Aseptic Technical Quality Specialist

job purpose:

Lead efforts across all manufacturing sites to reduce quality failures, improve manufacturing efficiency, and drive quality improvement initiatives. Work with process authority to support validation activities as part of new line extension and engineering change requests. Partner with equipment manufacturers to lead failure investigation activities to reduce product hold and deviation occurrences.

responsibilities:

• Lead RCA/CAPA process with operational and engineering teams to identify and assign cause to aseptic system failures and create solutions for reduction in product holds associated with aseptic system deviations
• Coordinate and support full line validation efforts with regulatory agency/process authority for approval of new line installation and/or line extensions. Serve as liaison between OEM and regulatory agency/process authority as required.
• Submit engineering change request (ECR) to process authority for all LACF system enhancements and changes. Serve as liaison between process authority and manufacturing sites for coordination of ECR approvals and validation requirements
• Support "Grade A" extended run requests and approvals. Serve as liaison between regulatory agency and manufacturing sites for request submittal and coordination of extended run trial protocols
• Support site engineering in equipment design and process improvement efforts to drive quality enhancements, improve operating efficiencies, and ensure compliance against LACF, PMO, and CFR standards.

skills/qualifications required:

• Bachelor's degree in microbiology, food science, engineering or closely related field
• Experience in a LACF quality assurance manufacturing environment
• Strong understanding of dairy microbiology
• High proficiency in computer technology and manufacturing systems operations
• In-depth understanding of dairy regulatory (PMO/CFR) requirements
• Strong understanding of RCA tools and ability to work with cross-functional teams to address quality failures
• Excellent verbal and written communication skills
• Able to work efficiently in a team environment
• Ability to support regulatory, GFSI, & ISO audits as needed

working conditions and physical requirements:

• Hybrid 40-45 hours as needed
• Ability to lift up to 50 pounds
• Travel 30-50%

food safety requirements:

• Notify supervision of any repairs or adjustments that are required that may affect product quality or food safety.
• Understand, observe, and comply with the handling and usage of the color-coded container policy while in the Production Areas.
• Perform all duties necessary to meet Company, Customer and/or Government requirements/standards as prioritized by the Company.
• Ability to initiate action to prevent the occurrence of nonconformities relating to Food Safety and the Quality of the product, processes, quality system, or safety system.
• Identify and record any problems relating to Food Safety and the Quality of the ingredients, processes, quality system, or safety system.
• Control further processing or delivery of nonconforming product in terms of Food Safety and Quality issues until the deficiency or unsatisfactory condition has been corrected.
• In the event of absence, another employee with the same skill level will assume the duties and responsibilities as required.

position location:Goodyear, AZ / Dexter, NM

reports to: Aseptic Technical Manager