Quality Assurance Manager

Lorna González, MS, MT(ASCP)

*** ******** *****, ***** ******, Tennessee 37122

Home: 615-***-**** Mobile: 847-***-****

E-mail **************@*********.***

SUMMARY OF QUALIFICATIONS

Highly experienced Quality Assurance Professional with the following credentials:

• Proven skills in batch record review for lot release.

• Proficient in creating, developing and managing test protocols, quality control programs, trend analysis and auditing for compliance to FDA regulatory requirements.

• Proficient in authoring SOPs for quality operations.

• Former CQA (ASQ) Auditor.

• Proven skills in clinical and industrial microbiology.

• Experience managing direct (up to 5) and indirect (up to 25) reports.

• Fluent in Spanish.

EDUCATION

MS, Cellular and Molecular Biology, Eastern Michigan University

2nd BS, Medical Technology, Michigan State University

BS, Biology, University of Puerto Rico

PROFESSIONAL EXPERIENCE

QA/QC MANAGER, BERG PHARMA, Nashville, Tennessee Aug. 2011 – May 2012

• Manage and oversee the activities of a small team engage in establishing a QA department in a new and rapidly emerging company.

• Designated by upper-management as the Manager with Executive Responsibility to represent the Nashville facility in FDA audits.

• Introduce new technologies (i.e, EndoSafe PTS endotoxin testing) to enhance company capabilities. Such introduction resulted in annual savings of $60,000 of costs for tests outsourced.

• Because of the success obtained in the introduction of new technologies and my skills in Microbiology, was given the task of developing a Microbiology department to further bring in house Sterility testing for further company savings.

• Given the task of developing and establishing and Environmental Monitoring (EM) program for the cleanrooms being built for product manufacture.

• Wrote the Quality Manual to describe operations for Phase 1 manufactured products.

• Audit manufacturing operations for compliance to internal policies and federal regulations.

INDEPENDENT CONTRACTOR, Grayslake, IL 2009 – Jan. 2011

• As a Project Specialist at ABBOTT Laboratories, verify and perform data simulation studies for a product transfer project from operations in Puerto Rico to Lake County.

• As a QA Specialist at Nanosphere Inc., perform batch record review and release of intermediate and final products.

• As a Regulatory Affairs Specialist at BioForm Medical, Inc., obtained state licenses to sell product in the US; organized and compiled reports to prepare product submission to the FDA.

• As a Regulatory Specialist for Valent Biosciences, provided translation services and organized reports for regulatory submissions in Latin America.

• As a Contractor for Microsoft at Baxter in IL, facilitated translation and software validation for a product from the renal division to be launched in Spain, ensuring compliance to the requirements of 21CFR Part 11 and internal protocols.

CGMP FACILITY, UNIVERSITY OF CHICAGO, Chicago, IL 2004 – Oct. 2009

QA/QC Manager

• Managed clinical research groups in the Human Islet Transplantation and Cancer Vaccine production by overseeing trial execution, issuing batch records and performing final product release per SOP and IND requirements.

• Authored, developed, and implemented quality systems SOPs to comply with the Quality Systems Regulation in 21CFR 820 such as:

O Deviations System

O Corrective/Preventive Action System

O Good Documentation Practices O Change Control System

O Risk Management

O Investigations

• Performed review of batch records of manufactured products to ensure compliance to protocols and IND requirements.

• Wrote Quality Systems Manual for the cGMP facility, increasing awareness among research investigators of the environmental superiority of facility to manufacture products for clinical research.

• Became a Certified Quality Auditor by the American Society for Quality –CQA(ASQ)

PHARMACEUTICAL SYSTEMS, INC (PSI), Mundelein, IL 2003 –2004

Consultant and Quality Assurance Professional

Consultant for PSI providing consulting services for PSI clients on microbiology issues encountered in the pharmaceutical industry.

• Performed validation activities for Amgen in response to expansion and new construction. This resulted in the timely opening of the newly constructed facility.

• On-time delivery the training modules requested by Schering-Plough in response to Consent Decree demands by the FDA.

• Consulted in microbiology issues which included verifying against USP testing methods, ensuring GMP compliance as a result of a Consent Decree against Schering-Plough.

• Designed metrics using EXCEL statistical functions to track/trend deviations, identifying root causes for problems and presenting results to senior management for a depiction of areas for improvement.

ABBOTT LABORATORIES DIAGNOSTIC DIVISION, Libertyville, IL 2000 –2003

Manufacturing Supervisor, Compliance

Supervised, developed and evaluated the activities of one direct and 32 indirect reports. Reviewed and approved in CAPA NCRs (Non-Conformance Reports), tracking/trending NCRs, preparing reports using EXCEL statistical functions and graphics to identify areas for improvement.

• Effectively managed all departmental quality and compliance issues, reducing employee-related errors and bringing the Service Center into compliance with federal regulations.

• Responded to internal audit observations, decreasing audit observations by 70% in 2002.

• Reviewed and updated SOPs for clarity, accuracy and compliance, increasing the quality and user-friendliness of written instructions as well as compliance with regulations.

• Reviewed and approved all departmental Non-Conformance Reports (NCRs); prepared the reports resulting from internal audit observations.

Validation Scientist/Coordinator 2000 –2001

• Managed group of seven technical writers in Hepatitis/Retrovirus responsible for Validation Product Remediation (VPR) documents for audit by the FDA in response to the Consent Decree. Monitoring and reporting progress to upper management in the execution of such activities, achieving on-time delivery to the FDA.

3M HEALTH CARE/TERUMO CARDIOVASCULAR SYSTEMS, Ann Arbor, MI

1997-2000

Advanced Microbiologist

Co-managed and provided technical guidance to a six-person team engaged in microbiological quality issues encountered in the manufacture of medical devices.

• Developed and established in-house assays (LAL, Cytotoxicity) for manufactured devices, resulting in over $60,000/year in company savings.

• Performed Batch Record review, approval and/or rejection to investigate and resolve microbiological issues, ensuring product safety.

• Interpreted RODAC Bioburden and CLIMET Particulate test results of cleanroom operations.

• Developed, validated and implemented the Cytotoxicity Assay per USP<87>, BSI 5736 and ISO 10993-5, reducing costs of tests outsourced.

• Nominated for 3M’s Circle of Excellence award in 1998.

PRIOR EXPERIENCE

DIFCO LABORATORIES, Detroit, Michigan,

Quality Assurance Microbiologist

W.A. FOOTE Memorial Hospital & Garcia Clinical Laboratories, Jackson Michigan

Clinical Microbiologist

PROFESSIONAL DEVELOPMENT / CERTIFICATIONS / PROFESSIONAL AFFILIATIONS

Continuing Education in Clinical Trials Administration, Eastern Michigan University, Parke-Davis Pharmaceutical and Pharmacia-Upjohn

Medical Technologist (MT) Certification, American Society of Clinical Pathologists (ASCP)

Former Certified Quality Auditor (CQA), American Society for Quality (ASQ)

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