Manager Quality Assurance

Experience

Quality Assurance Associate Feb. ***0- Aug.

2010

InterHealth Nutraceuticals/Benicia,

CA

. Ensure the accuracy of all Q.C. records and related documents.

. Conduct Packing Room environmental testing once a month and record

data.

. Manage sampling procedures and prepare pre-shipment samples for

analysis by approved Labs.

. Review results from approved laboratories against product

specifications.

. Release products per approved SOP's and VP Operation approval.

. Check shipping document prior to products shipping daily.

. Perform GMP audit once a month and record data.

. Maintain and update ISO files.

. Work with VP Operation to modify procedures, specifications, CofA,

etc.

. Coordinate internal and external CA and PA reports.

. Coordinate internal audits.

. Schedule and prepare for ISO Management Review Board.

Specimen Processor Technician I Mar. 2007 -

Jan. 2009

Quest Diagnostics/ Las Vegas

NV

* Excellent organizational skills

* Demonstrates great understanding of compliance policies related to

record and batch keeping.

* Excellent auditing skills when reviewing specimen submissions

* Communicates well and collaborates with other departments.

* Meets standards for production and accuracy within 6 months.

* Understands the complex relationship between test(s) ordered and

specimen received.

* Completes all assigned reports with attention to detail.

* Cross-trains well within multiple departments

IT Data Clerk Nov. 2005 - Oct

2006

Conceptus Inc. / Mountain

View, CA

* Contact, training and sign off data input to database (CRM) from field

sales and trainers and other sources.

* Maintain/edit/update training database.

* Maintain training files for "trained physicians".

* Act as liaison with sales force, trainers, and internal personnel to

ensure work meets or exceeds customer expectations.

* Complete projects and tasks in an aggressive manner consistent with

corporate objectives.

* Keep manager informed of changes in work schedule and/or workload.

* Support company goals and objectives, policies and procedures, Good

Manufacturing Practices and FDA regulations.

* Perform other duties as assigned.

Lab Assistant- Shipping/Receiving Coordinator Dec.

2002- Oct. 2005

Shipping/ Receiving Coordinator Genomic Health, Inc /

Redwood City, CA

* Participated in the Mock run prior to launch (Hands on skills in

filling out Requisitions in CRM).

* Proficient in Material Manager (Creating parts, lots and locations.

Locating items and handling shipments.).

* Efficient in Purchasing (calling vendors, placing orders and following

up on orders).

* Tracking inventory (thru Laboratory Explorer) and restocking.

* Competent in GEMTools (Creating labels.)

* Barcode labeling plates, oligos and various inventory items.

Education

2007 San Francisco State University San

Francisco, CA

* Bachelors Degree in Criminal Justice

2007 City College of San Francisco San

Francisco, CA

* Forensic Identification Certificate

1997 Solano Community College Suisun City,

CA

* Associates Degree in Liberal Arts

Laboratory Skills

Isolation of Microbes from a Mixed Culture, Assay of Microbial Enzymes,

Fermentation and Aerobic Respiration, Skilled in determining pH and

titration measurements, Good working knowledge of laboratory preparation,

pipetting, measuring scales, autoclaves, and GMP.

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