Document Control

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.

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