SR. Quality Assurance Specialist

Lisa Davis

Telephone: 317-***-****

e-mail: by5t1e@r.postjobfree.com

QUALITY ASSURANCE PROFESSIONAL

Quality assurance professional with 20 years of quality experience in a major multinational US pharmaceutical company.

QUALIFICATIONS

• Quality Assurance Professional with a proven history of successful management of quality systems

• Results oriented leader having a demonstrated record of career progression by building expertise in the Quality and Manufacturing fields.

• Skilled in interpreting SOPs for compliance with FDA regulations

• Demonstrated strong leadership, excellent communication skills, competent, strong team player, attention to detail, dutiful respect for compliance in all regulated environments, as well as supervisory skills including scheduling, training, and other administrative tasks.

KEY ACCOMPLISHMENTS

• Key contributor of the departmental safety team that implemented solutions to reduce ergonomic injuries and unsafe practices on manufacture floor.

• Presented solutions to departmental productivity team. The solutions were implemented and reduced cycle time and improved productivity.

• Serve as a technical resource and trainer for all new employees to perform area line clearances and statistical in process checks.

• Provided quality feedback on over 100 SOP’s that improved SOP contents for functionality.

PROFESSIONAL EXPERIENCE

04/91-Present: Eli Lilly and Company, Indianapolis, Indiana

Quality Assurance Specialist

• Review all batch record documentation/Disposition

• Writing and reviewing SOP’s

• Train new employees

• Investigate and write customer complaints

• Participate in Internal and External audits

• Release incoming bulk material

• Stability Program

• Logbook review

• Write Deviations and change controls

• Six Sigma Projects

• Quality Systems

• Controlled Substance Certified

• Perform Sampling for incoming bulk

• Protocol Review

Quality Control Document Coordinator

• Responsible for scanning in batch records

• Maintained security for cGMP Library

• Retrieved all Clinical Trail Data

• Trained and mentor new employees

• Implemented new tracking tools

• Responsible for testing software

• Prepared all IQ, PQE, IQOQ documentation

• Maintained Quality Agreements

• Responsible for gathering documents for audits

Aseptic Operator - Leader

• Assembly line leader for Insulin fill finish line

• Performed Parenteral Dose Control for quality filling

• Perform Real Time Review for documentation compliance

• Trained associates in aseptic processing technique and proper aseptic gowning procedures

Manufacturing Operator - Leader

• Responsible for managing the day to day operations of a team of technicians to maintain a workable environment

• Set-up equipment for use in manufacturing of raw materials

• Monitored raw material production for processing

EDUCATION

• Indiana University – Purdue University of Indianapolis

• Associates Degree in General Studies with a minor in Sociology - 2008

• GPA – 3.1/4.0

• Courses for personal development

• Indiana State University – Algebra, Anatomy, Biology

• Ivy Tech - Anatomy and Physiology Class

REFERENCES

Available upon request

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