Document Control Specialist III

Werfen • San Diego, CA

1d • $24 - $34

About The Position

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.

Requirements

• 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.
• 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.

Responsibilities

• 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.

Benefits

• 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.

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level
• Number of Employees: 5,001-10,000 employees