Quality Manager, OFC

Company Summary:

For over 60 years MeriCal has been at the forefront of innovation in the dietary supplement industry delivering custom manufacturing and packaging solutions with passion and precision. With state-of-the-art facilities in Southern California and Ogden UT we transform ideas into high-quality productsfrom research and development to the finished products. Our team with over 30 years of combined experience is dedicated to crafting exceptional gummies probiotics tablets capsules chewables and powders using clinically backed ingredients. At MeriCal we dont just meet expectationswe exceed them every time. Join us and be part of a dynamic forward-thinking team shaping the future of nutrition!

The Opportunity:

Under the direction of the Director of Quality & Compliance the Quality Manager Gummy Dietary Supplement is responsible for ensuring compliance with the provisions of the FDA 21 CFR Part 111 food safety policies and ensures that day-to-day production matches our established standards of quality. The Quality Manager Gummy position is responsible for monitoring and maintaining key indicators of product quality and safety through inspection testing and communication and is responsible for notifying of any deviations in quality processes. This position plays an integral role in aligning operations with corporate quality policy such as preparation for 3rd party audit ingredient control adherence to Dietary Supplement cGMP document control traceability non-conformance reports etc. The Quality Manager will work closely with R&D receiving production packaging and customer service to ensure all production materials are inspected approved reviewed and authorized prior to Quality product release. This role leads the Quality Assurance (QA) and Quality Control (QC) teams and ensures that all dietary supplement products are manufactured packaged tested and released according to internal quality standards and external regulatory requirements. The Quality Manager Gummy Dietary Supplement is responsible for supervising Quality staff and reports directly to the Director of Quality & Compliance.

What Youll Do:

• Responsible for ensuring Good Manufacturing Practices 21 CFR Part 111 (dietary supplements) Part117 (food safety) and Part 210/211 (if applicable) & Food Safety policies are adhered to throughout the facility.
• Responsible for in-line inspections within manufacturing and packaging areas across 3 shifts towards established customer specifications.
• Lead and manage the Quality Assurance and Quality Control departments including hiring trainingscheduling and performance management of quality personnel.
• Communicating and alerting management of any unusual occurrence and any pertinent issues that affect production & packaging.
• Develop and maintain SOPs to support compliance with cGMP and regulatory standards.
• Responsible for product monitoring towards maintaining calibrating and troubleshooting in process testing ATP pH Water Activity Brix etc. towards established objective measurements.
• Responsible for sampling the product components following MeriCals SOP for proper Sampling Technique locating corresponding production records for lots to be sampled and transferring sampled lots for sample retentions customer requests laboratory testing etc.
• Participates with generating Manufacturing Batch release documentation reviewing batch record documentation authorization for product packaging release and effectively communicating product status to operations.
• Oversee and continuously improve the sites Quality Management System (QMS) including change control CAPA deviations Non-Conformances QA Holds complaints product investigations audits and documentation control.
• Maintain a safe working environment by adhering to requirements by EHS OSHA and all government food safety sanitation and quality regulations.
• Participate in and lead internal and external audits (FDA certification bodies customer and third-party).
• Collaborate with cross-functional teams (Operations R&D Regulatory Engineering) to address quality issues and implement preventive actions.
• Monitor key quality metrics and trends providing regular reports to senior leadership.
• Ensure employee training and qualification programs are developed executed and maintained.
• Promote a strong quality culture focused on accountability data integrity and continuous improvement.
• Responsible for performing additional miscellaneous duties as assigned.

What Youll Bring:

• Minimum 5 years experience working in Quality environment for dietary supplement (preferred) confectionary (preferred) and / or food & beverage manufacturing
• Must be familiar with cGMP FDA requirements and regulations as they pertain to Quality in a dietary supplement manufacturing & packaging environment CFR 111/117 and 210/211 cGMP HACCP and FSMA.
• Experience managing teams and implementing quality systems.
• Proven experience with internal and external audits.
• Must be computer literate and familiar with Microsoft Word Excel and other software necessary to work in the Quality Assurance Department.
• Attention to detail and ability to adapt to change in a fast-paced environment.
• Must be able to read write and effectively communicate in English.
• Ability to effectively communicate in Spanish is a plus

Education Requirements:

• BS / BA degree in Engineering Chemistry Biology or Food Science preferred.
• Relevant coursework and / or experience in lieu of education may be considered.
• 5 years of experience in Dietary Supplements / food manufacturing Quality Assurance role.

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 are 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 $00. 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.