Supporting a positive quality improvement culture, upheld by effective quality/food safety compliance and risk management frameworks.
Ensuring that a quality & food safety management system remains compliant with relevant standards and regulations.
Identifying and addressing quality & food safety risks through assessment, control, communication, and analysis.
Seeks continuous self-improvement through education and experience.
Full understanding of the Quality & Food Safety Management System to assist in training others.
Ensure regulatory, customer and quality standard compliance for existing and new processes and product applications.
Responsible for creating, updating, and maintaining quality and food safety system documentation.
Responsible for quality & food safety risk management (HACCP, TACCP, VACCP, etc.).
Member of the Food Safety & HACCP Team Lead and assist internal audits.
Assist external audits (customer, regulatory, Kosher, Halal etc.).
Attend quality meetings and provide relevant updates.
Resolve problems and set deadlines to ensure timely completion of work.
Develop annual goals and objectives for department and provide quarterly feedback.
Work with corporate quality and regulatory members.
Coach and train team members to improve work related skills.
Prepare reports to monitor and manage departmental objectives.
Build and maintain a positive work environment.
Seek out and implement improvement ideas with regards to quality management system.

College Diploma/Degree in food safety/quality related field or 7+ years’ experience in food safety/quality related work or 4+ years' FDA specific experience
Certified training preferred: Lead Auditor, PCHF, HACCP & Food Defense
Direct experience supporting FDA inspections, third party GMP audits, and regulatory remediation programs.
Experience in API intermediates, fermentation based processes, or complex manufacturing environments.
Background in change management and quality transformation initiatives.
Excellent oral, written and computer communication skills.
Excellent networking skills and professional communication.
Ability to transfer compliance knowledge to practical applications.
Ability to lead and support quality activities.
Applies critical thinking to daily tasks.
Strong knowledge of FDA food and feed GMP’s.
Knowledge of FDA pharmaceutical GMP’s.
Ability to effectively work and influence others.
Committed to delivering business impactful solutions.
Strong practical risk assessment and management skills with an ability to work under pressure.
A strong team player with the ability to maintain a level of flexibility to support the broader team.
Passionate about delivering consistent, high-quality products to our consumers and customers that are safe and fully comply with all relevant regulations.

Senior Quality Assurance Regulatory Specialist

Key skills