Quality Process Compliance Specialist

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:

The Quality Process Compliance Specialist will ensure that the facilities are operating per cGMP requirements and internal Merical procedures. Ensuring records prepared by manufacturing Quality Control Maintenance Warehouse etc. meets all established criteria completed in real time while following Good Documentation Practices. Ensure quality assurance programs are maintained in accordance with pertinent regulatory requirements and internal SOPs in the performance of the duties of this position. It is also responsible for reporting KPI performing internal audits customer complaint investigations and reports necessary to support these programs. This role will be critical in performing or coordinating the updating of procedures process documentation and collaborating with multiple internal departments to ensure regulatory compliance is maintained or exceeded within Merical. The quality process compliance specialist should develop implement and administer required certification programs requirements internally with the internal stakeholders i.e.: R&D and Procurement.

What Youll Do:

• Applied knowledge of Parts/211 of the FDA Code of Federal Regulations (e.g. HACCP and Risk-Based Preventative Controls for Human Food FSMA FSVP cGMP) and regulatory matters in other jurisdictions (e.g. Health Canada).
• Working with internal department heads leaders and floor personnel to ensure compliance with Regulatory 3^rd party and Merical requirements driving process and documentation improvements to ensure requirements are met or exceeded across multiple sites.
• Leads product complaint investigations responds to customer and ensure closure <30 days tracks and trends. CAPAs and SCARS review process and initiate. Maintain all logs related to these processes.
• Review calibration results and document the review support maintenance with updating the master calibration list in the maintenance software program.
• Supports FDA Recall/Withdrawals: Research Submission Monthly Effectiveness checks updates to FDA CAPA and Customers.
• Assist in coordinating with production and planning schedules to ensure batch records are issued to the floor prior to production needs.
• Conduct internal audits to verify compliance with regulatory cGMP food safety and company requirements; monitor established programs and collaborate cross-functionally to implement improvements as needed.
• Perform required training of personnel on procedures processes regulations corrective actions and new procedures.
• Support QC Inspectors on manufacturing and packaging as needed.
• Write edit and update company policies and procedures.
• Supports and participates in inspections and audits from State Federal 3rd party certifiers and customer inspection.
• Monitoring and reporting of Quality KPIs.
• Analyze data and provide solutions to improve quality and efficiency.
• Perform troubleshooting and investigation of process non-compliances.
• Initiates documents routes and approves non-conformances deviations CAPAs and change control documents.
• Develop or update validation/verification protocols.
• Works to complete annual reviews of HACCP Program audit findings update flow diagrams in Visio and document reviews via summary Reports.
• Review and approve the supplier qualification package prior to final supplier approval and conduct periodic reviews of suppliers considered high-risks.
• Prioritize tasks in a high-pressure and deadline-driven environment.
• Completes requests from Contract Customers for: Pre-Audit questionnaire completion GMP Certs Licenses and Registrations etc.
• Works periodically on the manufacturing floor to support in-process inspection AQL and sampling.
• Oversee and coordinate facility and equipment change controls assisting in equipment qualification reporting and execution.
• Author and review quality report; Annual product reviews quality risk assessments impact assessments.
• Performs other duties as assigned.

What Youll Bring:

• Bachelors Degree in Food Science or equivalent is required.
• Minimum of 8 years in FDA Regulated Manufacturing environment.
• 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(Dietary Supplements) 117 (Human Food) or 210 and 211 (Drug Manufacturing).
• The specialist must have a broad knowledge of 21 CFR Part 111 Current Good Manufacturing Practice
• PCQI Certified a plus.
• Expertise with 3^rd party compliance certification bodies/standards (Organic Kosher Halal Non-GMO) a plus.
• 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 of dietary supplement manufacturing and an understanding of HACCP are desirable.
• Demonstrates flexibility when confronted with urgent situations priority changes or new assignments.
• Accept other additional assignments and responsibilities to support the business.
• Ability to work independently and manage time effectively and/or work cross functionally with other departments.
• Self-driven & motivated.
• The specialist must have strong leadership and communication skills and have the ability to tackle problems as they arise with limited 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 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 $72000.-$80000. Thecompensation 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.