Document Control Specialist

About the role

A Document Control Specialist is responsible for maintaining organized and updated documents related to ISO compliance. This role coordinates and performs day-to-day activities of Quality Systems, including supplier qualification, deviation management, change management, and document control. The specialist ensures TS Conductor operates in accordance with current Good Manufacturing Practices, ISO 9001:2015, and other ISO standards.

Responsibilities

• Manage the intake, handling, and storage of documents.
• Develop and implement processes for document control.
• Ensure all documentation meets formal requirements and standards.
• Review and update documents as necessary.
• Track and manage versions of documents.
• Retrieve files as needed by company staff.
• Secure backup and storage of documents, ensuring accessibility and discoverability.
• Collaborate with departments to complete deviation investigations, CARs, change controls, and NCRs.
• Maintain the supplier qualification program, including evaluation of supplier self-audit questionnaires, assisting in audits, tracking supplier performance, and establishing Quality Agreements/Clauses.
• Participate in internal, external, third-party, and regulatory audits, providing responses as needed.
• Support project team activities, investigations, and process improvement projects.
• Manage changes in the quality system, keeping information updated and available.
• Work closely with teams to ensure documents are complete, accurate, and up to date.
• Review the status of external calibration equipment/tools and coordinate their collection when required.
• Request monthly results from departments to produce the monthly metrics report.
• Track Calibration and Safety labels.
• Control communication documents with clients/suppliers, such as corrective actions, NCRs, and deviations.
• Perform documentary control of Work Instructions/Standard Operating Procedures.
• Verify proposed changes to procedures or records comply with the quality system standard.
• Participate as a member of the internal audit team.
• Supervise and ensure compliance with document control procedures and policies.
• Additional duties as assigned.

Requirements

• 1 to 5 years of work experience in Quality Departments.
• Preferred Bachelor’s or Associate degree in Engineering, Education, Technical, Business, Management, Science, Computer Science, Manufacturing, or Business/Administration.
• Experience working with a document control system that maintains and processes document revisions as approved by change control.
• Required knowledge of digital applications, file formats, and design limitations.
• Ability to organize, prioritize resources, and incorporate new information to implement effective solutions.
• Proficiency in Microsoft Windows, Mac, or other technical tools.
• Excellent communication skills, with the ability to convey messages clearly and explain policies/procedures effectively.
• Strong understanding of the impact of messages on the organization or customer.
• Experience in document control and internal audits.
• Proficient in Microsoft Office tools.
• Knowledge of ISO 9001:2015.
• Strong communication, interpersonal skills, and attention to detail.
• Ability to work autonomously, manage multiple tasks, and prioritize in a fast-paced environment.
• Must pass an E-Verify background check.

Preferred certifications: ISO, FDA, SQF, PO, MO, APICS, ASQ, 9001, GMO, LEAN.

Benefits

• Medical, dental, and life insurance.
• Long-term disability coverage.
• Paid time off (sick and vacation).
• 10 company holidays.
• 401(k) with company match.
• Referral Rewards program.

Benefits begin the first of the month following 30 days of employment.