Food & Safety QA Manager

SUMMARY:

The Food Safety & Quality Manager works with all departments as the Food Safety Subject Matter Expert (SME). This individual will lead the development, implementation, and continuous improvement of quality systems to ensure that our products meet or exceed the standards for Infant Nutrition Packaging.  This position plays a key role in facility risk assessments, on-site audits, and management of regulatory requirements as they relate to the food industry. The role also manages facility SQF compliance.

The Food Safety & Quality Manager collaborates within a broader team to ensure that final products are safe, reliable, and meet customer expectations while maintaining an effective and cost-efficient manufacturing process. This position serves as the key interface with customers, ensuring current and future food safety requirements are met. The manager must lead by example in embodying and driving the Company Core Values and High-Performance Work Culture.

ESSENTIAL DUTIES AND RESPONSIBILITIES:

1. Quality Management:

• Develop, Implement, and Maintain QMS: Design and enforce a comprehensive Quality Management System (QMS) that adheres to FDA regulations and industry best practices, ensuring all quality policies, procedures, and standards are up-to-date and consistently applied across all operations.

• Quality Policies and Procedures: Establish detailed quality policies and procedures, ensuring every aspect of production is documented and follows strict guidelines to maintain high product quality.

• Quality Control Activities: Oversee all quality control activities, ensuring they are conducted according to established protocols and industry standards, with a focus on continuous improvement and compliance.

2. Regulatory Compliance:

• Compliance with FDA Regulations: Ensure the plant meets all FDA regulatory requirements, including cGMP (current Good Manufacturing Practices), by implementing robust compliance programs and regular audits.

• Regulatory Documentation: Oversee the preparation and timely submission of all necessary regulatory documents and reports, ensuring accuracy and compliance with all regulatory requirements.

• Stay Current with Regulatory Changes: Monitor changes in regulatory requirements and adapt plant procedures and policies accordingly, ensuring ongoing compliance and readiness for regulatory inspections.

• Inspection Readiness: Ensure the plant is always prepared for FDA, Health Canada, and customer inspections, maintaining high standards of cleanliness, organization, and compliance.

3. Environmental Controls and Hygienic Zoning:

• Environmental Control Programs: Develop and implement comprehensive environmental control programs to maintain the highest standards of cleanliness and hygiene within the plant.

• Hygienic Zoning Protocols: Establish and enforce stringent hygienic zoning protocols to prevent cross-contamination and ensure product safety, regularly reviewing and updating protocols as necessary.

• Monitor Compliance: Continuously monitor environmental controls and hygienic zoning adherence, conducting regular audits and inspections to ensure compliance with internal standards and regulatory requirements.

4. Lab Oversight and Test Results:

• Direct External Lab Operations: Provide oversight and direction to external laboratories conducting testing for the plant, ensuring they adhere to established quality standards and regulatory requirements.

• Implement Testing Protocols: Develop and enforce rigorous testing protocols to verify product safety, quality, and compliance with regulatory standards, regularly reviewing and updating protocols as necessary.

• Analyze and Report Results: Ensure that test results from external labs are accurately recorded, analyzed, and reported, with any deviations promptly addressed to maintain product integrity.

5. Product Release:

• Enforce Release Criteria: Develop and enforce stringent product release criteria to ensure that only products meeting all quality and safety standards are distributed.

• Oversee Product Release: Coordinate with production and supply chain teams to ensure seamless and timely product release, maintaining high standards of quality and compliance.

• Regulatory and Quality Compliance: Ensure that all released products comply with regulatory and quality requirements, conducting thorough reviews and approvals before distribution.

6. Raw Material, Packaging, and In-Process Testing and Release:

• Ensure Compliance with Specifications: Oversee the testing and release of raw materials, packaging, and in-process products to ensure they meet all specified quality and safety standards.

• Testing Protocols: Develop and implement testing protocols for raw materials, packaging, and in-process products, ensuring compliance with regulatory and company standards.

• Release Procedures: Manage the release procedures for raw materials and packaging, ensuring that only materials meeting specifications are used in production.

