019

Document Control Manager BioQ Pharma, Inc. San Francisco, CA

Validated and maintained the Electronic Document Management Systems (EDMS). Design Custom forms in MasterControl using Excel and Javascript coding for use in the automation of Quality Management System (QMS). Assist in US FDA and DQS audits. Assist in Regulatory filings in Europe, US, China (specifically Hong Kong, Macau and Beijing), Australia, Arabic Nations (Saudi Arabia, Kuwait, Qatar, UAE), Ukraine and Africa (Morocco). Designed Sharepoint sites on Office 365 for various Marketing teams and Global Partners. Review batch records of contract manufacturers. Process documents (set formatting, file naming convention, punctuation, etc.) and set up document metrics.

Sept. 2002-Dec. 2015

Senior Document Control/QA Specialist Genomic Health, Inc. Redwood City, CA

Document control tasks: Create, review and modify standard operating procedures (SOP). Uphold CLIA regulations, under 21 CFR 11, when reviewing SOPs. Process SOPs for use in clinical laboratory. Prepare and organize SOPs for CLIA, NY State and CAP inspections. Utilizing in-house designed software (CRM, SARP, Material Manager and GEMTools LIMS systems) in the following tasks: Laboratory support tasks: Assisted in quality control systems for each reagent used in research and development extraction, reverse transcription and quantitative PCR processes. Commercial tasks: Participated in the designing and testing of the commercial processes. Performing accessioning tasks (receiving patient samples, contacting physicians to complete requisitions, processing and barcode labeling samples). Performing histopathology tasks (preparing H&E slides and sample tubes, staining H&E slides, macrodissecting unstained slides and preparing sample batches for clinical laboratory). Returning sample blocks to client sites. QA tester for IT: Functional (Blackbox) testing of Microsoft CRM, GEMTools, Material Manager and SARP. Member of the Emergency Action Team (Back-up Utilities Control), Support for Receiving and Facilities.

Nov. 2001-Apr. 2002

Technical Product Development Scientist Abbott Diagnostics Division Santa Clara, CA Performed research into HL-60 cell lines (human promyelocytic leukemia), a suspension cell line. Performed cell viability tests and cell differentiation tests on HL-60 cell line and blood samples. Investigative scientist in solving and handling customer complaints with the Cell Dyn machines (blood analyzers). Centrifugation studies on blood samples and blood components. Managing accounts and ordering supplies.

Apr. 2000-Aug. 2001

Lead Production Chemist Protogene Menlo Park, CA

Under GMP guidelines I helped devised various methods and techniques to streamline production and to improve quality of DNA microarrays. In addition, I developed, updated and documented procedures, manuals and SOPs. Assisting the Engineering team, I was involved in extensive troubleshooting and maintaining of automated oligonucleotide synthesizers. Training of new hires.

Oct. 1999-Dec. 1999

Quality Assurance Technician I Lifescan Milpitas, CA

Experienced in handling whole blood in a biohazardous environment, hepatitis B vaccination was required. Assisted in redesigning and revising SOPs. Responsible for validating and releasing materials to internal customers, preparation of standard solutions, and lab maintenance in a GMP environment. Troubleshooting skills were required in analysis of raw data, graphing and formulation of charts for presentation of the raw data. Experience in YSI training, blood gas analysis, and checking HCT and RBC levels. Work under ISO 9000 regulations.

Feb. 1999-Aug. 1999

Clinical Manufacturing Technician Inhale Therapeutics San Carlos, CA

Performed the following duties cleaning, maintenance, assembly and operation of automated filling and spray drying equipment. Perform manual operation such as filling and packaging. Completed inventory control and dispensing activities for GMP raw materials. Collected, maintained and interpreted data on operations performed. Revised, updated and/or developed new processing batch records and SOP’s to support manufacturing operations. Support as needed, process optimization, qualifications and scale-up efforts. Working under a strict FDA regulated environment. Extensive experience in trouble-shooting and operation of automated filling equipment. Work under ISO 9000 regulations.

June 1998-Dec. 1998

Quality Assurance Technician I Lifescan Milpitas, CA

Experienced in handling whole blood in a biohazardous environment, hepatitis B vaccination was required. Assisted in redesigning and revising SOPs. Responsible for validating and releasing materials to internal customers, preparation of standard solutions, and lab maintenance in a GMP environment. Troubleshooting skills were required in analysis of raw data, graphing and formulation of charts for presentation of the raw data. Experience in YSI training, blood gas analysis, and checking HCT and RBC levels. Work under ISO 9000 regulations.

Education:

B.A. Molecular Cellular Developmental Biology, Degree U.C. Santa Cruz 1999

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