Manager Quality Assurance

MERCEDES R. LOPEZ

PROFESSIONAL EXPERIENCE

CONTRACT QUALITY ASSURANCE / COMPLIANCE October 2007 - present

Tenex Health – Senior Doc. Control Manager; QA Compliance; Lead Auditor (August 2017 – present)

Championed product quality by enforcing quality assurance policies and procedures

Scheduled, assembled teams and conducted internal audits; served as the company’s lead auditor; provided guidance to company personnel regarding resolution of issues related to internal audits and CAPAs

Served as CAPA Program Manager and chaired the CAPA Review Board; managed and trended CAPAs

Managed supplier quality

Managed change control and document control

Participated in Design Risk Management activities

Supported MRB and Complaints

Rescop, Inc. – QA GxP Compliance Consultant and Software Support (November 2016 – August 2017)

Assessed current SOPs and systems to ascertain the level of compliance currently and place and to identify gaps

Performed gap analysis of currently systems and procedures to propose remediation strategy

Built user, functional, and system requirements, traceability matrix and work flow diagrams for potential new electronic systems for Document Management (DMS), Laboratory Information Management (LIMS), Manufacturing Execution (MES), Batch Records (EBR) and Lab Notebooks (ELN) by conducting on-site interviews with business process owners and subject matter experts

Evaluated GxP procedures and records in order to ensure inclusion with specifications requirements under development

Developed system requirements documentation scheme to support multiple electronic systems

Developed workflow diagrams and built traceability matrix that support system integration for paperless QA and QC processes

Provided consulting and auditing services to Rescop global clients to ensure GxP and ISO compliance, including: Gap Analysis, CAPA, User Requirements, Internal & External (Supplier)Auditing, Supplier Qualifications, Document Management, Training, Deviations, and SOPs.

Imprimis Pharmaceuticals – QMS Documentation / Compliance Manager (Eastridge Staffing: March 2016 – November 2016)

Directly responsible for the Document Management processes

Planned, coordinated, and executed quality systems activities including enforcing cGMP

Conceptualized, developed and implemented a manual document control system and the subsequent conversion to a digital document management system

Developed User, Functional and System requirements to convert from manual Document Management to a paperless system

Trained personnel on use of electronic documentation management

Coordinated communication with regulatory agencies (FDA and Boards of Pharmacy)

Epic Sciences – Document Control Specialist (Eastridge Staffing: November 2015 – February 2016)

Streamlined document control systems, including the improvement of existing databases to manage information

Managed the processing and releasing of new and revised documents

Improved the Quality Management System by creating databases to track information, such as Document Change Requests

Cosmederm Biosciences – Quality Engineer (Aerotek Staffing: June 2015 – November 2015)

Directly responsible for the Quality Management processes including supplier qualifications and part numbering systems

Planned, coordinated, and executed quality systems activities including enforcing cGMP

Ensure that quality issues and defects are appropriately identified, documented, tracked and resolved

Manage internal and supplier/contractor audits

Review and process batch records

Provide support and guidance to Marketing team

Prepared formula specifications

Managed the processing and releasing of new and revised documents

Improved the Quality Management System by creating databases to track information, such as Document Change Requests

Zimmer Dental - Regulatory Affairs Associate at (Canon/Adecco Staffing: December 2014 – March 2015)

Conducted internal audits of various departments and manufacturing locations to ensure compliance with internal QMS processes as well as with external international and domestic regulatory standards. As ISO 13458 (medical devices) Lead Auditor responsibilities included:

o writing audit plan

o reviewing previous audit findings and CAPAs

o delegating team assignments

o scheduling team meetings to discuss and document observations

o approving or writing the final audit report in a timely fashion

o determining findings, observations, and future audit considerations (including random spot inspections of work instructions, batch records, routers, safety, calibrations, training, etc.)

o analyzing facts or circumstances surrounding individual problems to determine corrective and preventive action within the limits of standard practices

o scheduling / facilitating the opening and closing meetings and initiating corrective actions

Assisted with organizing data for making part numbers obsolete and entry into the Regulatory Affairs obsolescence database

Assisted with the hosting of external international audits; and the management of the “back room” to collect requested data

Glanbia Nutritionals - Document Control/Quality Assurance Associate (Medix Staffing: May 2014 – September 2014

Worked closely with QA team to prioritize information for immediate customer requests

Updated ingredients from raw material suppliers

Worked with suppliers, manufacturers and the Procurement Department to maintain current technical documentation

Monitored supplier documents for changes

Managed the corrective actions process within the QMS with a priority on cross-departmental communication

Managed the document and change control processes

Maintained raw material technical documentation in PDM

Created company technical documents including ingredient documentation, gleaning information from SAP and PDM

Reviewed and reconciled documentation necessary for material evaluation

Assisted in the development and drafting of written procedures that govern quality and regulatory practices

Identified potential issues regarding internal procedures and took the initiative to recommend solutions

Established governance of controlled documents, including cataloging version numbers, revisions, etc.

