Director of Quality Assurance

DIRECTOR OF QUALITY ASSURANCE

ASEA is looking for a talented and enthusiastic Director of Quality Assurance to join our team. ASEA is regularly included on Utah's Best Places to Work and have a tight knit team that work hard and play hard. Perks include working in a brand new, very cool, office space.

SUMMARY:

The Director of Quality Assurance is responsible for strategic development and implementation of all Quality initiatives and ensuring strict adherence to FDA and all other applicable regulations. The position provides leadership and direction to the Quality Assurance/Quality Control team.

RESPONSIBILITIES:

• Administers, designs, and maintains the quality assurance systems required for maintaining Current Good Manufacturing Practices (cGMP) in food ingredients and dietary supplements in accordance with Food GMP (21CFR117) and DSHEA GMP (21CFR111) federal regulations.
• Regularly surveys and performs analysis of the quality assurance systems and regulations used in the food ingredient and dietary supplement market to ensure that ASEA meets or exceeds the industry standards for quality systems.
• Establish quality and reliability standards of raw materials, in-process product, and disposition of finished products.
• Work with the Regulatory department to ensure that key specifications for product purity, food safety, quality systems, product analysis, and packaging and labeling are properly documented and implemented by ASEA.
• Works with the Purchasing department to audit and assess the quality systems of raw material suppliers, contract manufacturers, and other vendors to ensure conformance to the ASEA quality assurance program.
• Maintain product quality
• Prepare product and process quality reports, analyze information and trends, and establish documentation system.
• Develop Standard Operating Procedures (SOPs) and implement other quality assurance policies and procedures.
• Works with the Operations and Engineering department to assist in development, documentation, and monitoring of Hazard Analysis and Critical Control Points (HACCP) to ensure critical food safety parameters are maintained in ASEA products.
• Supervises internal inspectors, reviews and approves inspection reports.
• Achieve financial objectives by preparing the quality assurance budget; scheduling expenditures and analyzing variances.

QUALIFICATIONS:

• Bachelor's Degrees in Chemistry, Biology or Food Science required, Master's preferred (or equivalent work experience).
• 10+ years of QA experience in cGMP food or dietary supplements required.
• 3+ years of experience in quality leadership position required.
• Familiar with 5S lean manufacturing, Six Sigma certification green belt minimum and SPC principles.
• Previous audit experience required. (i.e. NSF, FDA, UDOA, Kosher, HALAL, ISO)
• Broad general experience and familiarity with the wide range of industry-standard quality assurance systems, including, but not limited to: Food GMPs (21CFR117), DSHEA GMPs (21CFR111), Hazard Analysis and Critical Control Points (HACCP), ISO22000, Failure Modes & Effects Analysis (FMEA)

• Broad experience in authoring, reading, understanding, and evaluating: HACCP or FMEA action Plans, Corrective Action/Preventive Action (CAPA) plans, Federal regulations and procedures,
• Experience in best business practices for interacting with customer contacts and commercial relationships from a quality assurance standpoint is desired.

• Strong working knowledge of laboratory techniques and instrumentation (i.e. HPLC and IC chromatograph)
• Electronic document management systems experience preferred.
• Knowledge of documentation control requirements for cGMP regulated industries to meet FDA regulations desired.
• Oversees and/or reviews all finished product quality information and provides final release approval.
• Experience with Direct Sales, MLM, or Network Marketing industry a plus.

Current Openings for Director of Quality Assurance Jobs at ASEA

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