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Quality Manager

Location:
Centereach, NY, 11720
Posted:
September 16, 2015

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Resume:

Tejas Vakharia

** ****** ****

Centereach, NY ***20

Tel: 917-***-**** acrp39@r.postjobfree.com

Profile:

Engineering background with an expertise in FDA regulations, GMP, HACCP, SQF 2000 Level 2 codes, 5S, LQMS, Auditing, Calibration, Designing and Development of Quality improvement system.

Professional Experience:

NBTY - Bayport, NY June 2015 – July 2015

Quality Assurance Supervisor

Leaded a team of 20 team members (QA Techs) to achieve quality metrics in a manner consistent with our culture and values.

Partnered cross functionally with the Planning, Production, and Warehouse teams to maximize results.

Coached, mentored and developed team members to meet current and future business requirements.

Assisted the QA Manager with leading all company Quality initiatives and Quality audits.

Tracked, analyzed, and lead initiatives for all quality and customer complaint issues within the plant.

Ensured compliance and record keeping for all mandated quality checks, testing, sampling and sanitation activities.

Managed budgeting, purchasing and inventory of plant operating supplies such as filters, chemicals and lab supplies.

Used continuous improvement methodologies and projects to improve and streamline quality processes.

Ensured plant compliance to good hygiene practices, good manufacturing practices (GMP's) and HACCP.

Communicated new quality programs as needed and facilitate or support the training of plant personnel

Responsible for recording keeping requirements within the laboratory.

Tasty Brands, LLC - Syosset, NY January 2014 – April 2015

Quality Assurance Manager

Performed regular on-site audits of production and distribution facilities. Auditing of each facility are performed as determined by need and past history. Enforced all quality and food safety procedures thru ought manufacturing, distribution and warehouse.

Developed and lead QA department to ensure productivity, communication and development of employees.

Developed long and short term goals for Quality Assurance program including capital and operating budgets.

Oversee corrective and preventive action (CAPA) program and provided recommendations to producing plant on corrective actions and improvement for better efficiencies, throughput and cost-savings.

Reviewed and maintained customer complaint handling program.

Maintained compliance with FDA and USDA. Including SQF, FDA and USDA audits.

Reviewed product samples visually and perform organoleptic evaluation, use outside lab services periodically to assure chemical and nutritional compliance. Assured timely delivery of product for compliance review.

Maintained product specifications, nutritional information databases and marketing information using Genesis.

Assisted the Director of Technical Services in assuring that new and existing products supplied meet all specifications of safety, compliance and consistency.

Kozy Shack (A Proud Division of Land O’ Lakes) - Hicksville, NY May 2011 – December 2013

Quality Assurance Support

Implement Quality System; create standard operating procedures and calibration programs for equipments.

Enforcement of all quality and food safety procedures thru ought manufacturing, distribution and warehouse.

Providing technical support on special projects, new R&D trails and relevant quality analysis.

Implemented procedures for Quality Control as per HACCP requirement.

Created and maintained proper procedure for pre-operation

Interviewed, trained and supervised new and existing QC Technicians.

Audit documentation for Quality, Production, and Sanitization and Maintenance departments.

Organoleptic evaluation of finish product on daily basis.

LNK INTERNATIONAL, INC - Hauppauge, NY September 2010 – May 2011

Quality Assurance Officer

Implement Quality System; create standard operating procedures and qualification programs for instruments.

Maintain documentation as per FDA requirement to meet cGMP audit requirements.

Developed guidelines and implementation procedures for Quality Control as per 21CFR Part 11.

Ensure proper handling of Planned and Unplanned Deviation and Vendor Samples.

OSI PHARMACEUTICALS, INC - Melville, NY June 2008 – September 2008

Asset Management Specialist (Facility Management)

Participated in configuring, implementation and maintenance of asset management system.

Performed audit functions by conducting field inspections, compiling asset data and internal reporting.

Coordinated requirements gathering session for future releases of the asset management system.

Selected, mentored, evaluated and trained staff to correct asset related deficiencies.

Manage work requests and CMMS system (Micro Main) for equipment repair and preventive maintenance.

CERTIFIED LABORATORIES, INC - Plainview, NY March 2002 – June 2007

Assistant Manager

Guided clients when releasing multiple product lines for Food & Drug Administration (FDA) approval.

Coordination between customers and FDA for product sales in US including daily reporting.

Certification by National Fisheries Institution (NFI)/FDA and by Yum Brand for seafood sensory evaluation.

Recruited, trained and mentored employees in FDA standards and certification processes.

Certifications:

Sensory Evaluation by Rutgers University – September 2013

Texture Analyzer for Food Quality – February 2013

Sensory Evaluation (Seafood-Shrimp) by University of Florida & FDA – May 2007

Tuna, Mahi, Shrimp & other seafood Quality Evaluation by NFI & USDC - October 2005

Long John Silver (Yum Brands) Seafood Auditing Certification – May 2005

Computer / Technical Skills:

Software: Genesis (Nutritional and Labeling Software), Microsoft Office Suite, PhotoShop, Visio.

Engineering: Calibration & Installation of gauges, control valves, panel instruments.

Education:

Bachelor of Engineering – Instrumentation Engineering, University of Bombay, Bombay, India – 1997



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