Quality Assurance Project

ERIC EVENSON

**** **** ***** *****-**********, Iowa 52241 563-***-****(H)

319-***-****(W)

Dynamic, solutions oriented project and facility management professional

with valuable quality, technical and administrative experience

demonstrating respect for everyone. Working in the steel, pharmaceutical

and facility management has allowed me to gain extensive experience in the

following areas:

> Standard Operating Procedures (Medical Equipment (Submit

Bid Requests (Facility Management

> Customer Complaints (Audits

(Validation (Qualifications

> Preventative Maintenance ( GMP-GLP Practices

(Manufacturing Equipment (Calibrations

> Schedule Management (Budget Monitoring (Environmental

Monitoring ( Cost Estimates

> Project Management (Laboratory Equipment

(Preventative Maintenance (OSHA

PROFESSIONAL EXPERIENCE

4/2010-Present University of Iowa- Finance and

Operation Iowa City, IA

Project Assistant-Facility and Project Management

. Schedule and coordinate meetings for University design projects for

the Project Management Team.

. Work closely with Project Managers to execute plans on planning,

design and construction on projects up too 200M.

. Provide project management support over the entire project to the

Project Managers and Construction Managers.

. Create Professional Service Agreements and Professional Service

Agreement Amendment and follow up accordingly.

. Prepare and distribute plan holder lists to printing contractor and

follow up for accurate distribution.

. Communicate and establish good business relationships with Consultants

and Contractors providing services.

. Advertise bids on the internet and local news publications. Review

bidding documents for accuracy.

. Assist with project planning and timeline and coordinate with all

parties involved, communicate and follow up.

. Assist with presentation materials and video conferencing as needed. .

. Work closely with Risk Management to execute projects as required

especially flood related projects.

. Attend meetings as requested and provide critical feedback for

department improvements.

. Develop project plans, monitor budgets closely and make sure projects

flow in the approval process and follow up as needed.

2004 - 2010 University of Iowa Pharmaceuticals, College of

Pharmacy Iowa City, IA

Engineer

1. Involved in all equipment purchases, modification to equipment and

installations of new or existing equipment. .

2. Develop customer and supplier relationships for equipment, consumables

and calibration services.

3. Work with departments to review future needs for equipment and find

cost effective suppliers for equipment.

4. Submit bids for equipment, services and evaluate and select suppliers.

5. Complete project management for the entire life cycle of the project.

6. Analyze, review, and re-negotiate current service contacts and future

contract proposals.

7. Submit single source justifications for one source vendors supplying

the equipment or service.

8. Execute qualifications, and calibrations of all quality control

laboratory equipment and manufacturing equipment.

9. Write or update standard operating procedures for all processes with

cGMP, GLP and OSHA standards.

10. Assist with departmental, contracting clients and FDA audits providing

critical information.

11. Perform or schedule preventive maintenance on facilities, equipment or

complex laboratory equipment and review certifications.

12. Monitor and report accurately on equipment, calibration,

qualifications and project status.

13. Work independently, manage multiple assignments, problems solve and

implement corrective action.

14. Communicate effectively with all departments and external sources.

2002-2004 University of Iowa Pharmaceuticals, College of

Pharmacy Iowa City, IA

Research Assistant/Quality Assurance Specialist

. Batch record review for incomplete or inaccurate information and

implement corrective action.

. Batch record investigations and deviations.

. Review daily environmental data from clean room monitoring from

previous production runs.

. Audit chemical/raw material inventory used in the pharmaceutical

production.

. Work with contracting clients on designs and specification for

blinded/double blinded as well as randomized label studies.

. Find cost effective supplies who can meet deadlines.

. Assist in the calibration and validation of numerous pieces of

pharmaceutical processing equipment and document deviations or failing

conditions for corrective action.

. Supervise Lab Assistants in the Quality Assurance area.

. Assist with departmental, external, contracting clients and FDA

audits.

1996 - 2001 University of Iowa Pharmaceuticals, College of

Pharmacy Iowa City, IA

Pharmaceutical Manufacturing Technician/Supervisor

. Interview, hire, supervise and manage 2 Pharmaceutical Manufacturing

Technicians and up to 12 Lab Assistants.

. Maintain master batch record files for University Hospitals and

Clinics.

. Coordinate the inspection, labeling, and packaging of all UIP

Pharmaceutical Products including controlled substances class I-IV

following departmental, cGMP and Code of Federal Regulations.

. Prepare labels using Auto Cad Tattoo ID labeling software and multiple

Zebra printers.

. Work with contracting clients for labels that cannot be made in house.

Find suppliers that are cost effective to clients' needs and can meet

deadlines

. Maintain Paradox database files for all University Hospital products

and prepare monthly and yearly reports.

. Prepare and distribute weekly production schedules for the University

Hospitals to all departments.

. Release all products upon verification from Quality Control,

Production, Quality Assurance

. Destruction and documentation of all rejected products following

University, State and Federal hazardous waste guidelines.

. Work with the QA Manager for new equipment, upgrades or other

departmental needs.

. Order and maintain packaging, media and labeling supplies in a cost-

effective manner.

1995 Letica Corporation

Muscatine, IA

Quality Control Manager/Supervisor

1989-1994 Cargill Inc., North Star Steel Company

Wilton, IA

Production Supervisor-Finished Goods

1983 - 1988 Cargill Inc., North Star Steel Company

Wilton, IA

Physical Testing Lab Technician

ADDITIONAL TRAINING (Training certificates are available upon request)

. Iowa Quality Systems-SPC 1 and SPC 2.

. Phillip Crosby-QUALITY AWARNESS EXPERIENCE

. SPC-Follow up workshop for SPC 1 and SPC 2.

. International Loss Control Institute-Modern Safety and Loss Control

Management (twice)

. Agilent Technologies-Troubleshooting and Maintenance

. Conducting Batch Record Reviews and Investigations.

. Good Manufacturing and Laboratory Practices

. Taking the mystery out of HPLC.

. Mastering your performance as a Quality Assurance Professional.

. Implementing Good Documentation Practices

EDUCATION

. Bachelors in Business Administration/Management, Iowa Wesleyan College

Mount Pleasant, IA

. Associate Arts Degree-Business, Muscatine Community College

Muscatine, IA

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