QA Engineer

Description Overview

Provides primary Quality Assurance review and approval for deviations, change controls, and other cGMP documentation and studies and ensures that all information and documentation conforms to company policy, cGMP’s and all other applicable FDA guidance’s.  Assists with monitoring of cGMPs throughout the facility and is a first responder to quality events on the shop floor.  Assists with validation and verification activities for enhancements in the facility from a food safety and quality perspective.  Assists with the assembly of Annual Management Review materials.

Scope of the Role

• Responsible for reviewing and approving documents such as deviations, management reviews, non-routine batch status change requests, planned deviations, calibration non-conformances, etc.  First responder to quality events on the shop floor and provides initial risk assessment.
• Works with operations, laboratory, engineering, and maintenance managers and staff to develop, evaluate and implement action plans which maintain or improve product and process quality.
• Develops and implements procedures, processes and documentation that are used to ensure the Company’s quality standards are met and maintained.
• Participates in quality driven initiatives in the continuous support of Quality Improvement.  
• Entering data into a CAPA system that will be used to identify trends and/or root causes; they shall also be responsible for participating in comprehensive investigations as necessary.  
• Completes internal audits to ensure compliance to cGMPs and codes company is certified to.
   

Experience Required

• Bachelor’s degree in food science, microbiology, or closely aligned field
• Minimum five years’ experience in and knowledge of manufacturing in infant formula, food or beverage industry is preferred. 
• Demonstrated understanding of and ability to apply cGMPs and US FDA laws and requirements in an FDA regulated industry.  
• Demonstrated ability to organize multiple tasks and change priorities to meet project deadlines. 
• Excellent analytical skills are essential, including well developed interpersonal skills. Prior professional experience in inspection, quality control, and release in infant formula, food or beverage industry is preferred.  Computer literacy is required.