Document Control Technician

Werfen • Waukesha, WI

3d

About The Position

Werfen is a family-owned diagnostics company founded in 1966 in Barcelona, Spain. It operates in specialized diagnostics, including Hemostasis, Acute Care Diagnostics, Transfusion, Autoimmunity, and Transplant, as well as customized assays and biomaterials through its OEM business. The company operates directly in 30 countries and in more than 100 territories through distributors, with a workforce of more than 7,000 employees.

The Document Control Technician assists the Quality Assurance and Regulatory Affairs team with maintaining, archiving, and retrieving controlled documents and records required by applicable regulations. The role may also assist with developing and preparing documents and records. It supports the Document Control Center, processes document change requests, maintains document masterlists and databases, and supports document inquiries and audits. The position works with quality, regulatory, and cross-functional colleagues on assigned projects and tasks.

Requirements

• High school diploma or GED/HSED equivalent required.
• 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 in a regulated environment.
• Experience using electronic document management systems and document databases.
• Experience managing document revision control, filing systems, retention schedules, and archival activities.
• 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, including proofreading 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, including generating reports, queries, and document metrics.
• Ability to work independently with minimal supervision while maintaining accuracy and compliance.
• Strong proficiency with Microsoft Office applications, electronic document management systems, and databases.

Nice To Haves

• Associate degree in Business Administration, Quality Systems, Life Sciences, Healthcare Administration, Information Management, or a related field preferred.

Responsibilities

• Assist in developing an effective Document Control Center and relevant SOPs for proofing, filing, copying, scanning, archiving, retrieving, and maintaining controlled documents and records.
• Serve as custodian for controlled documents and records held in the Electronic Document Control Center, on-site warehouse, or off-site contracted storage facility; manage their storage, retrieval, and archiving.
• Process Document Change Requests (DCRs) for controlled documents.
• File master copies of new or revised controlled documents and archive obsolete documents according to relevant departmental SOPs.
• Create, prepare, and maintain controlled-document masterlists and databases identifying current revisions.
• Develop controlled-document index listings for specific Controlled Book owners upon request.
• Create queries for controlled-document auditing and respond to document inquiries as requested.
• Support internal and external audits.
• Perform other assigned duties and responsibilities.

What This Job Offers

• Job Type: Full-time
• Career Level: Entry Level
• Education Level: High school or GED