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Manager Quality

Location:
Irvine, CA, 92604
Posted:
March 23, 2021

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Resume:

Experience

Responsible for supervising QC

Microbiologists and microbiology associates responsible for performing physical testing such us Sterility testing of raw material and finish products as well Endotoxin and PM testing,environmental monitoring sampling, quality investigations and resolution and batch record review and release .

Ensures that personnel operate efficient and effectively while performing routine and non routine tasks.

Schedules and coordinates a wide variety of testing and monitoring activities and performs associated supervisory duties.Perform final review of test data/reports to ensure conformanceto the established specifications and other related standard operating procedures.

Investigate deviations to determine the impact on the product quality, the cause and corrective actions to preclude further deviations of similar nature.Prepares protocol;s and technical reports for validating changes to existing products and processes.

Assists with or prepares the annual department budget. Responsible for final technical review of completed production records prior to release to Quality Assurance.

Responsible for recruiting and training microbiologists. Responsible to coordinate investigations of deviations and non- conformances to identify the cause and to ensure that appropriate corrective and preventive action is taken.Prepares written investigate reports and analyses to monitor trends and quality issues. Theorical Knowledge of subject matter,CGMP,FDA guidelines,GLP and USP's.

Microbiologist Supervisor

/Manager

BBraun Laboratories - Irvine

California

November-2002 - Currently

Coordinate execution of routine microbiology activities and special projects with the QC Technical Service Microbiology Lab Associates and cross-functional groups to ensure efficient and effective operation.Provide technical review, direction, and approval for routine microbiology testing. Execute and lead microbiological validations and testing

Microbiologist

SICOR Pharmaceutical - Irvine,

California

November-1991 - November-2002

Objective

A position where I can utilize my 30 years of experience in the Pharmaceutical/Medical Biotechnology industry. Phone 714-***-****

Address 15 Calandria Irvine,CA 92620

Email ***********@***.***

Rolando Ferreira

Skills

Bilingual (English,Spanish)read, write and speak, Excellent mathematical skills, Easily oriented to job responsibilities, Flexible to work alone or in a team environment, Have the ability to be creative and execute new ideas. Education

General Education

Bell High School - Bell California

1979

Irvine Valley College - Irvine Biology,Microbiology courses. California

Orange Coast College - Costa Mesa Various Chemistry courses California



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