Document Control Technician

Job Summary

Document Control Administrator assists the Quality Assurance and Regulatory Affairs team members in the maintenance, archiving and retrieval of all controlled documents and records required by applicable regulatory requirements. The Document Control Technician may assist in the development and preparation of such documents and records.

Key Accountabilities

• Assist in the development of an effective Document Control Center and relevant Standard Operating Procedures (SOPs) for the proofing, filing, copying, scanning, archiving, retrieval and maintenance of all controlled documents and records required by applicable regulations.
• Serve as custodian for all controlled documents and records filed in the Electronic Document Control Center or archived at the on-site warehouse or off-site contracted storage facility. Responsible for storage, retrieval and archiving of controlled documents and records.
• Responsible for processing DCRs (Document Change Requests) for all controlled documents.
• Perform tasks for filing master copies of new or revised controlled documents and for archiving obsolete documents as instructed in relevant departmental SOPs.
• Perform tasks for the creation, preparation and maintenance of the controlled documents master lists / databases to identify current revisions.
• Develops controlled document index listings for specific Controlled Book owners at their request.
• Creates queries for controlled document auditing and to address document inquiries, as requested.
• Performs other duties and responsibilities as assigned.

Reasonable accommodations may be made to enable individuals with disabilities to perform these essential functions.

Networking/Key relationships

Work with Quality Supervisor, Quality Manager, Regulatory Manager, Sr. Director QA/RA and cross functional teams on assigned projects and tasks. Support internal and external audits.

Minimum Knowledge & Experience required for the position:

• High School Diploma or GED/HSED equivalent required.
• Associate degree in Business Administration, Quality Systems, Life Sciences, Healthcare Administration, Information Management or a related field preferred.
• One year of demonstrated experience in document control, records management, quality administration, regulatory support, or a related administrative function.
• Experience maintaining controlled documents and records within a regulated environment.
• Experience using electronic document management systems and document databases.
• Experience managing document revision control, filing systems, retention schedules, and archival activities.

Management has the discretion of substituting relevant work experience for a degree and/or making exceptions to the years of experience requirement.

Skills & Capabilities:

• Understanding of document control principles, records management practices, and document lifecycle requirements.
• Ability to maintain confidentiality and integrity of controlled documents and company records.
• Strong verbal and written communication skills with the ability to proofread technical and quality documentation.
• Ability to review documents for formatting, completeness, accuracy, and compliance with established procedures.
• Strong database, indexing, and document retrieval skills.
• Ability to prioritize multiple requests and meet deadlines in a fast-paced environment.
• Strong analytical and problem-solving skills with the ability to generate reports, queries, and document metrics.
• Ability to work independently with minimal supervision while maintaining high levels of accuracy and compliance.
• Strong proficiency with Microsoft Office applications and electronic document management systems and databases.

Travel requirements:None

Werfen is an Equal Opportunity…