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. Powered by JazzHR