Quality Manager
Resume:
J ouana LaTrell Harris Livings
ASQ CQIA, CQA, CQM
***** ***** **** ****, *******, TX 77075
Cell: 713-***-**** Residence: 713-***-**** accvj0@r.postjobfree.com
Executive Overview
Proficient quality and regulatory professional with vast knowledge of both the biotherapeutics and medical
device industry. More than 10 years of successful utilization of transparent communication to foster customer
focus and quality culture. Immense experience with Standard Operating Procedure composition merging FDA,
other regulatory requirements and ISO standards with efficient implementation. Managed new center openings,
Quality Management System development, domestic and international regulatory affairs, staff mentorships and
training efforts for various businesses.
Area of Expertise
ISO 9001 and 13485, FDA 21 CFR 640 and 820, EU MDD 93/42/EEC, cGMP, Deming Cycle (PDCA),
Deming’s 14 point philosophy, Continuous Quality Improvement (CQI), root cause analysis,
quality training and development
Education and Credentials
2010 – present 2012
California State University Dominquez Hills California State University Dominquez Hills
Pursuing MSQA – anticipated graduation May 2014 Certified Quality Manager (OE)
Xavier University of Louisiana California State University Dominquez Hills
BS Chemistry Certified Quality Auditor
North Shore Senior High American Society for Quality (ASQ)
Diploma, Honors Curriculum Certified Quality Improvement Associate
Professional Experience and Career Highlights
Trilliant Surgical LTD (Houston, TX) FEB 2012 to present
Director of Quality and Regulatory Affairs
Responsible for laying the foundation of a rapidly growing medical device company’s Quality
Management System to include the following: converting starter SOP to one that complies with
FDA’s 21 CFR 820 and that conforms to ISO 13485:2003 standards, creating an OSHA compliant
work environment, initiating internal manufacturing and launching international sales. Conduct internal
and supplier audits. Review device master records and approve final release of product. Oversee various
regulatory projects such as international device license applications, labeling translations, technical file
compilations, and post market surveillance. Successfully achieved ISO 13485 Certification and CE
Mark approval June 2013.
Grifols Biomat USA (Los Angeles, CA) NOV 2010 to JAN 2012
Quality Manager, Central Division
Managed the activities and performance for 6 donor centers’ quality. Hired, trained, and mentored
Quality Supervisors and Associates. Interpreted/clarified company SOP for center staff. Performed
Page 1 of 2
J. Harris-Livings
reviews/audits of center records to assess compliance for executive management. Performed root cause
analyses. Ensured that the quality of the centers complied with cGMP, FDA, EMA regulations and
other industry standards; resulting in 3 successful EMA inspections and 3 centers with zero 483 FDA
inspections.
Talecris Plasma Resources (Research Triangle Park, NC) – OCT 2006 through FEB 2010
Project Insight Conversion Lead (FEB 09 – FEB10)
Created processes/tools to be utilized during companywide SOP Conversion. Reviewed/revised/
updated SOP to ensure that it incorporated cGMP, FDA and GHA regulations, and other industry
standards. Tracked and verified material shipments to all centers. Provided remote support to centers
regarding the SOP Conversion process.
New Center Development Operations Lead (MAR08 – FEB09)
Led team and operational activities associated with the opening of a new donor center. Trained/
mentored center management staff pre and post opening. Acted as Center Manager during
position vacancies. Prepared center for internal, external, and FDA pre-licensing inspections.
Ensured center compliance with cGMP, FDA and GHA regulations, and other industry standards.
New Center Development Quality Lead (OCT07 – MAR08)
Led quality activities associated with the opening of a new donor center. Trained/mentored center
quality staff pre and post opening. Reviewed/audited daily records for periodic center assessments.
Prepared center for internal, external, and FDA pre-licensing inspections. Ensured that the quality of
the center complied with cGMP, FDA and GHA regulations, and other industry standards.
Regional Quality Manager (OCT06 – OCT07)
Managed the activities and performance of the center Quality Supervisors within an assigned region.
Trained/mentored and assessed center Quality Supervisors. Hired/fired center Quality staff.
Interpreted and clarified company SOP for center level staff. Performed periodic reviews/audits of
center records for assessments. Performed root cause analyses. Ensured that the quality of the
centers complied with cGMP, FDA and GHA regulations and other industry standards.
Grifols Biomat USA Plasma (Los Angeles, CA) – MAY 2004 through OCT 2006
Regional Quality Supervisor (APR06 – OCT06)
Assisted Quality Manager in curative actions for assigned region. Performed audits/document review
to assess centers with compliance issues. Performed root-cause analyses. Acted as center Quality
Supervisor during position vacancies. Trained/retrained Quality staff to comply with cGMP, FDA
and EU regulation and other industry standards.
Quality Supervisor (MAY04 – APR06)
Supervised quality component of donor center operations. Performed root cause analyses.
Conducted/responded to internal and external audits. Hosted various center audits. Trained other
Quality staff. Ensured that the quality of the centers complied with cGMP, FDA and EU regulations,
and other industry standards.
Honors/Awards and Professional Organizations
American Scholars Honors Society, Dean’s List, Alpha Kappa Mu Honor Society, All-American Scholars for
College Students, Outstanding Student Award, and ACT Essay Contest Winner. American Society for Quality
(ASQ), Regulatory Affairs Professionals Society (RAPS), American Chemistry Society (ACS), National
Association for the Advancement of Colored People (NAACP), and National Association for Female Executives
(NAFE)
Page 2 of 2
J. Harris-Livings
Contact this candidate