Document Control Associate

Job Summary:

The Document Control Associate supports the Quality department by assisting with the organization, maintenance, and distribution of controlled documents. This role ensures that all documentation related to manufacturing, quality, and operations is accurate, current, and compliant with company Standard Operating Procedures (SOPs) and regulatory requirements. The Document Control Associate works closely with the Document Control Supervisor and other departments to help maintain efficient and compliant documentation systems.

 Job Duties & Responsibilities:

• Assist in the creation, revision, and distribution of controlled documents such as Master Manufacturing Records, Finished Product Specifications and Raw Material Specifications. Support the processing of document change requests, deviation records, and approval tracking.
• Help maintain organized filing systems (both electronic and physical) for batch records, and other quality documents.
• Aid in issuing batch records as directed by the Document Control Supervisor, ensuring traceability and compliance.
• Assist in the review and closeout of batch records to verify compliance with Good Documentation Practices (GDP) and confirm products were manufactured according to specification.Assist in maintaining accurate records of document history, approvals, and version control.
• Enter and update data in Quality Management systems and databases under supervision.
• Coordinate with Procurement, R&D, and Customer Account Management teams to gather and verify information needed for Bills of Materials and Manufacturing Records.
• Help ensure that documentation is accessible to authorized personnel and archived according to company policies.
• Support internal and external audits by preparing and organizing requested documentation.
• Assist in managing label inventory and revision changes.
• Perform other duties as assigned to support the Quality team.

 Job Requirements

• Education: High school diploma or GED required; some college coursework in business, science, or quality management preferred.
• Experience: 1 year of administrative, clerical, or document control experience in a regulated manufacturing environment preferred.
• Proficiency in Microsoft Office (Word, Excel, Outlook) required.
• Strong attention to detail and accuracy.
• Ability to follow established procedures and maintain confidentiality.
• Basic mathematical skills (addition, subtraction, multiplication, division, percentages).
• Strong organizational and communication skills.
• Ability to work both independently and collaboratively in a team environment.

 Physical Requirements:

• Prolonged periods sitting at a desk and working on a computer.
• Occasional lifting of files or boxes up to 25 lbs.
• Ability to maintain focus and attention to detail in a fast-paced environment.

 Note: Employees may be crossed trained in any or all areas.  At any point in time an employee may be asked by the manager to perform responsibilities outside the areas indicated above.

The SOPs necessary to perform the above responsibilities are listed on the Personal Training Record developed for this position.