BRETTINA TARASUT-VOICU 626-***-****

ad2n9s@r.postjobfree.com

SUMMARY

Over 10 years’ experience in Quality Assurance for medical device manufacturers, nutraceuticals and biologic research

* ***** ***** level regulatory support EU, MDR, GUDID.

Experience in the medical devices industry with Class II implantable devices, Class I & II reusable devices, IVD devices. Competencies include regulatory compliance standards, quality implementation audits ISO13485:2016 and MDSAP, CAPA Process Analysis, knowledge of 21 CFR 820 QSR, ISO 13485, ISO 9001, ISO11137, ISO11737, ISO10993, ISO14644, Document control processes, Cleanroom management, bioburden and sterility qualifications and compliance.

Pursuing Master in Biotechnology Regulatory Affairs- University Maryland University College

Self-motivated with significant positions ranging from associate to supervisory-level experience and relevant technical

education supporting Quality Assurance, manufacturing, R&D. Organized and detail-oriented individual who

exemplifies professionalism, and an ability to manage multiple projects and tasks at any given moment.

EXPERIENCE

Microvention-Terumo

Aliso Viejo, CA

(2019 to Present)

Senior Analyst, Quality Systems

Active Support to Quality Systems to ensure compliance with global regulatory requirements, for 21 CR 820, ISO13485, ISO14971, EMDR/MDD, MDSAP and CMD/CAS regulations to ensure Quality Systems are used effectively to support company quality policy and objectives. prepares and analyses reports/metrics, update procedures and participates/facilitates Quality Systems related discussions for the maintenance and improvement of Quality Systems.

•CAPA System- CAPA, support non-conformance activities, monitor effectiveness of corrective/preventive actions, process improvements and failure analysis – support, track and assist with root-cause, investigation, identify failure causes, and corrective actions.

•External/Internal Audits- Supports external and internal auditing activities related to CAPA and FCA, internal audits conducted by Microvention Associates or consultants. Assists in preparation activities for third party audits including FDA, Notified Body, corporate and international regulatory authorities audits. .

•Quality System Metrics - Assists in preparation and improvement of quality system metrics, and trends to drive improvement on overall Quality System program. Evaluates and analyzes the efforts in organizing documenting and making recommendations to management on quality improvement process. Escalates critical issues that warrant further actions.

•Quality System Training – develops and conducts quality related training, including best practices, and quality improvement processes.

•Quality System Improvements – Partners with process owners in the planning and implementation of quality improvement initiatives.

Nuvasive Specialized Orthopedics, Aliso Viejo, CA

(2017 to 2019)

Senior Quality Assurance Specialist

Support the organization in monitoring compliance and ensuring continued effectiveness of the QMS according to GMP,

and QSR requirements, following ISO13485:2016 and MDSAP, MDD requirements for the development and

manufacturing of Class 1, Class II orthopedic implants for limb lengthening.

•CAPA System: CAPA, SCAR and NCMR support non-conformance activities, monitor effectiveness of corrective/preventive actions, process improvements, trending, metrics.

• Failure analysis – support, track and conduct root-cause investigation, identify failure causes, and corrective actions

•Remediation and tracking of actions items from management review, audits, CAPAs and NCMRs with cross functional teams from Regulatory, R&D and Manufacturing.

•Bioburden and sterility qualification and maintenance: manage quarterly dose audits, trends, annual assessment

•Environmental Monitoring and Cleanroom compliance: manager EM quarterly program,

• Supplier Management –ensure quality of purchased component via NCMR, SCARs support for supplier performance trending

• Audits – Support quarterly internal audits and annual external audits to ensure compliance with requirements, audit schedule preparation, quality review of procedures, protocols, risk assessments.

• Compliance - provide timely response and implement corrective actions to address internal/external audit findings

•Management Review -Support organization for compliance to QSR requirements

•Change Control - Review, provide quality insight and support change control process for procedures

•Training - Manage training program, metrics, conduct and/or support quality training including, but not limited to: induction/orientation, ongoing quality training. CAPA and NCMR process

•Regulatory - GUDID registrations for new products and components, support level for Regulatory

DaVinci Biosciences,

Yorba Linda, CA

(2016 to 2017)

Quality Assurance and Regulatory Compliance Specialist

Support Regulatory and Quality Systems Manager with all aspects of quality assurance and compliance in the

development and manufacture of biologics for stem cell research.

•Change Control -Manage document control, perform routine procedure review and creation, support changes to existing product mfg process ensure adherence to ISO 9001 compliance.

•Compliance - Support review and approval of quality control operations and laboratory records to ensure adherence to ISO 9001 standard and compliance with applicable regulations – particularly 21 CFR 1271, cGTP, GDP, and GMP for both 361 and 351 HCTPs.

•Supplier Management - manage supplier quality/performance, evaluate, and qualify new suppliers and materials

•Non-conformance Systems - Assist with managing/recording customer complaints, CAPA, Deviations, and implementing appropriate corrective and preventive actions.

•Internal /External Audits – preparation, scheduling, investigating to ensure compliance with requirements, audit schedule preparation, quality review of procedures, protocols

•Clinical Trial - drafting data capture tools and writing reports in support of regulatory submissions.

•Environmental Monitoring Program - qualified for ISO Level 5, 7 and 8 cleanroom, maintain and microbiological monitoring program established.

Bio-Rad Laboratories,

Irvine, CA

(2011 to 2016)

QA Specialist II

Technical Project Quality Specialist to manufacturing for support of Quality Control kits and OEM Manufacturing.

