Sr. Specialist, Quality Assurance Regulatory
Indexed description
We do not use AI to screen applications. Applications and resumes of qualified applicants are reviewed by a real person because we value your time and believe each qualified applicant deserves thoughtful, human consideration. It’s an old‑fashioned approach—done with purpose.
Our people are the key ingredient to our success. We offer a collaborative, innovative environment where you can grow your career and make an impact on global food and health solutions.
We provide a comprehensive and competitive total rewards package, including
- Competitive Pay and Annual Bonus Opportunity
- 401(k) with Company Contributions
- Medical, Dental, and Vision — Effective Day 1
- Paid Time Off, Company Holidays, and Floating Holidays
- Paid Parental Leave
- Wellness Programs and Yearly Wellness Reimbursement
- Work Flexibility
- Company-Paid Life and Disability Insurance
- Employee Assistance Program (EAP)
- Tuition Reimbursement Opportunities
- Career Growth and Development within a Global Organization
- Company-Provided Mental Health and Caregiving support
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
- 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.
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%.
Training & Development
- 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.).
- 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.
- 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.
- Actively collaborate with other departments within the company to accomplish tasks/goals.
- Continually strive for increasing processing efficiencies.
- Support 5S activities.
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.
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