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Manager Quality Assurance

Location:
United States
Posted:
June 20, 2012

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Resume:

IRENE BANAS

**W*** McCarron RoadGlen Ellyn, IL **137 idbanas@gmail.com630-890-3767

Program Manager highly experienced at identifying early stage development projects, conducting business valuations, assessing risks and conducting quality reviews, and managing programs that impact all levels within an organization. Exceptional communicator and independent thinker that can disseminate, analyze, and summarize complex information and influence leadership decisions.

B.S. – University of Michigan, MBA - Operations Management, Benedictine University, Lisle, IL

Board Member: University of Illinois Extension Council (2010 - 2011), Illinois Petroleum Resources Board (1999 – 2002).

AREAS OF EXPERTISE

COMMERCIALIZATION OF TECHNOLOGIES GOVERNMENT/REGULATORY/COMPLIANCE

Product Opportunities Policy Design/ Corporate and Government

Technology Performance Evaluations Reporting, Record Keeping, Waiver/ Exemptions, Audits, Risk Assessments

Business Case Development Avoid/Reduce Fines

Proposal/Grant Development Environmental/Operational Safety

PROFESSIONAL EXPERIENCE

Beutlich Pharmaceutical LLC - Management Consultant Present

Developed FDA responses to 483’s, labeling changes, registration templates, and streamlined regulatory management process.

Argonne National Laboratory - Regulatory Compliance Manager 2009 – 2011

Managed the regulatory program at the Lab. Assessed, implemented, and managed all regulatory requirements and technical standards that impact Laboratory operations. No Notices of Violations were issued during my tenure.

Monitored legislative and regulatory activity and provided strategic regulatory guidance to senior management. Communicated new requirements and changes to existing requirements with Division Directors and represented the Lab to government regulatory officials.

Developed and prioritized risks, completed quarterly quality assurance assessments, worked with department managers and government regulators to develop implementation plans, and authored internal policies and procedures for regulatory compliance.

Developed a web-based regulatory management tracking system, which I integrated with their existing Laboratory Management System (ISO 9001 and 14001 certified).

Gas Technology Institute - Senior Advisor 2009

Advised senior management on existing and anticipated regulations and energy policy.

Developed the business and commercialization section of three (3) government funded proposals. Proposals won $25 million in funding for GTI.

British Petroleum - Regulatory Compliance and Advocacy Manager 2006-2009

Provided regulatory services that helped BP comply with federal, state, and local regulations for all operations east of the Rockies. No Notices of Violations were issued under my tenure.

Communicated and made presentations to impacted departments on new and changes to existing regulations.

Provided oral and written comments to regulatory agencies on draft regulations.

Conducted root cause analysis on noncompliant issues, developed and monitored cost effective mitigation plans.

Annually registered all US BP operating facilities.

Developed and maintained an internal web-based regulatory document suppository of BP regulatory documents. Developed and maintained a regulatory management internal website.

Worked with government regulators during 2007 & 2008 hurricane season and 2008 power outage at BP’s Texas City (TC) refinery that avoided supply disruptions at retail sites, saving revenue and maintaining critical fuel supplies.

Participated in audits of BP refineries with government officials and refinery managers. Coordinated and helped with the implementation of audit findings with refinery managers. Submitted required documentation and avoided Notices of Violations.

Worked with the trading department to establish a methodology to sell energy credits (Renewable Identification Numbers, RINs in the RFS). BP RIN trading program was the most advanced program at the time and generated in excess of $1.5 million (2007 & 2008).

Argonne National Laboratory – Analyst 2005 –2006

One year appointment to conduct site assessment visits and develop 500 reports for the White House. Conducted site assessment visits with Homeland Security and government officials at various U.S. facilities to determine infrastructure vulnerabilities in the event of natural disasters or terrorist threats. Developed options to better secure facilities against such threats.

University of Illinois at Chicago - Analyst 1995 –2005

Managed contract between University and the Gas Technology Institute (GTI), client, including personnel, budget, scope and deliverables. Original contract was one-year, I extended and increased it for ten years.

Conducted techno-economic studies on GTI developed products. Developed methodologies, which quantified key performance measures using cost/benefit and NPV analysis. Third party auditor found work to be highly accurate and representative. Results published in annual report for GTI Board.

Conducted business development activities for new products that included global marketing strategies, product demand forecasts, competitive intelligence analysis, financial feasibility analysis, pricing strategies, and emerging market analysis.

Developed proposals for state and federal funding, applied for grants, that included cost benefit analysis, ROI, deployment/commercialization/marketing plans, NEPA, environmental impact analysis, and investment/funding options.

Won contract with the State of Illinois to develop two Requests for Proposals (RFP’s) for natural gas and electricity. Aided in vendor selection and contract negotiations.



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