Job Description

Introduction

Werfen is a growing, family-owned, innovative company founded in 1966 in Barcelona, Spain. We are a worldwide leader in specialized diagnostics in the areas of Hemostasis, Acute Care Diagnostics, Transfusion, Autoimmunity, and Transplant. Through our Original Equipment Manufacturing (OEM) business line, we research, develop, and manufacture customized assays and biomaterials. We operate directly in 30 countries, and in more than 100 territories through distributors. Our Headquarters and Technology Centers are located in the US and Europe, and our workforce is more than 7,000 strong.

Our success comes from a specific focus in these rapidly evolving diagnostic areas, our commitment to customers, and our dedication to innovation and quality. We’re passionate about providing healthcare professionals the most valuable and complete solutions to improve hospital efficiency and enhance patient care.

Overview

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.

Responsibilities

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 masterlists / 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.

Qualifications

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

Closing

If you are interested in constantly learning and being challenged on a daily basis we encourage you to submit your resume or CV.

Werfen is an Equal Opportunity employer and is committed to a diverse workplace. Werfen strictly prohibits unlawful discrimination, harassment or retaliation based upon an individual’s race, color, religion, gender, sexual orientation, gender identity/expression, national origin/ancestry, age, mental/physical disability, medical condition, marital status, veteran status, or any other protected characteristic as defined by applicable state or federal law. If you have a disability and need an accommodation in relation to the online application process, please contact NAtalentacquisition@werfen.com for assistance.

We operate directly in over 30 countries, and in more than 100 territories through distributors. Annual revenue is approximately $2 billion and more than 7,000 employees around the world comprise our Werfen team.

www.werfen.com