Quality Control Manager

Michelle Caluag Scott

Address: **** ****** *** ***. ***, Oxnard, CA 93036

Contact No: 805-***-****

Email address: ***********@*****.***

Highlights of Qualifications

Well versed in Microbiology theories, principles and applications.

With over 10 years experience in Microbiological laboratory analyses in

cosmetic manufacturing, pharmaceutical and clinical/ veterinary

environment. A Bachelor of Science in Microbiology graduate from the

University of Santo Tomas in Manila, Philippines. Earned units in

postgraduate studies in Microbiology also from the University of Santo

Tomas. Self-motivated and flexible with good written and oral

communication, analyzing and planning skills.

Work History

1. Deiskin Cosmetics and Drugs Laboratory, Inc.

2 Hope St. Grace Village, Balingasa, Quezon City, Philippines 1115

Quality Control Manager (November 2008 - September 28, 2012)

. Formulated and implemented Quality Control plans/ programs for the

continuous improvement of Quality Control processes

. Provided approval and/or rejection of Raw Materials, In-Process Bulks,

Finished Goods and Packaging Materials

. Verified the reports of non-conformances in raw materials and

packaging materials, compounded bulks and finished goods from issuance

up to closure

. Validated the corrective and preventive actions taken for non-

conforming raw materials, in-process bulks, finished goods and

packaging materials

. Coordinated with Quality Control Analyst/ Microbiologist regarding

investigation and validation of products with complaints

. Reviewed laboratory requirements and approved requisitions as

necessary

. Ensured that all laboratory equipment are calibrated according to the

Annual Calibration Plan

. Coordinated with Quality Control Analyst and Microbiologist on the

development and validation of test methods required for materials and

products

. Monitored GLP and GMP compliance of the department as well as other

units in Plant Operations

. Ensured effective implementation of the Environmental Program of the

department

. Coordinated with other departments on Quality related issues and

concerns

. Conducted regular training to all department personnel on designated

work assignment, standard operating procedures and GMP compliance

. Created Standard Operating Procedures for the Quality Control

Department

. Created the company's Site Information File as per requirement of the

FDA Philippines

. Created the company's Quality Manual

Technical Services Supervisor (February 2009 - September 28, 2012)

. Conducted the company's clinical trial on whitening together with the

Technical Services Head and selected Dermatologists

. Recruited and qualified subjects for clinical trials/ studies

. Created questionnaires for the product safety and efficacy assessment

of new products developed by R&D

. Conducted interviews/ assessment on effectivity and safety of the new

products

. Performed melanin drop assessment of selected respondents using SPA 99

mexameter

. Prepared protocols and reports of the clinical trials and studies

Microbiologist (November 2008 - September 28, 2012)

. Conducted sampling, inspection and microbiological analyses of raw

materials, in-process bulks, and finished goods such as cosmetic

products and food supplements

. Implemented Environmental Monitoring Program of QC department

. Created Work Instructions for the Microbiology Section

Quality Control Consultant (July 2008 - September 2008)

. Formulated Quality Control plans/ programs to establish QC processes

. Reviewed all requirements and led the team to comply with cGMP

standards

. Verified corrective and preventive actions if certain processes

deviated with the standards

. Coordinated with the team in the development and validation of test

methods and qualification of new products

2. Splash Corporation

Canumay West, Valenzuela City, Philippines

Quality Assurance Supervisor (December 2006 - June 2008)

. Handled the Incoming and Outgoing Inspection, Analytical and

Microbiology Section of the QA laboratory

. Ensured on-time sampling, inspection and analysis of raw materials, in-

process bulks and finished goods and on-time releasing of results

. Conducted regular review of all laboratory equipment status and make

sure that these are calibrated according to the annual calibration

plan

. Ensured that development, validation of test methods and qualification

of new products were properly coordinated with QA Analysts and

Microbiologist

. Monitored non-conformances/ deviations from specifications and

verified corrective and preventive actions taken from in-process

bulks, raw materials and finished goods

. Prepared summary of Cycle Time Reports for each section

. Assisted QA Manager in the formulation of QA Plans, monitoring and

implementation of these programs

. Assisted QA Manager in ensuring GMP compliance of the whole

manufacturing facility

. Ensured that quality related issues and concerns are regularly

coordinated with interfacing departments

. Ensured implementation of Environmental Monitoring program of QA

Department

. Ensured complete and updated documentation of all QA processes

Microbiologist (February 2004 - November 2006)

. Ensured that sampling, inspection and microbiological analyses of raw

materials, in-process bulks, and finished goods such as creams,

lotions and other cosmetic products were properly carried out in

accordance with GMP and GLP requirements

. Provided microbiological support to R&D by developing the company's

Preservative Challenge Test and Percent Kill Test for new products

. Performed identification of microorganisms using API 20E System

. Conducted microbiological testing of products under stability

. Implemented Environmental Monitoring Program of QA department

. Handled the Microbiology laboratory and ensured all its equipment and

apparatus are calibrated according to the annual calibration plan

. Ensured the availability of laboratory reagents and supplies needed

for microbiological analyses

3. Ace Pharmaceuticals, Inc.

Norzagaray, Bulacan, Philippines

Microbiologist (September 2002 - February 2004)

. Performed microbiological test procedures for raw materials,

intermediates and finished goods such as syrups and suspensions as

defined and required by the company

. Developed the company's antibiotic assay procedure using cylindrical

plate method for Erythromycin

. Ensured that all products released by the company meets the required

Microbiology standard

. Conducted regular environmental sampling such as air sampling, swab

test and water analysis in the different areas of the plant

. Prepared media and reagents used for microbiological analyses

. Handled and maintained the Microbiology Section, its equipment and

supplies

. Created Standard Operating Procedures for the Microbiology Section

4. Simian Conservation Breeding and Research Center

Tanay, Rizal, Philippines

Microbiologist (March 1998 - May 2000)

. Conducted microbiological sampling on swab samples from monkeys

preserved in the breeding center

. Performed microbiological clinical testing for the detection and

identification of microbial isolates from swab samples using API 20E

System

. Performed antibiotic assay procedure using disc plate method

. Ensured that swab samples are negative for pathogenic microorganisms

or immediately reported, if diagnosed to be positive to the department

responsible, to protect and save the animals from diseases and

infections

. Prepared media and reagents needed for Microbiological testing

Educational Background

2001-2007 University of Santo Tomas M.S. Microbiology

Espa?a, Manila, Philippines

(units only)

2000-2001 University of the Philippines M.S.

Microbiology

Los Ba?os, Laguna, Philippines

(units only)

1993-1997 University of Santo Tomas B.S. Microbiology

Espa?a, Manila, Philippines

Professional Affiliations

. Philippine Society for Microbiology, Inc.

. Philippine Academy of Microbiology

. Philippine Society for Cosmetic Science, Inc.

. University of Santo Tomas Microbiological Society

Accreditation

Registered Microbiologist accredited by the Philippine Academy of

Microbiology

(year 2002)

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