GUSTAVO ARTURO AGURTO

**** ****** ******

East Chicago, IN 46312

219-***-****

Email: ac155x@r.postjobfree.com

PROGRAM DIRECTOR..OPERATIONS MANAGER..

A diligent, accomplished professional with over 20 years’ comprehensive experience in managing compliance and quality concerns for health care service delivery and manufacturing seeks to apply background, education and abilities toward the growth of a progressive organization. PROFILE

FIELD EXPERTISE: Extensive background in quality control. Proven record of accuracy and efficiency in facilitating operations while adhering to all regulatory standards (FDA, CDC). Broad understanding of cross-functional roles, including counseling, data control and special donations. ORGANIZATION AND PLANNING: Manage multiple priorities simultaneously, attending to details and adhering to standards. Make confident, informed decisions in demanding situations. Identify potential concerns, implement strategies and monitor progress in addressing them. INTERPERSONAL RELATIONS: Interact with personnel at all levels, eliciting input and providing consultation to deliver common results. Prepare and deliver clear, audience-specific presentations, explaining difficult concepts in understandable terms. Assume leadership in team settings. ADDITIONAL SKILLS: Fluency in five languages – French, German, Italian, Spanish and English. Experienced in writing standard operating procedures; delivered multiple presentations on good manufacturing and laboratory practices. Medical Doctor with ongoing commitment to learning. PROFESSIONAL EXPERIENCE

LIFESOURCE – Glenview, Illinois 2000 to Present

Donor Relations Specialist (2004-Present)

Ensure adherence to governmental and organizational regulations for leading Chicago-area blood bank. Review donor applications, verifying information to ensure accuracy and readiness for internal audits. Interface with directors of Labeling, Manufacturing, Production, Testing and Donor Counseling departments to facilitate timely release of blood. Prepare and compile documents for approval by quality department (Possible Duplicate Donors, Prohibiting Factor). Provide explanatory justifications for acceptance or rejection. Confer with personnel from FDA, CDC and ABB. Coordinate shipments to domestic and international destinations. Maintain current awareness of eligibility criteria, operating procedures and regulatory developments.

Received internal letter of commendation citing work ethic, effectiveness in role and dedication toward meeting organizational needs.

Assumed a range of added responsibilities following departure of former supervisor in 2015, including quality indicators, department scheduling and interaction with parent company.

Maintain exceptional record of zero department errors or issues requiring government involvement. Auditor (2000-2004)

Observed multiple standard operating procedural parameters for analysis of donor applications to determine acceptance or rejection of blood supply. Contacted branches and mobile locations to inquire about any potential issues. Reviewed local and federal guidelines to establish any risks and determine appropriate course of action, such as destruction or quarantine for further investigation. Implemented measures to cease donation process in cases adversely affecting donors. Gathered and prepared daily activity reports for Manager of Donor Relations. Completed continued training in policy additions or changes.

Worked with Vice President of Quality in extensive project to establish identity, recognize duplicates and merge data for over 20,000 donors.

Managed four times standard donation volume following September 11, 2001 attacks, working considerable overtime seven days per week to ensure prompt release.

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PROFESSIONAL EXPERIENCE (Cont.)

PERSONAL LEAVE 1998 to 1999

Attended to ailing mother in South America

G.D. SEARLE – Skokie, Illinois 1984 to 1998

Director of Regulatory Affairs (1995-1998)

Coordinated approval process through FDA in new drug investigations for then third-largest pharmaceutical manufacturer nationally. Supervised 85 employees, including, supervisory team and support staff. Submitted new drug applications. Oversaw requested studies (e.g., toxicology, allergy) to clear drugs and define appropriate usage. Coordinated with Vice Presidents of Quality and Regulatory Compliance. Monitored inventory of controlled substances, ensuring accuracy for audits. Attended global meetings to maintain current product and regulatory knowledge.

Established highly favorable relationship with FDA, characterized by no incidents and monthly contact regarding policy changes.

Maintained perfect record of no recalls during directorship, protecting company from any potential revenue loss or negative publicity.

Manager of Quality Control (1990-1995)

Developed and trained staff in standard operating procedures, detailing benchmarks, timelines and rationale. Conducted internal inspections for 15 departments. Interfaced regularly with FDA officials and hosted unannounced audits. Identified and documented any operational discrepancies. Represented company at industry conferences; delivered presentations on best practices internationally. Continually pursued training in quality assurance.

Ensured avoidance of any incidents through fostering knowledgeable staff and closely monitoring operations.

Participated in 15-year process to introduce aspertame sugar alternative to U.S. market. Manager of Regulatory Compliance (1984-1990)

Coordinated response to any potential concerns of government or public, preparing comprehensive documentation to bolster company position. Established efficacy of product lines, demonstrating absence of any toxicity and minimal side effects. Worked closely with Director of Regulatory Affairs.

Recognized consistently in annual evaluations for exceptional record of no incidents. EDUCATION

UNIVERSITY OF LAUSANNE – Lausanne, Switzerland

Medical Doctor, 1982

UNIVERSITY OF KENTUCKY,- Lexington, Kentucky

English Program for Foreign Graduate Students, 1983 DEPAUL UNIVERSITY-Chicago, Illinois 1983 to 1984

Completed courses in Computer Science

UNIVERSITY OF WISCONSIN – Madison, Wisconsin

Continued course work while at G.D. Searle, including Pharmacology and Statistics and Stability PROFESSIONAL DEVELOPMENT AND INVOLVEMENT

PARTICIPATED IN NUMEROUS SEMINARS IN QUALITY CONTROL, QUALITY ASSURANCE AND FDA- RELATED ISSUES, AT GLOBAL LOCATIONS (BRAZIL, MEXICO, ENGLAND) CERTIFIED NATIONAL QUALITY AUDITOR, 1986 to Present. CONSIDERABLE VOLUNTEER WORK WITH ELDERLY AND HOMELESS INDIVIDUALS

-Professional references available upon request-