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Werfen North America · 2 days ago

Document Control Specialist III

San Diego, CA

Full-time

Onsite

Senior Level

$24/hr - $34/hr

7+ years exp

Werfen North America is a global leader in the development and production of diagnostic solutions. The Document Control Specialist III is responsible for guiding and improving Document Control processes to ensure compliance with organizational standards and regulatory requirements while enhancing efficiency and quality in document management.

Health CareManufacturing

Responsibilities

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

Optimize processes while performing creation, acceptance, review, storage, distribution, and archiving controlled documents and records from initiation through obsolescence and disposal

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

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

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

Maintain tracking data and reporting documents, labeling, and training metrics, reports, and dashboards. Analyze and respond to trends

Optimize processes while performing creation, review, maintenance, and archiving product labeling from initiation through obsolescence. Print restricted product labeling

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

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

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

Embody Werfen values and align daily actions with department goals and company culture

Qualification

Document Lifecycle ManagementQuality Management System RegulationsSAP Master Data ManagementSOP DevelopmentQuality Records ManagementDocumentation PracticesCustomer Service OrientationProcess ImprovementMicrosoft Office SuiteAttention to DetailOrganization SkillsCommunication SkillsCollaboration SkillsAdaptabilityProblem-Solving

Required

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)

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

Thorough attention to detail and commitment to accuracy; ensures completeness and precision in documentation

Proficient organizational skills with the ability to manage multiple priorities and meet deadlines in a fast-paced environment

Proficient written and verbal communication skills in English; able to effectively communicate and train on document control requirements and processes

Advanced interpersonal skills for cross-functional collaboration; able to influence and negotiate to achieve optimal outcomes

Responds promptly to requests and drives stakeholder satisfaction

Ability to analyze current processes, identify gaps, and implement effective solutions

Ability to support changing business needs and work effectively in dynamic environments

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