Document Control Specialist III (Temporary) - AID

Job Summary The Temporary 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 within areas of authority. Completes work in accordance with Inova Quality Management System. Responsibilities Document and Data Processing and Entry: Initiate and process change orders; review verbiage and content for errors, inconsistencies, and incompleteness; confirm documents and records comply with standardized formats and file naming conventions; confirm approvers are appropriate; communicate proactively with stakeholders; monitor aging change orders; facilitate issue resolution; ensure completion of implementation actions; 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 of 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 compliance 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; train new team members; assist in creation of training sessions; 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 of 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; pull requested audit documents and records; respond to auditor queries; represent Document Control in audits and inspections. Compliance: Follow applicable Werfen standard operating procedures, 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. Key Relationships Quality Teams Regulatory Teams Manufacturing Teams Operations Teams Marketing Teams Supply Chain Teams Legal & Human Resources Research and Development Teams Qualifications Education Bachelor’s degree in a relevant field (e.g., Life Sciences) or equivalent experience required. Knowledge Advanced knowledge of document lifecycle management and maintaining documents within quality system requirements. Advanced knowledge of ISO 13485 and related standards as they pertain to document, quality record, training records, labeling artwork control. Advanced knowledge of Good Documentation Practice (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). 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, 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, use hands to manipulate objects, reach with hands and arms, climb stairs, balance, stoop, kneel or crouch, and talk and hear. The noise level in the work environment will vary but is usually moderate. This position is very active and requires varying levels of mobility. May occasionally have to lift and/or move up to 25 pounds. The employee must have specific vision abilities including close vision, distance vision, color vision, peripheral vision, depth perception and the ability to adjust focus. Compensation and Benefits The annual base salary range for this role is currently $24.00 to $34.00 per hour. Individual employee compensation will ultimately depend on factors including education, relevant experience, skill set, knowledge, and particular business needs. This is a 3‑12‑month job contract. This role is eligible for medical, dental and vision insurance, 401(k) plan retirement benefits with an employer match, as well as paid vacation and sick leave. Sales roles are eligible for participation in a commission plan and management and select professional roles are eligible for a performance‑based bonus. EEO Statement 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 View email address on click.appcast.io for assistance. #J-18808-Ljbffr Werfen North America