Document Control

Sisel International

Job Location:

Springville, UT - USA

Monthly Salary: Not Disclosed

Posted on: 1 hour ago

Vacancies: 1 Vacancy

Job Summary

POSITION PURPOSE AND SCOPE:
The Document Control Specialist is responsible for supporting and maintaining the companys 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 SOPs policies and cGMP documents.
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.

Required Experience:

Junior IC

POSITION PURPOSE AND SCOPE:The Document Control Specialist is responsible for supporting and maintaining the companys compliance with applicable quality standards. This includes oversight of cGMP practices quality systems documentation product labeling. This role is critical in ensuring products are...

Review and approve all SOPs policies and cGMP documents.
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.