Document Control

Sisel International, LLC • Springville, UT

4d

About The Position

The Document Control Specialist supports and maintains the company’s compliance with applicable quality standards, including oversight of cGMP practices, quality systems, documentation, and product labeling. The role helps ensure products are safe, effective, and compliant with regulatory requirements.

The position maintains controlled-document systems and records, reviews quality and manufacturing documentation, supports employee training records, and participates in regulatory and third-party audits. The specialist also cross-trains in other Quality functions and performs other duties as assigned.

Requirements

• High school diploma or equivalent.
• Proficiency in Microsoft Office applications.
• Ability to work well with others, particularly when editing or revising their documents.
• Willingness to perform repetitive tasks such as updating forms, filling logs, copying, and scanning documents.
• Flexibility and adaptability in a fast-paced, changing environment.
• Positive attitude and ability to work as a team player.
• Familiarity with federal and state regulations concerning dietary supplement requirements.
• Good organizational skills and strong attention to detail.
• Ability to work under pressure, plan personal workload effectively, and delegate.
• Ability to read, speak, and understand English.
• Ability to sit, stand, walk, stoop, bend, reach, and kneel, and to lift at least 30 pounds on occasion.

Nice To Haves

• One to two years of work experience in production or quality in a nutraceutical or pharmaceutical environment.
• Oracle experience.

Responsibilities

• Review and approve SOPs, policies, and cGMP documents.
• Ensure projects, initiatives, and processes conform to company policies and procedures.
• Review Master Manufacturing Records, Batch Records, Test Records, and Supplier Specifications for compliance with federal and state regulations.
• Review and approve packaging records and finished-product release documentation.
• Maintain specifications control, filings, and change history.
• Distribute quality-system documents for review and authorization as required.
• Control and distribute documents and specifications to internal contacts, suppliers, and contract manufacturers.
• Maintain the requirements, formats, and procedures for producing, approving, releasing, controlling, and archiving controlled documents.
• Conduct periodic audits of SOPs and records, and report results to ensure alignment with updated processes and regulatory changes.
• Oversee and maintain the retain-sample program in accordance with FDA CGMP and company requirements.
• Train and assist personnel in using specifications and SOPs.
• Update the training database based on submitted training records, maintain training files, and send companywide training notifications.
• Participate in regulatory and third-party audits.
• Cross-train in other Quality-related functions.
• Perform other duties and responsibilities as assigned.

What This Job Offers

• Job Type: Full-time
• Education Level: High school or GED