Job Title: Quality Assurance Manager
Reports to: Director of Quality Assurance
Location: Alexandria, MN
FLSA code: Exempt/Full-time
The position provides overall plant leadership in the Quality and Regulatory Compliance Areas for the SunOpta Aseptic -3915 Minnesota St. facility. The position is responsible for design and implementation of standards, policies, and procedures to ensure that quality requirements are met during production. This position will directly oversee testing of processes and products.
- Actively participates in the Aseptic Leadership Management Team activities (team meetings, developing quality KPI’s, keep peers informed, quality resource to team, follow up on quality assignments, and involve all levels of the organization in problem solving.
- Work with Staff to coordinate audits of Manufacturing Operation, and inspection, evaluation and testing of product to insure product meets the product specification. Hire, discipline and coach staff.
- Designs, develops, implements, and administers a comprehensive Quality Management System to control company exposure to risk. Designs, develops, implements, and administers the Plant Quality Programs.
- Receives customer complaints, maintains a log, investigates complaint, and provides response back to customer.
- Acts in the capacity as of the official liaison between the plant and regulatory bodies (FDA, USDA, MNDA, customer quality reps, auditors, etc….)
- Ensure that all details relating to test runs, product changes, and new products are complete prior to scheduling for production.
- Manages facility kosher program and insures compliance with kosher requirements.
- Manages facility Organic program and insures compliance with Organic requirements.
- Establishes and manages the facility allergen program.
- Maintains and distributes the most current batch record for manufacturing use. Develops manufacturing records to insure documentation proving traceability, regulatory compliance, customer compliance, and GMP compliance.
- Insures that raw materials are in compliance with customer or company requirements prior to use. Develops raw material and ingredient specifications to ensure materials are in compliance with customer requirements for use.
- Develops, implements, and maintains a Quality Hold Program to isolate, quarantine, and freeze non conforming product. Investigates all finished product and raw material out-of-compliance occurrence and determines a disposition. Ensures submittal of defective material claims.
- Reviews all records pertaining to product production.
- Reviews all records pertaining to product production prior to product release. Responsible for the official release of all finished goods and raw materials.
- Leads all investigations into out-of-spec products. Rapidly develops probable causes and proposes corrective action plans. Advices Management on actions needed. Provides report on findings to Management.
- Establishes and maintains the Retention Sample Program.
- Provide regular GMP audits of the facility noting any compliance issues. Provide a report to Management on findings.Provide regular updates and a monthly report of activities
- Supervise QA Staff
To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. Individual must be a self-starter capable of working in a team based environment. The requirements listed below are representative of the knowledge, skill and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
Educational and/or Experience
Bachelor’s degree (B.A.) in a technical field from a 4-year college or university or more than 8 years related experience and/or training; or equivalent combination of education and experience.
SunOpta is a leading global company with a focus on natural, organic and specialty foods. We specialize in the sourcing, processing and...