Quality Manager, OFC

Quality Manager – Gummy Dietary Supplement

For over 60 years, Meri Cal 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 products—from 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 Meri Cal, we don't just meet expectations—we 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 You'll Do:

• Responsible for ensuring Good Manufacturing Practices 21 CFR Part 111 (dietary supplements), Part
  117 (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, training, scheduling, 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 Meri Cal's 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 site's 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…