Romina Love

***** ****** *. ***, ******* Texas **044

Mobile: 713-257-3803Email:acz43q@r.postjobfree.com:acz43q@r.postjobfree.com

EMPLOYMENT HISTORY:

Steris - NOVO Health (Formerly Synergy Health Services) Houston, Texas

Quality Assurance Manager (Class II Medical Device Manufacturer) July 2012 – April 21, 2017

Demonstrated experience with 21 CFR Part 211, 803, 820, 806 and ISO 9001:2008 and ISO 13485 and AAMI Standards. Responsible for ensuring compliance of reprocessing medical device (Instrumentation and Textile) products, processes, and quality systems to relevant GMP Standards, FDA Regulations, AAMI, JACHO.

Management Representative of Quality Systems responsible for leading FDA inspections and customer audits.

Performed final quality assurance review and release of all products manufactured, assembled, and/or distributed.

Ensured FDA 21 CFR 820 requirements were implemented and maintained related to medical device steam sterilization reprocessing.

Monitored compliance with the quality assurance program established by the company to meet FDA, ISO, AAMI and other applicable regulatory guidelines.

Maintained product complaint system (Synergy Trak and CQMS). Responsible for researching complaints, developing a corrective action plan in conjunction with facility management, implementing the plan and communicating corrective action responses to customers. Responsible for the initial investigation and evaluation of potential reporting under the FDA Medical Device Reporting regulations.

Maintained accurate records of all quality programs established by the company, FDA or other regulatory body.

Managed documentation and investigation of process and product non-conformance . Ensured that appropriate corrective measures were implemented, monitored and that quarantined products were appropriately discarded.

Managed the electronic Nonconformance / Deviation and CAPA systems, with supporting documentation (Synergy Trak and CQMS / CATSweb).

Managed Change Control program. Interfaced with engineering for quality aspects of process or equipment changes.

Trained new hire and conducted annual training: Quality Systems, OSHA, GMP, Blood Borne Pathogen and SOPs.

Maintained the facility internal audit program and performed periodic quality systems audits with audit reports.

Prepared analysis reports as required by SVP Process Engineering & RA/QA Director.

Provided support to the Sales Team on Customer Issue Resolutions, Product Reviews and Quality Metrics (BRs).

Managed supplier sub-recalls, product returns and certificate of conformance approvals.

Responsible for product removal /quarantine and customer complaint notifications.

Managed and performed environmental monitoring testing and trend analysis reporting.

Hosted the material review board, quality review and management review meetings.

Managed the Facility level document control system, including document issuance, retirement and maintenance of the document history files in accordance with cGMP requirements (SOPs, Forms, Technical Information Sheets, Quality Manual, FDA Binder and Validations reports).

Conducted in-process inspection and audits of raw materials, final product release and incoming finish goods.

Managed Quality Assurance Technicians overall performance.

Reviewed and approved process and equipment validation reports.

Novum Pharmaceuticals, Houston, Texas

Senior Quality Assurance Specialist (Biotechnology / Pharmaceuticals Industry) August 2011 – June 2012

Responsible for reviewing Investigational Drug study documentation to ensure compliance to Standard Operating Procedures, Client and Regulatory agency requirements.

Reviewed study documentation for compliance to specific protocol requirements.

Conducted internal audits to assure compliance to Study Protocol. Author, review and approve Standard Operating Procedures (SOPs) for new processes or regulatory requirements.

Conducted batch documentation audits for multiple on-going Investigational Study (Drug) Protocols.

Conducted annual review of existing procedures providing process improvement recommendations.

Monitored and recorded study participate dosage and vitals.

Managed the document control system, including document issuance, retirement and maintenance of the Facility document history files in accordance with cGMP requirements (SOPs, Forms, Protocols, Quality Manual and Validations reports).

Gulf Coast Regional Blood Bank, Houston, Texas

Quality Assurance and Training Manager (Biotechnology / Blood Banking Industry) June 1998– Dec 2010

Demonstrated experience with 21 CFR Part 211 and 600, American Association of Blood Banking, ISO 9001, JACHO and DHS. Responsible for ensuring FDA, State and industry compliance was maintained in all aspects of Blood Banking production and National Donor Testing.

Reviewed / approved process and equipment validation reports.

Management Representative of Quality Systems responsible for hosting FDA Inspections and Customer external audits, including preparation activities and remediation plans.

Oversight of failure and discrepancy investigations and documenting investigations on process deviations or equipment malfunctions.

Developed and provided oversight to identification and implementation of appropriate corrective actions and preventive actions.

Maintained electronic Quality Management Systems related to cGMP Training Records, Non-Conformance (NCR) reports and CAPA compliance (MasterControl, TrackWise).

Managed complaint report evaluations and communications, including initial complaint assessment of Medical Device Reportable (MUADE) incidents.

Managed quality system compliance auditing of both internal and external sites in Texas.

Developed and conducted OSHA, GMP, Quality System Regulation and 21 CFR Part 211 and Blood / Biologics In-Service training for all staff annually, post audits, and new staff on-boarding.

Prepared analysis reports and hosted Material Review Board, Quality Review and Management Review Meetings.

Established and maintained key relationships with Customers and business counterparts to provide excellent quality customer service.

Managed the document control system, including document issuance, retirement and maintenance of the Facility document history files in accordance with cGMP requirements (SOPs, Forms, Technical Information Sheets, Quality Manual and Validations reports).

Generated ad-hoc quality system reports and data to support TMC Hospital Affairs and the Medical Director.

Managed the change control and product deviations program.

EDUCATION:

University of Houston, Houston, Texas May 2003

Bachelor of Business Administration, Management

University of Houston, Houston, Texas May 2005

Bachelor of Science, Public Healthcare Administration

University of Phoenix, Houston, Texas Dec 2007

Master of Business Administration, Quality Management

Organizations:

ExCEL (Excellence Uniting Culture, Education and Leadership)

ASQ (American Society of Quality)

VOLUNTEER:

iMPACT (Volunteer Organization) March 2013 – Present

Kids’ Meals – Active participant in the on-going meal prep project for underprivileged children within inner Houston.

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