Sr. Quality Document Specialist

Duration: 1 Year

Responsibilities:

• Manage and maintain document control activities per SOP and regulatory requirements following Good Documentation Practices.
• Develop and/or update workflows, policies, and procedures to govern archival and record retention processes .
• Identify and make recommendations for improvements to document management system.
• Review companywide Quality Management Systems (QMS) SOPs, work instructions and accompanying forms.
• Ensure all approved documents are maintained throughout the document lifecycle.
• Manage all controlled records both hard copy and electronic .
• Maintain record retention library and secure access.
• Help support maintenance of training curricula and related documents.
• Identify and facilitate the resolution of any document control discrepancies or issues (escalate as necessary)
• Master Document Log maintenance including document status and revision level.
• Obsolete documentation maintenance, preventing usage of outdated material.
• Assists in the documentation of key processes and departmental procedures.
• Receives, classifies, files, audits, tracks, and maintains centralized documentation archiving system of controlled Quality System documents according to established procedures.
• Responsible for file maintenance and record keeping; locates and retrieves file material upon request from record archiving location.
• Assists in the preparation of legacy documents for migration into an electronic document control system.
• Assist as required in regulatory inspection activities.
• Effectively follows the company's standard operating procedures.
• Understands the basic principles and concepts of the documentation lifecycle and associated electronic systems.
• Partners with cross-functional associates to meet compliance requirements.
• Guides change initiators in the development of accurate changes.
• Ensures changes and documentations follow the company's policies and procedures.
• Maintains filing of technical files, listings, certificates, licenses, etc.
• Compiles data for the creation of metrics and reports for various departmental activities.
• They establish individual training plans and ensures appropriate training is administered throughout the company.

Knowledge/Skills/Abilities

• Initiative - self-starter who is pro-active by taking action to improve a situation without waiting for explicit instructions, recognizes and responds to opportunities in order to reach a goal, seeks new and improved techniques, solutions, and approaches to completing assignments.
• Adaptability –remains fully functional by adapting to changing circumstances (environment, procedures, people)
• Planning and organizing – proficient at determining goals and priorities and to assess the actions, time, and resources heeded to achieve those goals.
• Multi-tasking - effectively handles multiple tasks in a changing environment.
• Communication skills – expresses oneself clearly and effectively when speaking and/or writing to individuals or groups, listens attentively, ensures that information is understood by all parties, shares information in a timely manner using the most appropriate method, presents well-organized information in a group setting.
• Fostering teamwork and collaboration - collaborative style – advocating a positive team concept to resolve problems and achieve optimal results.
• Attention to detail – proficient at processing detailed information effectively and consistently.
• Follow up – takes appropriate action to ensure a task, activity, or function has been completed.
• Technical skills - must be proficient-to advanced user of Microsoft Office 365/Suite products such as Word, Excel, PowerPoint, Outlook, and SharePoint

Education And Experience

• Bachelor’s degree and 3 – 5 years’ experience in a similar role
• Technical Writing /Document Control experience preferred.
• Training experience
• Experience in a regulated environment (medical device or pharmaceutical) is preferred.
• Tenacious attention to detail and consistency is required.
• Excellent communication and interpersonal skills working within all levels of the organization required.
• Working knowledge of Microsoft office tools (Word, Excel, Outlook, and PowerPoint)