Expert Chemical Analysis – Document Control Manager/Acting QA/RA Manager – Consultant (self: Oct.2007-May2014

Improved compliance after FDA audit; hosted subsequent FDA and client audits

Audited the Quality Management System with a focus on change control and documentation, recommended improvements, and implemented improvements

Scheduled internal audits and calibration timelines for equipment

Took ownership of ongoing administration needs, including the writing of SOPs and control of Lab notebooks

Recommended and implemented enforcement of procedures to maintain compliance with regulatory standards

Created office systems and procedure protocols, including developing Standard Operating Procedures and training

Represented the company at professional conferences

ACE RELOCATION SYSTEMS, INC., San Diego, CA January 2012- October 2012

Executive Support Lead (for Owner/SVP Operations)

Planned, managed, and supported logistics for management summit, including guest speakers and presentation materials

Performed competition analysis for top management

Analyzed and reported on trends for KPIs; Reviewed internal operations procedures to identify areas for improvement

Managed expense accounts for 15 van operators

Designed and published company newsletter

UCSD JACOBS SCHOOL OF ENGINEERING, La Jolla, CA December 2005- December 2010

Various paid student positions (Teacher’s Assistant, Summer Intern, Paid Team Leader)

Interviewed and supervised research project candidates, assembled team, coordinated proposal, delegated tasks, and liaison

Presented research at symposia for year-long paid research project

Provided support to professors coordinating a focus group and designed pilot project for teachers to use in the classroom

Designed demonstrations for elementary and middle school classrooms presented by Teams In Engineering Service (TIES)

Graded student laboratory notebooks in Engineering 100 course and held office hours to support and coach students

Provided coordination support for a summer workshop at Duke University; additional author on resulting publication

CITY COLLEGE, San Diego, CA September 2003- May 2005

Peer Tutor, Math Science Engineering Achievement (MESA) Program and TRIO-Aspire Program

Tutored students in math through Calculus, Spanish, French, English Composition, and General Chemistry

JOHN BURNHAM INSURANCE SERVICES, San Diego, CA November 2001- August 2003

Document/Publications Specialist

Provided support for six primary insurance producers and created proposals for submission to potential clients

AGOURON PHARMACETICALS (PFIZER INC.), San Diego, CA August 1998- November 2001

Regulatory Affairs Analyst/Advertising & Promotion (Viracept and Rescriptor)

Liaison between Marketing Dept. and FDA regarding advertising and promotional materials for HIV prescription medicines

Interfaced with FDA/DDMAC (OPDP) regarding the status of advertising and promotion materials being reviewed

Project manager responsible for coordinating across departments for submission to FDA, including INDs and NDAs

Coordinated and facilitated between Marketing, Legal, and Regulatory Depts. to review ad & promo materials

Monitored status of materials in the review process, including internally and those submitted to FDA for approval

Proofread advertising and promotional materials and negotiated with OPDP on behalf of the company

CORVAS INTERNATIONAL San Diego, CA February 1997- August 1998

Document Control Specialist, Quality Assurance and Regulatory Affairs Assistant

Saved the company over $200K in consulting, labor, and training by designing and implementing a purchasing database

Co-created the Quality Management System with a focus on the Document Control Unit

Coordinated creation and printing of labels for clinical trials; Received and logged clinical trial samples

Coordinated the schedules for shipping, receiving, and testing of clinical trial samples

Assisted with the coordination of receiving all the components from various departments for regulatory submissions

Assisted with the creation, editing, formatting, and tracking of regulatory submissions.

Coordinated schedules for calibrating pipettes and other scientific equipment

Created a database to monitor the status of patent documents

CANJI, Inc., San Diego, CA October 1995-January 1997

Document Control Specialist

Assisted with the creation of the Quality Management System and Document Control Unit

Interfaced with Regulatory, Clinical, Process Sciences, Toxicology, Pharmacology, Safety, and Facilities Departments

Formatted toxicology reports and other documents

Created various databases to facilitate the generation of reports

SKILLS and AFFILIATIONS

Certificates: ISO 13485 Lead Auditor (2015-2017)

Technical: Mac and PC fluency in the entire Microsoft Suite; FileMaker Pro; Quark Xpress; PageMaker; Adobe Photoshop, Illustrator; iCal, Google Docs, QuickBooks, Familiar with HTML and Java, AVID, PDM and SAP

Languages: Bilingual English/Spanish (fluent)

Member: American Society for Quality; previous member: Society of Women Engineers, Regulatory Affairs Professional Society, Society of Hispanic Professional Engineers

Soft skills include:

Ability to foresee and prevent potential complications

Creative problem solving talents using data to inform decisions

Ability to think and work fast

Amazing reporting and research skills

Natural leader; support the team, and organize to successfully manage a high workload

Strong communicator across teams (Design, Product Development, Cutting, Sewing, Finishing, Customer Love), and comfortable working directly with senior leadership

Exceptional communication

PUBLICATIONS

Engaging Middle School Teachers and Students with Alice in a Diverse Set of Subjects; Susan H. Rodger, Jenna Hayes, Gaetjens Lezin, Henry Qin, Deborah Nelson, Ruth Tucker, Mercedes Lopez, Stephen Cooper, Wanda Dann and Don Slater, Fourtieth SIGCSE Technical Symposium on Computer Science Education, p.271-275, 2009. pdf

EDUCATION

Bachelor’s Cognitive Science, University of California San Diego (UCSD) – 2010. Recipient of multiple scholarships

Associate’s Liberal Arts, San Diego City College – 2005. High honors, Recipient of multiple scholarships. Phi Theta Kappa officer (Honors Society) - Fundraising and Public Relations Director (Student Officer Position)

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