Sr. Specialist, Quality Assurance Regulatory

Quality & Food Safety Management Position

The position is responsible for supporting a positive quality improvement culture, upheld by effective quality/food safety compliance and risk management frameworks. Under minimal supervision, the position holder ensures that a quality & food safety management system remains compliant with relevant standards and regulations. Quality & food safety risks will be identified and addressed by the appointee through assessment, control, communication, and analysis.

Qualifications:

EDUCATION, CERTIFICATIONS AND EXPERIENCE:

• 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

PREFERRED QUALIFICATIONS: • 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.

KNOWLEDGE, SKILLS AND ABILITIES:

• 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.

Working Conditions / Physical Requirements:

WORKING CONDITIONS:

Fast paced bio-chemical/chemical manufacturing environment working inside and outside. This position may perform activities in an environment that contains hazardous elements and requires safety awareness and adherence to all safety policies and guidelines. Work must be performed in a safe manner for personal protection and for the protection of other team members. All safety procedures, procedures described in SOPs, JHAs, and support the compliance of applicable ISO standards in all functional areas must be followed, enforced, and strictly complied with.

PHYSICAL REQUIREMENTS:

Sitting or standing, repetitive use of hands and arms, and eye/hand coordination for 6+ hours a day. Walking required, usually < 1-2 hours a day. The position may require lifting, up to 50 lbs., on occasion. Occasional bending, reaching overhead, crouching, balancing, pushing, or pulling. Position holder may be required to drive. Some travel required, < 10%.

Responsibilities:

Training & Development

• Seeks continuous self-improvement through education and experience.
• Full understanding of the Quality & Food Safety Management System to assist in training others.

Food Safety/Quality Compliance & Risk Management

• 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.

General Responsibilities

• 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.
• Adherence to all company quality, safety, and environmental policies and takes immediate corrective action when an issue arises.
• Any other duties and/or training as assigned by the Department Manager.

Continuous Improvement & Collaboration

• Actively collaborate with other departments within the company to accomplish tasks/goals.
• Continually strive for increasing processing efficiencies.
• Support 5S activities.

Salary Range: 75,000-80,000

EEO Statement: Ajinomoto is an Equal Opportunity Employer and does not discriminate on the basis of race, religion, color, sex, age, physical or mental disability, national origin, veteran status or any other basis protected by state, federal, or local law. All employment is decided on the basis of qualifications, merit, and business need.