Medical Device Quality Assurance

MARGARITA LOPEZ-VASCO

***** ******** **. # **-* Carson CA. 90746

Cell: 949-***-**** ● e-mail: ***********@*********.***

LinkedIn URL www.linkedin.com/in/mlopezvasco8912

SUMMARY

GMP Quality Assurance Specialist with extensive experience in analytical method validation providing support to Analytical Services department. Skilled in validation document writing, reviewing and approving. Able to balance the pressure to meet deadlines maintaining the quality of the document review process. Utilizes strong organizational and planning skills towards creating procedures that streamline QA’s review and approval of all validation and product release documents required for clinical studies and ANDAs submission and manufacturing. Expertise includes:

• Internal Laboratory Auditing

• GMP Enforcement

• Analytical Chemistry

• HPLC System Qualification and Maintenance

• HPLC Method Development and Validation

• GMP/ISO/ICH Regulated Environment

• Training Material Preparation • Chemistry College Professor Experience

• Microbiology Experience

• Technical Writing

• Agile Document Control System Software

• Computer Literate – MS Office

• Bilingual (Spanish / English)

• Instrumental Analysis

• Experience with aseptic processing

PROFESSIONAL EXPERIENCE

ANCHEN PHARMACEUTICALS, Irvine, CA 2008 - 2011

An emerging pharmaceutical manufacturer of generic modified release solid dose products

Sr. Chemist QA (Specialist)

Performed R&D and Quality Control documentation compliance review and approval of method validation / qualification protocols and reports, SOPs, instrument qualification protocols and reports, new, executed and revised specifications quality assurance reports (SQARs), stability report, process validation protocols (MPSPs), analytical deviations and investigations (CAPAs), ANDA’s submission summaries. Performed R&D/QC laboratory internal audits and wrote audit reports. Provided training to QA Technicians.

• Assisted in building portfolio of 60 modified release products in a 3 year time period.

• Supported R&D Lab and regulatory affairs in an ambitious submission program of 25 ANDAs in a 30 month time period.

• Achieved annual timely compliance review of 1930 documents (in 2010) to support the rapid development of company’s portfolio.

• Reduced the number of deficiencies in FDA’s letters by proposing required validation work for completeness, and ensuring that correct specifications were set for each validation characteristic.

• Executed investigations to solve process cleaning validation issues.

• Trained a group of QA Technicians on 45 existing cleaning validation method and techniques.

ANALYTICAL PHARMACEUTICAL DEVELOPMENT, Orange County, CA 2006 - 2008

Independent Pharmaceutical Development Consultant

Provided Analytical Method Development and Validation expertise at various pharmaceutical and medical device firms including AMO, Irvine Analytical and Alliance Medical Products.

• AMO (Medical Device Company) - Performed technical writing, process validation activities and actively assisted in completing documentation for the PRISM design lens submission.

• Alliance Medical Products (Medical Device Company) - Performed Lab Supervisor duties, technical writing, and planned and initiated analytical laboratory transfer to new facility in 60 days.

• Irvine Analytical R&D (Contract Laboratory) - Development two HPLC methods and wrote numerous analytical method validation protocols.

WATSON LABORATORIES INC., Corona CA 2003 - 2006

One of the 5 largest pharmaceutical company’s in USA. Manufacturer of ANDA pharmaceutical products.

Scientist III

Performed analytical method development, validation, optimization, qualification and verification studies in a GMP regulate environment at Laboratory Operations (LTS Group). Delivered protocol and report writing using FDA / ICH guidelines.

• Participated in FDA inspections in 2003 and 2004.

• Actively contributed to compliance, with the commitment to FDA to re-develop and/or re-validate, and verified all test methods used in quality control laboratory.

• Reviewed and corrected contract labs validation work in order to comply with commitment.

• Executed preventive and corrective action plans of LIRs thereby ensuring investigations were closed in the specified period of time.

PARAGON LABORATORIES INC., Torrance, CA 2002 - 2003

One of the most steady nutritional supplements manufacturers in California

QC Manager

Supervised and coordinated Quality Control department in a GMP regulated environment. Oversaw receiving, quarantining and manufacturing inspection. Reviewed test results and released raw materials, packaging goods and finished product. Supervised analytical and microbiological lab activities.

• Managed team and set-up a new microbiology lab in two weeks.

• Established a data recording procedures, a secondary standard evaluation and tracking system, initiate monitoring of system suitability prior to testing, and wrote and implemented new test methods and SOPs, all in seven months.

INDEPENDENT R&D CHEMIST, Irvine, CA 2001 - 2002

Performed method development, validation and verification studies for pharmaceutical and medical device companies based on FDA / ICH guidelines.

• Gram Laboratories, Inc. (Contract Laboratory) - Participated in the development and validation of one dissolution test method, one GC residual solvents method for raw materials and in an assay test method for finished product in solid dose.

• B. Braun Medical (Drug Delivery Systems Company) - Assisted in developing, and validated gas chromatography analytical method to detect antibiotics contamination with leachable components extracted from packaging components at trace levels. Performed yearly qualification of 7 HPLC systems.

EDUCATION

Master Degree in Human Development

ITESO - Instituto Tecnológico de Estudios Superiores de Occidente (Loyola University)

Guadalajara Jalisco México

Bachelor of Science, Pharmacology Chemist and Biochemist

University of Guadalajara, Chemical Sciences Faculty, Guadalajara Jalisco México

PROFESSIONAL DEVELOPMENT

Certificate: Instrumental Analytical Chemistry, University Autonomous of Guadalajara

Presently Working on Internal Audit Certification

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