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Quality control/assurance and regulatory compliance specialist

Location:
buffalo, NY
Salary:
$40k/ yr
Posted:
November 04, 2009

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Resume:

Sarah D. Caputi

***** ***** **. ***********, *** York 14062

Phone: 716-***-**** E-mail: r4dxzs@r.postjobfree.com

QUALITY CONTROL/ASSURANCE AND REGULATORY COMPLIANCE SPECIALIST

Accomplished professional with hands-on experience in Quality System creation and improvement to ensure compliance with government entities, third party audit specifications and export requirements seeks a Quality Management position with a socially responsible food manufacturing company.

C O R E C O M P E T E N C I E S

- Completed FDA Better Process Control School

(Aseptic Process Authority)

- Intimate working knowledge of HACCP, ISO 9001,

ISO 14000, GMP, GLP, SSOP

- Fluent in French, functional with Spanish.

- Computer literate with competencies in MS Word, Excel,

Power Point, Front Page, and Publisher

- Strong foundation and experience with continuous

improvement practices including SPC and TQM

P R O F E S S I O N A L E X P E R I E N C E

Iovate Health Sciences, Inc. USA, Hamburg, New York July 2007 – May 2008

Quality Assurance Specialist

Created a quality system to ensure compliance with new federal regulations for Dietary Supplements for an international Dietary and Sports Supplement Company. Duties included supervision and training of employees for compliance, authoring SOPs, physical/sensory testing of incoming products, investigations of consumer complaints and quality issues, verifying overseas labeling regulations for international container shipments, investigation and approval for reclaimed/returned items to be restocked.

· Authored all SOPs and corresponding recording keeping forms within deadlines.

· Contributed waste management ideas and brokered a deal to turn potentially land-filled, obsolete packaging into a revenue stream for company.

· Worked with all departments affected to base new Quality System on current practices to ensure compliance with minimal stress and appropriate frequency.

Rich Products, Inc., Buffalo, NY

Quality Assurance Technician (March 2005 – September 2005, February 2007 – June 2007)

Contract key off-shift employee responsible for sample collection, microbial analysis, performance and sensory evaluation for dairy based, non-dairy and commercially sterile beverage products for retail and institutional use in a New York State certified laboratory; conducted plant audits for adherence to GMPs, HACCP, state and federal regulations for food produced for consumption in the U.S. and abroad; served as back-up Process Authority for the Buffalo plant.

· Utilized advance microbial detection methods such as RABIT.

· Initiated holds and corrective actions for process deviations, poor performance and adulteration.

· Supervised other contract employees.

Regulatory Technician (September 2005 – June 2006)

Contract employee responsible for generation of label information for company products intended for sale in North America in accordance with FDA, Health Canada and Mexican guidelines; allergen assessment of products for customer information; additive analysis for U.S. and Canadian products; label proof review for final approval of package labeling.

· Worked as part of a team to ensure all newly reformulated products were correctly labeled in accordance with the change in regulation for items containing trans fats in advance of deadline.

Ford Brothers Wholesale Meats, Inc., West Valley, New York

April 2003 - August 2004

Quality Control Coordinator

Authored all revisions to the HACCP plan and created current quality program for a USDA inspected slaughter and processing operation. Reviewed all documents for pre-shipment review, conducted pre-operational & operation inspections to monitor sanitation and compliance, directed sanitation crew as needed, collected samples for and conducted microbiological testing for sanitation and pathogen reduction standards. Maintained records in accordance with USDA guidelines, responded to Non-Compliance reports, researched options to provide cost effective testing and pathogen control, ordered all laboratory supplies. Created and maintained current documentation for OSHA, Cattaraugus County Health Dept. and NYS DEC.

· Supervised employees for HACCP verification.

· Researched and implemented additional cost effective pathogen reduction standards.

· Worked in conjunction with the USDA as plant liason to remedy situations and address concerns in order to promote cooperative food safety atmosphere.

New York State Department of Agriculture & Markets, Buffalo, New York

Oct. 1998 – Sept. 2000

Food Safety Inspector

Conducted inspections of retail food establishments and processing facilities to insure proper sanitary procedures were in use to reduce the potential for food born illness and/or injury in accordance with New York State law and the FDA Food Code, investigated potential food born illness cases, reviewed food labeling and advertisement claims for compliance with state and federal regulations, prepared reports and forms for establishment history files, attended industry functions on behalf of and with the Buffalo Office.

· Prepared evidence and gave testimony for court hearings.

CPS Corp., Dunkirk, New York

September 1994 - May 1998

Chemist, QC Lab Coordinator & Tech., Environmental Dept. intern

Conducted troubleshooting of production batches, daily testing and formulation adjustments to achieve customer specifications. Responsible for record keeping, supervision of QC staff, assisted in the creation, implementation, monitoring and reporting for ISO 9001 and ISO 14000 systems. Conducted sampling for environmental monitoring and reporting.

E D U C A T I O N

State University of New York College at Fredonia

Bachelor of Science in Biology

Chemistry minor, Environmental Science concentration



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