Darrell L

Mary Lopes, CQIA

6412 High Brook Drive

Fort Worth, TX 76132

(817) 228-5945 E- Mail: marylopes63@hotmail.com

SUMMARY OF QUALIFICATIONS

Certified Quality Improvement Associate (CQIA) with four years experience in pharmaceutical operations, current Good Manufacturing Practices (cGMP), quality inspections, document control, and labeling approval. Demonstrated ability to work as a team player with other departments to meet regulatory compliance for US and Canadian inspectors.

CAREER EXPERIENCE

Virbac Corporation, Fort Worth, TX 2003 – Present

Quality Assurance Auditor II (2007 – Present); Quality Assurance Auditor I (2003 – 2007)

· Issue manufacturing and packaging batch records to production, audit completed batch records and test results, visually inspect finished products for conformance to specifications, and release finished products meeting all release specifications in accordance with current Good Manufacturing Practices (cGMP) as described in 21 CFR § 211.

· Evaluate Certificates of Analysis and stability testing results, and initiate investigations in response to out of specification (OOS) results.

· Obtain input from Research & Development and Operations departments while implementing corrective and preventative actions (CAPA).

· Review, approve, and release labeling for EPA and FDA regulated products.

· Maintain hard copy files, databases, and online PDF files of controlled documents including product formulations, Standard Operating Procedures (SOP), labeling and/or graphic art, master manufacturing and packaging batch records, completed batch records, historical product files, and corporate forms.

· Control inventory virtually in Oracle system and physically by conducting inventory cycle counts.

· Coordinate release of regulated drug products with foreign affiliate in compliance with Canadian regulations.

· Provide support during audits performed by regulatory agencies (e.g. FDA, Health Canada, and EPA).

Westcliff United Methodist, Fort Worth TX 2002 – 2003

Preschool Substitute Teacher

· Supervised children age 18 months to 4 years.

· Designed daily activities and age-appropriate craft projects.

· Coordinated daily planning with other teachers and school administrator.

Sycamore Elementary, Fort Worth TX 2001 – 2002

Lunchroom Monitor

· Supervised elementary school cafeteria activities.

· Maintained order and discipline among students.