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MeriCal®

QA Document Control/Release

MeriCal®, Orange, California, United States, 92613

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QA Document Control/Release

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MeriCal®

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 products—from research and development to finished goods. 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 don’t just meet expectations—we exceed them, every time.

The Opportunity The Document Control Specialist is detail‑oriented and computer proficient. The role involves maintaining and managing all controlled documents within the Quality Management System (QMS) to ensure compliance with FDA regulations under 21 CFR Parts 111 (Dietary Supplements), 117 (Food Safety), and 210‑211 (Drug GMPs). The specialist will be a key member of the Quality Assurance team, leading change control operations and managing documents that support our cGMP quality operations.

What You’ll Do

Maintain and manage controlled documents including SOPs, CAPAs, deviation records, batch records, specifications, controlled forms, calibration certificates, training records, logbooks, and qualification records.

Maintain a current master index of all controlled documents and ensure distribution lists are up to date.

Process document change requests, revisions, approvals, and archival in accordance with internal SOPs.

Maintain both paper and electronic records, and oversee the transition to electronic record‑keeping.

Ensure proper labeling, version control, and protection of all documents.

Initiate change control procedures as needed and coordinate with QA, R&D, Regulatory, Manufacturing, and other departments to ensure timely review and release of documents.

Act as system administrator and subject‑matter expert for the electronic document control quality management system.

Conduct periodic document audits to ensure accuracy, completeness, and regulatory compliance.

Train staff on document control procedures and the change control program.

Support internal and external audits by providing necessary documentation in a timely, organized manner.

Assist in continuous improvement initiatives related to document control and quality systems.

Conduct new‑hire cGMP onboarding training, create evaluation tests, issue job‑specific curricula, and schedule and deliver annual training.

Support and train all employees on quality issues to assure compliance and track training progress via a training matrix.

Help assist with QA functions related to customer documentation requests.

Manage KPI metrics and review calibration results, maintaining the master calibration list.

Assist in coordinating production operations to ensure batch records are issued to the floor before production.

Assist in supplier qualification programs and quality assurance operations related to customer and regulatory audits.

Perform other duties as assigned.

What You’ll Bring

Minimum high‑school diploma, bachelor’s degree preferred.

Minimum 3+ years of experience in quality in an industry regulated by 21 CFR Parts 111, 117, 210/211 (Part 111 highly preferred).

Strong project‑management skills, experience leading cross‑functional teams, and the ability to handle multiple projects simultaneously.

Excellent verbal and written communication and ability to understand instructions in English.

Ability to work independently with limited supervision.

Advanced proficiency with Microsoft Office Suite and other related software.

Familiar with ERP systems (SAGE) and quality management systems such as ETQ Reliance, Trackwise, MasterControl.

The Perks

No‑cost vision insurance; employer‑paid life insurance; paid company holidays; generous paid time off; sick leave; employee assistance program; 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.

Compensation Base pay range: $27.00/hr - $34.00/hr. The compensation offered may vary depending on the candidate’s geographic region, job‑related knowledge, skills, and/or education.

Equal Opportunity Employer 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 recruiting@merical.com if you need an accommodation due to a disability to complete an application, job interview, and/or otherwise participate in the hiring process.

MeriCal uses E-Verify to confirm authorization to work in the United States. For more information on E-Verify, please visit https://www.e-verify.gov/employees.

For 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.

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