Document Control Specialist 3

Introduction

Werfen

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

The Document Control Specialist III guides, executes, and improves Document Control processes including document changes, quality records control, labeling creation, SAP master data entry, and training record maintenance activities. This role ensures compliance with organizational standards and regulatory requirements and improves the efficiency and quality of Document Control processes. The Document Control Specialist III demonstrates subject matter expertise in document control processes and regulatory requirements. The position is responsible for carrying out activities and facilitating processing associated with change orders, SAP training sessions, quality plan tasks, document and record processing, metrics, artwork for labeling, and other tasks to achieve department objectives. The Document Control Specialist III works closely with department management and other Quality teams to ensure activities and tasks are accurately and efficiently completed and also works independently; uses professional judgement to make decisions with in areas of authority. Completes work in accordance with Inova Quality Management System.

Responsibilities

Key Accountabilities

The main activities for this role include:

• Document and Data Processing and Entry - Initiate and process change orders: review change orders verbiage and content for errors, inconsistencies, and incompleteness; confirm documents and records comply with standardized formats and file naming conventions; and affected items; confirm approvers are appropriate to the change; communicate proactively with stakeholders to ensure efficiency of change order processing; work with change owners and reviewers on required corrections and clarifications; monitor aging change orders and facilitate issues resolution in a timely manner; ensure completion of implementation actions prior to effective status of the change; and coordinate periodic review. Maintain signature and delegation records. Create and maintain SAP master data. Ensure physical controlled copies are maintained at point of use.
• Document and Record Lifecycle Management- Optimize processes while performing creation, acceptance, review, storage, distribution, and archiving controlled documents and records from initiation through obsolescence and disposal.
• Department Procedures - Create and revise document and record lifecycle management, training, and product labeling SOPs, work instructions, checklists, forms, and templates. Maintain accuracy and compliancy of procedures.
• Process Improvement - Lead and implement Document Control department process improvements for accuracy, efficiency, effectiveness, and cycle times. Make process corrections based on process data trends. Represent Document Control in cross-functional projects.
• Training & Support - SME for training in Document Control department activities and requirements. Develop, deliver and maintain training materials for document control practices to the organization. Train new team members to procedures. Assist in creation of training sessions, and follow-up on completion of training by users.
• Metrics & Reporting - Maintain tracking data and reporting documents, labeling, and training metrics, reports, and dashboards. Analyze and respond to trends.
• Product Labeling - Optimize processes while performing creation, review, maintenance, and archiving product labeling from initiation through obsolescence. Print restricted product labeling.
• Quality Records Management - Optimize processes while performing scanning, filing, archival and disposal of paper and electronic quality records through required retain durations as well as processing quality records for off-site storage.
• Audit Support - Support internal and external audits and regulatory inspections. At minimum, pull requested audit documents and records, respond to auditor queries, represent Document Control in audits and inspections.
• Compliance - Follow applicable Werfen standard operating procedures (SOPs), national and international and other Quality System regulations, ISO standards, as well as applicable Environmental Health & Safety, Human Resources and all other regulatory and administrative policies..
• Perform other duties and responsibilities as assigned.
• Embodies Werfen values and aligns daily actions with department goals and company culture.

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

Networking/Key relationships

• Quality Teams
• Regulatory Teams
• Manufacturing Teams
• Operations Teams
• Marketing Teams
• Supply Chain Teams
• Legal & Human Resources
• Research and Development Teams

Qualifications

Minimum Knowledge & Experience required for the position:

Education: Bachelor’s degree in a relevant field (e.g., Life Sciences) or equivalent experience required.

• Advanced knowledge of document lifecycle management and maintaining documents within quality system requirements.
• Advanced knowledge of Quality Management System regulations ISO 13485, and related standards as pertain to document, quality record, training records, labeling artwork control.
• Advanced knowledge of Good Documentation (GDP) and Good Records Practices (GRP).

Experience: Minimum of 7 years of document control related experience preferably in vitro diagnostics or medical devices.

• Advanced experience in drafting, updating, and implementing SOPs, work instructions, forms, templates, and other QMS controlled documents.
• Advanced experience in document control configuration and document lifecycle management within a regulated quality management system.
• Advanced experience with SAP for document control and material master management.
• Experience leading departmental projects as well as providing representation in interdepartmental projects.
• Experience with quality-related training systems.
• Experience with computerized information systems (e.g., ERP, eDMS, LMS) required.
• Proficient in Microsoft Office Suite.

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

Skills & Capabilities:

• Attention to Detail & Accuracy: Thorough attention to detail and commitment to accuracy; ensures completeness and precision in documentation.
• Organization & Time Management: Proficient organizational skills with the ability to manage multiple priorities and meet deadlines in a fast-paced environment.
• Communication: Proficient written and verbal communication skills in English; able to effectively communicate and train on document control requirements and processes.
• Collaboration & Interpersonal Skills: Advanced interpersonal skills for cross-functional collaboration; able to influence and negotiate to achieve optimal outcomes.
• Customer Service Orientation: Responds promptly to requests and drives stakeholder satisfaction.
• Process Improvement: Ability to analyze current processes, identify gaps, and implement effective solutions.
• Adaptability: Ability to support changing business needs and work effectively in dynamic environments.
• Problem-Solving: Proficient in identifying and resolving complex issues and problems; seeks help and guidance for cross-functional issues and problems.
• Proficient capability in Microsoft Office Suite.

Travel requirements:None

Work Environment

The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job.  While performing the duties of this job, the employee is regularly required to communicate. Must be able to detect, identify and inspect scientific data. The employee will be required to stand and/or walk up to 8 hours per day and/or sit for up to 8 hours per day.  Must be able to use hands to feel objects, including keyboard, telephone and pipettes or other lab equipment.  May need to reach with hands and arms, climb stairs, balance, stoop, kneel or crouch.  Will be required to talk and hear and have specific vision abilities, including close vision, distance vision, color vision, peripheral vision, depth perception and ability to adjust focus.  May occasionally have to lift and/or move up to 25 pounds.  The noise level in the work environment will vary but is usually moderate.  This position is very active and requires varying levels of mobility. 

The annual base salary range for this role is currently $24.00 range to $34.00 range. Individual employee compensation will ultimately depend on factors including education, relevant experience, skillset, knowledge, and particular business needs.

This role is eligible for medical, dental, and vision insurance, 401k plan retirement benefits with an employer match, as well as paid vacation and sick leave. Our sales roles are eligible for participation in a commission plan and our management, and select professional roles, are eligible for a performance-based bonus.

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 [email protected] 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

Closing

If you are interested in constantly learning and being challenged on a daily basis we encourage you to submi

Werfen is an Equal Opportunity employer and is committed to a diverse workplace. Werfen s trictly 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 [email protected] for assistance.t your resume or CV. 

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