Quality Compliance Specialist
MeriCal LLC - orange, CA
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NO EXTERNAL RECRUITERS PLEASE **No Sponsorship/Transfer Available** Job Description: Are you a compliance expert with a passion for quality assurance? Do you thrive on ensuring products meet the highest regulatory standards while working cross-functionally with innovative teams? MeriCal is looking for a dynamic and detail-oriented Quality Compliance Specialist to join our team and help us maintain excellence across our product certification programs. If you're ready to play a key role in ensuring our dietary supplements meet the latest regulatory standards, this is the perfect opportunity for you! About MeriCal: MeriCal is a leading private-label and contract manufacturer of dietary supplements with over 90 years of industry expertise. Our commitment to innovation and quality has established us as a trusted partner in the health and wellness space. Our culture emphasizes collaboration, safety, and continuous improvement, offering an excellent environment to grow your career. What It's Like to Work Here: At MeriCal, we foster a team-oriented, fast-paced environment where employees work together to achieve excellence. Our team members share a positive attitude, problem-solving skills, and a dedication to high-quality production. You'll be part of a collaborative workforce focused on innovation, safety, and the pursuit of wellness. About the Role: The Quality Compliance Specialist is pivotal in managing MeriCal's product certification programs. You'll be responsible for ensuring compliance with Kosher, Halal, Non-GMO, Organic, and other product standards. You'll manage regulatory requirements across various internal teams, ensuring we meet FDA regulations and uphold product safety. This role requires a strong understanding of 21 CFR Part 117 and other key regulatory standards. You'll also play an active role in inspections, audits, and mock recalls. Manage all 3rd party product certification programs (Kosher, Halal, Non-GMO, Organic, Gluten-free, Vegan) and ensure compliance with changing regulations. Work cross-functionally with R&D, Technical Services, Planning, and QC teams to maintain adherence to federal and policy regulations. Coordinate with production teams to ensure all batch records are ready for production. Lead mock recalls, trace exercises, and manage quality compliance initiatives including Change Controls, Deviations, Non-conformances, and CAPAs. Conduct internal audits and inspections to maintain regulatory compliance across the facility. Oversee the Foreign Supplier Verification Program (FSVP), ensuring supplier qualification packages meet all necessary standards. Review product formulas and manufacturing processes for compliance with FDA and 3rd party regulations. Support audit readiness for certifications such as Organic, Kosher, and Halal. Act as the point of contact for state, federal, and customer inspections. About You: You are a compliance expert who thrives on collaboration and problem-solving. You have a strong understanding of FDA regulations, third-party certifications, and quality management systems. Your organizational skills and ability to communicate across departments set you apart. You're proactive, motivated, and always up for a challenge. Qualifications: Bachelor's Degree in Food Science or a related field. Minimum of 8 years of experience in an FDA-regulated manufacturing environment. Working knowledge of FDA 21 CFR Parts 111 and 117 (Dietary Supplements) or 210 and 211 (Drug Manufacturing). PCQI Certified, with expertise in 3rd party compliance standards (Organic, Kosher, Halal, Non-GMO). Strong proficiency in MS Office (Word, Excel, PowerPoint, Visio, Teams) and Adobe Acrobat. Excellent communication and organizational skills, with the ability to manage multiple priorities. Experience with HACCP, internal auditing, and supplier quality management is highly desirable. Ability to work independently and lead quality initiatives with minimal supervision. The Perks : At MeriCal, we value our team members and offer exceptional benefits: No cost (yes, you read that right!) vision insurance, employer-paid life insurance, paid company holidays, generous paid time off benefits and sick time, employee assistance program, and a comprehensive wellness program Affordable medical and dental insurance plans that fit the needs of you and your dependents Outstanding supplemental benefits, including Accident, Critical Illness, Hospitalization indemnity plans, and pet insurance Matching 401k plan and more! Join MeriCal and contribute to producing high-quality gummy supplements in an environment that values safety, collaboration, and excellence. Click the 'apply' button to be a part of our innovative team! The salary range stated here is the low and high end of the pay range for this position. It does not necessarily reflect actual compensation that may be earned and does not promise any specific pay for any specific employee. Actual starting rate of pay may vary based on factors that include, but are not limited to, position offered, location, work education, training, and experience. MeriCal uses E-Verify to confirm authorization to work in the United States. For more information on E-Verify, please visit the following website: 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.
Created: 2024-10-15