Document Control

Sisel International, LLC; Springville (UT); On-site; USD 45,000 - 65,000; Full time

Job summary

Sisel International, LLC is seeking a Document Control Specialist in Utah to maintain strict cGMP documentation, specs, and training records. You will review SOPs, manage records, and support regulatory audits to ensure product safety and compliance.

Ideal candidates have 1–2 years in production/quality, strong MS Office skills, and attention to detail in a fast-paced environment.

Qualifications

• High school diploma or equivalent; 1–2 years in production/quality preferred.
• Nutraceutical or pharmaceutical environment experience preferred.
• Strong document control and regulatory awareness.

Responsibilities

• Review and approve SOPs, policies and cGMP documents.
• Ensure projects conform to company policies and procedures.
• Review Master & Batch Records, Test Records, Supplier Specifications for regulatory compliance.
• Review and approve packaging records and finished product release documents.
• Maintain specifications control, filings, and change history.
• Distribute quality system documents for review and authorization.
• Control and distribute documents to internal contacts, suppliers, and contract manufacturers.
• Maintain systems requirements, formats, and procedures for controlled documents.
• Conduct periodic audits of SOPs, records, and report results for updates.
• Oversee and maintain retain sample program per FDA CGMP.
• Train personnel in specifications and SOPs; update training database.
• Participate in regulatory and third-party audits.
• Cross-train in other Quality functions.
• Other duties as assigned.

Skills

Team collaboration

Attention to detail

Office software proficiency

English proficiency

Adaptability

Documentation editing

Regulatory awareness

Education

High school diploma or equivalent

Tools

Microsoft Office

Oracle

Job description

POSITION PURPOSE AND SCOPE:

The Document Control Specialist is responsible for supporting and maintaining the company’s compliance with applicable quality standards. This includes oversight of cGMP practices, quality systems, documentation, product labeling. This role is critical in ensuring products are safe, effective, and compliant with all regulatory requirements.

ESSENTIAL RESPONSIBILITIES:

• Review and approve all SOP’s, policies and cGMP documents.
• ensures all projects, initiatives and processes are in conformance with company established policies and procedures.
• Review all Master Manufacturing Records, Batch Records, Test Records, and Supplier Specifications to ensure they meet federal or 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 all documents and specifications to proper internal contacts, suppliers, and contract manufacturers.
• Maintain the systems requirements, formats, and procedures to produce, approve, release, control and archive controlled Documents.
• Conduct periodic audits of SOPs, record, 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 the use of specifications and SOPs.
• Update training database with employee training based on training records submitted to document control. Files and maintains the training files. Sends out companywide training notifications.
• Participate in regulatory and third-party audits.
• Cross train in other Quality related functions.
• Any other duties and/or responsibilities as assigned.

EDUCATION EXPERIENCE:

High school diploma or equivalent plus 1-2 years’ work experience in production/quality with nutraceutical or pharmaceutical environment preferred.

SKILLS AND ABILITIES:

• Must be able to work well with others especially when editing or revising their documents.
• Must be willing to perform repetitious tasks such as updating forms, filling logs, copying, and scanning documents.
• Proficiency in Microsoft Office applications is required. Oracle experience a plus, but not required.
• Must be flexible and adaptable to a fast pace, changing environment.
• Possess a positive attitude; be an excellent team player.
• Familiar with Federal and State regulation concerning dietary supplement requirements.
• Good Organization Skills and extremely detail oriented.
• Ability to work under pressure, plan personal workload effectively and delegate.
• The ability read, speak and understand English.

PHYSICAL DEMANDS:

Positions is required to sit, stand and walk, stoop, bend, reach and kneel. Lift at least 30lbs plus on occasion.

WORK ENVIRONMENT:

Noise, dust, lighting, temperature, and physical/ergonomic hazards are typically those usually found in an office environment.