Quality Assurance Management

Maria L. Rossolino

* ******** ****** **, *********, N.Y. 10583

(C) 914-***-**** (W) 845-***-****

act3pw@r.postjobfree.com

EDUCATION

Fordham University, Bronx, N.Y.

B.A. Natural Sciences – 1990

PROFESSIONAL EXPERIENCE

Cardiovascular Research Foundation

Manager, Quality Assurance December 2009 - Present

Quality Program Management

•Implement and maintain the Cardiovascular Research Foundation’s quality program; promotes and facilitates continuous improvement (GLP/GCP).

•Develop and implement procedures for quality assurance and guides the development of Standard Operating Procedures.

•Identify and resolve quality issues.

•Ensure compliance with Good Laboratory Practices (GLP), Good Clinical Practices (GCP) and relevant regulatory requirements.

•Facilitate client/sponsor audits and regulatory inspections; leads tours, present requested documents and answer client questions (GLP/GCP).

•Keep up-to-date on information and technology affecting functional area(s) to increase innovation and ensure compliance.

Auditing/Inspecting

•Schedule and conduct QA audits for study procedures, data and reports (GLP/GCP).

•Review and approve equipment validation protocols and validation summary reports.

•Responsible for conducting facility (internal and external) inspections.

•Conduct project specific, system, and vendor supplier audits (GLP/GCP).

Document Review and Approval

•Review protocols and Standard Operating Procedures (SOPs) for compliance with principles of GLP/GCP.

•Write Quality Assurance SOPs.

•Review all SOPs for compliance with applicable regulations.

•Approve the completion of CAPAs.

Administrative

•Supervise Sr. QA Associate, Archivist and consultants.

•Maintain the facility Master Schedule.

•Provide reports of any deficiencies to Management and ensure resolution through CAPA system for continuous improvement (GLP/GCP).

•Verify to Management that facilities, equipment, personnel, procedures and policies are in conformance as with appropriate government regulations and industry standards.

Personnel Training

•Conduct training on regulatory requirements and quality initiatives (GLP/GCP).

Ciba Corporation, Tarrytown, N.Y.

Quality Assurance Specialist October 2006 – November 2009

Program Management

•Develop and implement, Quality Assurance program, which meets cGMP (current Good Manufacturing Practices) and GLP (Good Laboratory Practices - FDA, EPA, and OECD) regulatory requirements and ISO 9001 quality standards.

•Maintain Quality Assurance program by keeping current on all applicable government regulations and guidance documents and implementing changes as needed.

•Act as host for any Regulatory Agency or Sponsor audits.

Auditing/Inspecting

•Conduct external CRO GLP facility audits as necessary.

•Audit/inspect GLP/GMP projects to demonstrate compliance with GLP/GMP regulations - includes protocol, method of analyses, in-phase, raw data and final report inspections.

•Perform facility inspections for Analytical Research Services Department.

Document Review and Approval

•Review and approve protocols and final reports for GMP analytical testing for medical devices.

•Review and approve equipment qualification plans, protocols and reports.

•Review and approve laboratory investigations, OOS (out-of-specifications), unusual results and deviations for GMP medical device testing.

•Prepare and maintain Quality Assurance Unit (QAU) SOPs and review/approve all SOPs which govern GXP activities to assure compliance with regulatory and industry standards.

•Monitor equipment qualifications and change control activities.

•Assist laboratory personnel in the determination of Part 11 compliance via risk assessment for analytical instrumentation and approve final out come to ensure compliance.

Administration

•Provide reports of any deficiencies to Management and ensure resolution through CAPA system for continuous improvement.

•Verifiy to Management that facilities, equipment, personnel, procedures and policies are in conformance as with appropriate government regulations and industry standards.

Personnel Training

•Provide GXP training for personnel involved in GXP activities.

Quality Assurance Associate May 1996 – September 2006

Program Management

•Ensured all quality records and standard operating procedures (SOPs) were developed, maintained, and controlled consistent with GLP/GMP compliance and ISO quality system.

•Wrote necessary quality assurance SOPs and assisted in the review and development of other SOPs as required to assure compliance with applicable regulations (EPA, FDA, and OECD) for GLP/GMP activities.

Auditing/Inspecting

•Audited GLP/GMP activities to demonstrate compliance with GLP/GMP regulations.

•Performed facility inspections for Analytical Research Services Department.

•Conducted external CRO facility audit when necessary.

Documentation Review and Approval

•Managed all controlled documents.

•Reviewed and approved laboratory investigations, OOS, unusual results, and deviations for GMP activities.

Training Personnel

•Provided GXP training for personnel involved in GXP activities.

Archiving

•Managed paper and chemical archives.

•Ensured proper archiving of test samples received for GXP studies, and inventory of primary standards.

Ciba Geigy Corporation, Summit, N.J.

Associate Scientist II May 1993 - April 1996

Analytical Laboratory Testing

•Developed analytical methods to determine drug levels in biological fluids using HPLC for GLP studies.

•Validated and performed analysis of drug levels in biological fluids using HPLC and Laboratory Robotics techniques under GLP and GCP standards.

•Determined protein binding in biological fluids.

Documentation and Report Writing

•Assisted in the preparation of final GLP study reports.

•Assisted in creation of departmental SOPs.

•Calculated pharmacokinetic parameters and perform summary statistics.

•Tabulated and prepared graphs for the pharmacokinetics of drug level data.

Ciba Geigy Corporation, Ardsley, N.Y.

Assistant Chemist June 1990 – April 1993

Research/Development and Process Optimization

•Researched and developed new organic fluorochemical products.

•Created two new cost efficient processes for the development of two industrial products.

•Performed organic reactions from 0.5 - 12 liter scales to optimize purity, yield, and reaction time.

•Performed applications of internal and external paper sizes.

•Formulated specific sizing for paper mill products.

Technical Resource and Training

•Interfaced with customers as a technical assistant to the Sales Force.

•Educated Sales Force on Ciba-Geigy's fluorochemical paper sizing technology.

PROFESSIONAL ORGANIZATIONS

Active member of the Society of Quality Assurance (SQA)

Member of Medical Device Specialty Section and Planning Committee of SQA

Member of the Mid-Atlantic Region Society of Quality Assurance

References furnished upon request.

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