Job Description

NO EXTERNAL RECRUITERS  PLEASE

  **No Sponsorship/Transfer Available**

Company Summary:

The Quality Compliance Specialist is responsible for supporting and maintaining the company’s Quality Management System to ensure compliance with federal, state, and third-party regulatory requirements. This role oversees product certification programs (e.g., Kosher, Halal, Organic, Non-GMO, Gluten-Free, Vegan), ensures regulatory compliance with FDA standards including 21 CFR Part 117, and partners cross-functionally with R&D, Procurement, and Quality teams to maintain accurate documentation and certification status. The specialist exercises independent judgment to support audit readiness, regulatory adherence, and continuous quality improvement initiatives.

What You’ll Do:

• Applied knowledge of US FDA regulatory matters Parts 111, 117, 210/211 of the FDA Code of Federal Regulations (e.g., FSMA, FSVP, cGMP), and regulatory matters in other jurisdictions (e.g., Health Canada). 
• Single Point of Contact (SPOC) for certification programs; you will development, implementation, and manage the administration of all 3rd Party product certification programs i.e.: Kosher, Halal, Non-GMO, Organic, Gluten-free, Vegan, etc.
• Works cross functionally with R&D, Technical Services, Planning and QC teams to review formulas and manufacturing processes that need to be compliant with Federal and policy regulations (FDA), other 3rd party regulatory entities.
• Coordinates with production and planning schedules to ensure batch records are issued to the floor prior to production need.
• Facilitates Material Review Board (MRB), and Quality Management Reviews meetings.
• Leads Mock recalls and trace exercises.
• Assists in the management of Change Controls, Deviations, Non-conformances, and CAPAs for Quality.
• Participate in inspections and audits from State, Federal, 3rd party certifiers, and customer inspection
• Support audit readiness i.e.: Organic, Kosher, Halal and others as required to ensure compliance.
• Conduct internal audits to ensure compliance is maintained within the organization by following up with implemented programs (GMPs, Good Hygiene Practices, HACCP, Allergen. Control, Cleaning and Sanitation, Pest Control, Equipment Calibration, Organic Certification, etc.) to ensure compliance by all employees and other personnel in the manufacturing facility.
• Work with global purchasing department to establish quality requirements for external supplier.
• Completes requests from Contract Customers for: Pre-Audit questionnaire completion, GMP Certifications, Licenses and Registrations etc.
• Responsible for the company licenses and permits i.e.: Federal, State, and City registrations.
• Works periodically on the manufacturing floor to support in-process inspection, AQL and sampling.

What You’ll Bring:

• Bachelor’s degree in food science or equivalent is required.
• Minimum of 3 years’ experience in food and dietary supplement, labeling, regulatory, manufacturing, retail and/or similar experience.
• Critical thinking abilities with self-motivation to dive into details as needed  
• Must have working knowledge of industry regulatory compliance standards FDA 21 CFR Parts 111, 117 (Dietary Supplements) or 210 and 211 (Drug Manufacturing)
• PCQI Certified
• Prefer expertise 3rd party compliance standards (Organic, Kosher, Halal, Non-GMO)
• Knowledge of local, state, and federal regulations applicable to the plant’s business is desired
• Must be proficient in MS Office (Word, Excel, PowerPoint, Visio, MS Teams), and Adobe Acrobat
• Must be organized, meet deadlines, and tasks, prioritizing efficiently and creating a workflow for the process  
• Excellent communication skills: Must read, write, and understand English to communicate at various organizational levels
• Internal Auditing and an understanding of HACCP are desirable               
• Demonstrates flexibility when confronted with emergencies, priority changes, or new assignments
• Accept other additional assignments and responsibilities to support the business
• Ability to work independently and manage time effectively
• Ability to work without direct supervision

The Perks:

• No-cost vision insurance (yes, you read that right!), employer-paid life insurance, paid company holidays, generous paid time off, sick leave, employee assistance program, and a comprehensive wellness program. 
• Affordable medical and dental insurance plans tailored for you and your dependents.
• Exceptional supplemental benefits, including Accident, Critical Illness, Hospitalization indemnity plans, and pet insurance.
• 401(k) matching plan and more!

 A reasonable estimate of the current base pay range for this position is $65,000. to $70,000. The compensation offered may vary depending on the candidate’s geographic region, job-related knowledge, skills, and/or education.

MeriCal is an equal opportunity employer and is committed to providing a workplace that is inclusive and free of discrimination and harassment. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability status, protected veteran status, or any other characteristic protected by law. We encourage individuals of all backgrounds to apply. We believe in creating a diverse and inclusive workplace where all employees feel valued and respected, and where differences are embraced as strengths. We are dedicated to fostering an environment that promotes equality and celebrates diversity.
 
Qualified applicants with disabilities may be entitled to reasonable accommodation under the terms of the Americans with Disabilities Act and/or certain state or local laws. Please contact [email protected] if you need an accommodation due to a disability to complete an application, job interview, and/or to otherwise participate in the hiring process. This email does not respond to non-accommodations related requests.
 
MeriCal uses E-Verify to confirm authorization to work in the United States. For more information on E-Verify, please visit the following website: https://www.e-verify.gov/employees
 
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