•Change Control: support document control in creation and revision of procedures to support manufacturing, marketing and Quality Control.

•Design transfer - Quality SME for transfer of new and extension products from R&D and contract manufacturers.

•Quality Control - Technical review of new and revised manufacturing and testing specifications, LIMS database.

•Regulatory - support and track status of new and revised label, IFU and eIFU for compliance to regulatory requirements.

•Non-conformance reporting - support MRB to investigate and disposition in-house product failures

•CAPA system –support non-conformance activities and investigations

• Manufacturing–Support and maintain Mfg & quality specifications and procedures, technical batch record review and raw materials specifications for compliance

•Technical review of material safety data sheets for compliance.

•Assist with several document and project audits for ongoing product design.

Focus Diagnostics, Cypress, CA

(2005 to 2010)

Quality Assurance Supervisor

Support the development and production of Focus’ IVD products, both molecular and immuno-diagnostics, for the detection of human infectious diseases such as the Flu/H1N1 virus, West Nile, Dengue, and MRSA, supporting compliance to applicable regulations: FDA, ISO, IVDD, and CMD/CAS

Demonstrated history of successful production quality assurance and process optimization execution, while delivering high-quality guidance and support to senior management and facilitating effective cross-functional team operations

• Supervise Quality Assurance Inspectors in receiving inspection, in-process inspection, finished product testing/inspection

•New product development – participate in core team as Quality representative in a structured PDP process

•Manufacturing – support manufacturing, resolutions of conflicting changes, and working closely with owners to assure all needs are met utilizing Master Control and Pilgrim

• Non-conformance reporting - lead MRB to investigate and disposition in-house product failures

• Design change control – Quality representative for technical review of the product and process change process to ensure compliance to regulations

• Validation – support technical review of validation activities for new and modified products and processes

• Supplier management – manage supplier quality/performance, evaluate, audit, and qualify new supplier

• CAPA system –support CAPA activities, monitor effectiveness of corrective/preventive actions

•Training – support new employee orientation and internal training on GMP, GLP and GDP and use of

documentation control systems and process

• Internal audits/External Audit - conduct routine audits, support External audits preparation, back room support.

• Complaints - support review of investigations to confirm complaints & failures, corrective/preventive actions

Nellson Nutraceuticals, Irwindale, CA

(2002 to 2003)

Quality Assurance Documentation Supervisor

Responsible for improving the quality of Nellson’s line of nutritional bars and supplemental drinks for support of weight management and health.

• Supervise Quality Control Inspectors and Microbiology Laboratory in receiving inspection, in-process inspection, incoming and finished product testing and releases.

• Non-conformance reporting - support MRB to investigate and disposition in-house product failures

• Internal audits - conduct routine audits per to ensure compliance

Production line support, resolve technical issues, investigate non-conformances, implement corrective actions

• Establish and maintain quality specifications and procedures, train and qualify production personnel

•Established quality documentation process for consistency and support of manufacturing

Metric established quarterly trend reports : Training logs, material turnaround, analyze Quality Lab results

•Change Control -Manage document control, perform routine procedure review and creation, support changes to existing ingredients and finished product specification for technical review of chemical and microbial testing protocols.

•Training - General Manufacturing Practices and HACCP implementation and the proper use, safety

and maintenance of laboratory equipment

Other work history and experience

2003-2004 Sylvan Learning Center, Glendora, CA-Tutor Math and Reading

2003 Glendora Unified School District, Hacienda Heights Unified School District-Substitute Teacher

2003 CSU Pomona Upward Bound Program, Pomona, CA-teach summer program- Science

Intern, 1999 - 2000 California State Department of Health FDB, Ontario, CA

Field operations of the Food and Drug Branch. Assisted in special projects, selected inspections and investigative activities related to the Enforcement of California Food, Pharmaceuticals, Medical Devices, Cosmetics and Hazardous substances laws.

Gaps in history, Returned to school:

2003-2004, 2010 CSU Pomona- Credential Program, Post graduate

2010- Mt Sac, Walnut, CA Financial Accounting and Bookkeeping

2010 -2011 temporary work assignments: tutor and substitute teach.

TECHNICAL SKILLS

Knowledge of Lean Manufacturing concepts

Working knowledge of laboratory and cleanroom technologies: sterilization, autoclaves, Airy Technology particle counter and EMD Air sampler, lyophilizer, PCR, western blots, pH, water analysis, gas chromatography, pipettors, moisture analysis, Brix, media prep.

Knowledge of QMS, Mastercontrol, LIMS, ERP systems: SAP, Baan, AS400,Pilgrim, QAD

Proficient with Microsoft Office: Word, Excel, PowerPoint, Access, and Project, VISIO, Peachtree, Quickbooks

EDUCATION

B.S., Microbiology, Med Tech, Chemistry Minor, California State University, Pomona, 2001

M.S., Biotechnology Regulatory Affairs, University of Maryland, University College, In process

2002-2003 California State University Pomona, Pomona, CA-Post Graduate- Credential Program Biology( incomplete) returned in 2003 and 2010

2008 Internal Audit certification through Focus Diagnostics, Inc.

2009 ASQ Orange County, CA - Six Sigma Black Belt course( no exam), Green Belt Project participant for Focus Diagnostics Quality metric improvement

2010- Mt Sac, Walnut, CA started Accounting program courses

REFERENCES

Available upon request

Contact this candidate