7. Quality Assurance:

• Develop QA Programs: Develop and implement robust quality assurance programs to ensure consistent product quality throughout the manufacturing process.

• Monitor QA Activities: Continuously monitor quality assurance activities, ensuring compliance with established standards and identifying opportunities for improvement.

• Conduct QA Audits: Conduct regular quality assurance audits to ensure adherence to policies and procedures, implementing corrective actions as necessary to address any issues.

8. Quality Control:

• Develop QC Procedures: Develop and implement detailed quality control procedures to ensure that all products meet stringent quality and safety standards.

• Monitor QC Activities: Oversee quality control activities, ensuring accurate and timely testing of raw materials, in-process products, and finished goods.

• Manage QC Oversight: Ensure external QC labs are equipped with the necessary resources and technology to conduct thorough testing, analyzing results and addressing any deviations promptly.

9. CAPA and Root Cause Investigations:

• Develop CAPA Programs: Establish and implement Corrective and Preventive Action (CAPA) programs to address quality issues, ensuring timely resolution and continuous improvement.

• Root Cause Analysis: Lead thorough root cause investigations for any quality-related issues, ensuring comprehensive analysis and effective implementation of corrective actions.

• Continuous Monitoring: Continuously monitor the effectiveness of CAPA initiatives, making necessary adjustments to maintain high standards of quality and compliance.

10. Risk Management and Recall Procedures:

• Identify and Mitigate Risks: Identify potential quality risks and develop strategies to mitigate them, implementing robust risk management programs to proactively address issues.

• Investigate Quality Issues: Oversee the investigation of quality-related issues, ensuring thorough root cause analysis and implementation of corrective and preventive actions (CAPA).

• Recall Procedures: Develop and manage effective recall procedures to ensure swift and efficient action in the event of a product recall, minimizing impact and maintaining consumer trust.

11. Supplier Auditing and Inspection:

• Audit and Inspect Suppliers: Develop and implement supplier auditing and inspection programs to ensure that all suppliers meet the company’s quality and safety standards.

• Supplier Compliance: Regularly audit and inspect suppliers, ensuring they adhere to regulatory and company requirements, and address any compliance issues promptly.

• Supplier Relationship Management: Work closely with suppliers to ensure ongoing compliance and continuous improvement, fostering strong and collaborative relationships.

12. Cross-functional Collaboration:

• Collaborate with Departments: Work closely with R&D, production, supply chain, and other departments to ensure quality is integrated into all stages of product development and manufacturing.

• Provide Quality Input: Offer quality input during the design and implementation of new processes, equipment, and technologies, ensuring they meet quality standards.

• Liaison with External Bodies: Serve as a key liaison between the plant and external regulatory bodies, customers, and suppliers regarding quality matters, ensuring effective communication and collaboration.

13. Leadership and Team Development:

• Lead and Mentor Teams: Provide strong leadership and mentorship to the quality assurance and quality control teams, fostering a culture of continuous improvement and professional development.

• Recruitment and Training: Recruit, train, and retain top talent within the quality department, ensuring the team is equipped with the necessary skills and knowledge to maintain high-quality standards.

• Promote Quality Culture: Promote a proactive quality culture across all plant operations, encouraging employees to prioritize quality and safety in every aspect of their work.

14. Continuous Improvement:

• Drive Improvement Initiatives: Lead continuous improvement initiatives aimed at enhancing product quality, efficiency, and overall plant performance, using data-driven approaches to identify and implement improvements.

• Utilize Quality Metrics: Implement and utilize quality metrics and key performance indicators (KPIs) to monitor and improve quality processes, regularly reviewing performance and making necessary adjustments.

• Conduct Audits: Conduct regular internal audits and coordinate external audits to ensure compliance with quality standards, identifying areas for improvement and implementing corrective actions.

SUPERVISORY RESPONSIBILITIES:

Work with plant Quality Assurance Managers and Personnel, carrying out responsibilities in accordance with the organization’s policies, core values, and applicable laws. Responsibilities include interviewing, training, and rewarding employees; planning, assigning, and directing work; appraising performance; disciplining employees; addressing complaints and resolving problems.

