Dominique Barriere has over 8 years of experience in quality assurance roles ensuring compliance with ISO and FDA regulations. She currently works as a Quality Systems Regulatory Compliance Technician for Steris Applied Sterilization Technologies where she is responsible for document control, conducting internal audits, and assisting with corrective and preventive actions. Barriere has a Bachelor's degree in Management from Rutgers University and is an ASQ-certified Quality Auditor.

1. Dominique Barriere
342 Rahway Avenue  South Plainfield, NJ 07080  (908) 380-8428  Dominique.Barriere7002@gmail.com
Profile __________________________________________________________________________________
Motivated, personable GMP/cGMP professional with 8+ years within Quality Assurance
regulated industry. Demonstrated consistency meeting stringent International
Organization of Standardization (ISO) guidelines including practical application of Code of
Federal Regulation 21 CFR 11/ 210/820 and ISO 13485 to ensure continued effectiveness
in satisfying organizational Quality System Management objectives.
Skills Summary __________________________________________________________________________
 Document Control
 Internal Audits
 Written Correspondence
 Attention to detail
 Prioritize Task
 Dealing with
Customer feedback
& complaints
 Training/mentoring
new staff
 Meet project deadlines
 Team player
 Microsoft Office Suite
 ODMS-RT, MyIsomedix
electronic Quality
Assurnace tracking
module, AS400, JD
Edwards
Professional Experience ___________________________________________________________________
QUALITY ASSURANCE: DOCUMENT CONTROL & RETENTION/HEALTH & SAFETY
 Responsible for the review of processing files prior to and after product processing, as well as prior
to product release, in order to ensure processing parameters have been met and issuance of
Certificate of Processing (CoP).
 Conduct internal audits consistent with corporate and facility polices; managetimely completion of
audit including communication of status to QSRC Manager.
 Assist with CAPA Process (Corrective and Preventive Action) as required by nonconformities (NCs) of
customer product, process deviations, procedure deviations, customer complaints (CCs), regulatory
audits, customer audits, and internal audits.
 Ensure that that only current, approved procedures and controlled documents/forms are utilized by
facility personnel.
 Facilitate management of documentation (Batch/customer run records, employee training records)
per established Quality Systems Management (QSM) policies as required for customer audits,
Business Unit/Internal audits, International Organization of Standardization (ISO) audits, and FDA.
 Ensure that documents follow appropriate document retention process according to Quality policies
and regulatory agencies.
 Capture data for monthly Quality ReviewBoard (QRB) to be utilized to trend/chart personnel data
entry errors in process performance improvement and traceability.
 Perform review of operating logs (Ethylene Oxide Gas (EtO, Preconditioning, Aeration) to ensure
timely and accurate record keeping processes.
 Maintain all current and archived documentation electronically and in hard copy, including
temperature and relative humidity charts for Process Areas reporting per procedure.
 Audit all incoming documents, and all other change requests to customer validated specifications to
ensure proper QSM approvals, completeness, and accuracyprior to Production process.
 Make all approved document changes with data management database and distribute appropriately.

2. Dominique Barriere
342 Rahway Avenue  South Plainfield, NJ 07080  (908) 380-8428  DOMINIQUE.BARRIERE7002@gmail.com
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 Responsible for assignment in data management database and review of Drum out List and
Certificate of Analysis (CoA) for all supplier EtO drums & Nitrogen gas: serial number, lot, warranty
and weight prior to and after product processing.
 Collaborate with cross-functional departments to ensure efficient course of action to meet supplier
commitments.
 Participation in development of site safety initiatives in compliance with OSHA standards and local
regulations.
 Communicate and document customer concerns based on established customer
specifications.
 Conducted routine inspections, collecting, identifying, and evaluating evidence for the purpose
of ensuring compliance with property maintenance municipal ordinance.
 Examined records, reports and other documents to establish facts and detect discrepancies,
recording the nature of complaints and field observations providing recommendations for
administrative or legalcorrective action.
 Communicated with property owners to determine conformance and provide information and
guidance in the overall compliance of housing and property maintenance practices.
 Coordinate with other Local Government agencies in matters of Public health and safety
concerns.
Employment History______________________________________________________________________
STERIS APPLIED STERILIZATION TECHNOLOGIES – South Plainfield, NJ
Quality Systems Regulatory Compliance Technician II, 2011 to Present
H & R BLOCK, INC – South Plainfield, NJ, Plainfield, NJ, Scotch Plains, NJ
Client Services Professional, 2008 to 2015
CITY OF PLAINFIELD DIVISON OF INSPECTIONS – Plainfield, NJ
Code Enforcement Officer, 2005 to 2007
AMERICAN REDCROSS TISSUE SERVICES – Eatontown, NJ
Quality Control Coordinator, 2003 to 2005
CELGENE CORPORATION – Warren, NJ
Team Leader Customer Service TAAP Program, 2001 to 2003
AMERSHAM BIOSCIENCES – Piscataway, NJ
Customer Service Coordinator, 2000 to 2001
Education _______________________________________________________________________________
RUTGERS, THE STATE UNIVERSITY OF NEW JERSEY – New Brunswick, NJ
SCHOOL OF MANAGEMENT & LABOR RELATIONS
Bachelor of Science Degree, 2017 GPA: 3.5/4.0
ASQ-Certified Quality Auditor, Recertification 2017