Quality Specialist

NO EXTERNAL RECRUITERS PLEASE

**No Sponsorship/Transfer Available**

Company Summary:

The Quality Compliance Specialist is responsible for supporting and maintaining the companys 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 Youll Do:

• Applied knowledge of US FDA regulatory matters Parts/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 3^rd 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 CertificationsLicenses 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 Youll Bring:

• Bachelors 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 3^rd party compliance standards (Organic Kosher Halal Non-GMO)
• Knowledge of local state and federal regulations applicable to the plants 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 $65000. to $70000. The compensation offered may vary depending on the candidates 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 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: more information about the categories of personal information we collect from you and how we use sell and share that information please see our Privacy Notice for California Contractors and Privacy Notice for California Employees.