QUALIFICATIONS:

To perform this job successfully, an individual must meet the following requirements:

• Bachelor’s degree in Food Science, Chemistry, Microbiology, Engineering, or a related field. Advanced degree preferred.

• Minimum of 10 years of experience in quality assurance, quality control, or regulatory compliance in the food manufacturing industry, with at least 5 years in a leadership role.. Strong preference for experience in Infant Nutrition (powdered milk production).

• In-depth knowledge of FDA regulations, cGMP, HACCP, SQF, GFSI, and other relevant quality and safety standards.

• Experience with FDA and US infant formula quality compliance and assurance in the US.  Full understanding of the requirement to compliantly manufacturing infant formula / packing for infant formula in the US with a strong track record of successful audits and production running.

• Proven experience developing and implementing Quality Management Systems in a manufacturing environment.

• Commitment to excellence and exacting standards.

• Excellent written and verbal communication skills.

• Strong organizational, problem-solving, and analytical skills.

• Strong interpersonal skills to deal effectively with diverse individuals at all organizational levels.

• Ability to make timely and sound decisions.

• Ability to negotiate win win outcomes under stressful conditions.

• Proven ability to use and evaluate measurement tools, including:

  • Hand tools (e.g., calipers, micrometers, linear scales).

  • Gauges (e.g., pins, thread, custom gauges).

  • Optical tools (e.g., comparators, profiles, microscopes).

  • Electronic measuring equipment (e.g., digital displays, output).

  • Weights, balances, and scales.

  • Hardness testing equipment (e.g., Brinell, Rockwell).

  • Surface plate methods and equipment.

  • Force measurement tools (e.g., torque wrenches, Chatillon).

  • Angle measurement tools (e.g., protractors, sine bars, angle blocks).

  • Gauge maintenance, handling, and storage.

ADDITIONAL SKILLS:

• Interpersonal Skills: Focuses on solving conflict, maintains confidentiality, listens without interrupting, keeps emotions under control, and remains open to new ideas.

• Teamwork: Balances team and individual responsibilities, exhibits objectivity, gives and welcomes feedback, and supports team success.

• Safety and Security: Observes safety procedures, reports unsafe conditions, and uses equipment properly.

• Dependability: Follows instructions, takes responsibility for actions, keeps commitments, and completes tasks on time or notifies appropriate personnel with alternatives.

EDUCATION AND/OR EXPERIENCE:

Bachelor’s degree in Food Science or a related field; minimum of 5 years’ experience in a manufacturing environment managing food and/or food packaging quality and safety programs, with experience in GFSI standards and regulatory requirements.

LANGUAGE SKILLS:

Ability to read and comprehend instructions, correspondence, and memos, and to write correspondence. Ability to present information effectively in one-on-one and small group situations.

MATHEMATICAL SKILLS:

Ability to calculate proportions, percentages, area, circumference, and volume, and apply concepts of basic algebra, geometry, and trigonometry.

REASONING ABILITY:

Ability to apply common sense to carry out instructions in written, oral, or diagram form and solve problems involving several concrete variables in standardized situations.

PHYSICAL DEMANDS:

The employee is regularly required to use hands and fingers to handle or feel, reach with hands and arms, and hear. Occasionally required to climb, balance, stoop, kneel, crouch, or crawl. Frequently required to stand, walk, and sit. Must lift and/or move up to 50 pounds. Specific vision abilities include close vision, distance vision, color vision, peripheral vision, depth perception, and ability to adjust focus.

WORK ENVIRONMENT:

The employee is exposed to moving mechanical parts and vibration. The noise level is usually loud to moderate.

NOTE:

This job description identifies the general nature and scope of work to be performed. Independent Can reserves the right to revise all or any part of this job description and to add or eliminate essential job functions at any time. Designation of any job duty as an essential function is not intended as an assurance or guarantee that a team member has any right to perform the particular job duty, except as required by Independent Can. This job description is subject to change based on the needs of the position and/or the Company.

I acknowledge that I have read and understand the above job description/expectations in its entirety and am capable of performing all of the stated requirements.