Document Control Specialist
- 2501 Aerial Center Pkwy, Morrisville, NC 27560, USA
Spencer Health Solutions (www.spencerhealthsolutions.com) is transforming healthcare by moving care delivery to the home through the company’s spencer® medication adherence and engagement platform. The spencer FDA Class I technology enables virtual care by connecting patients, clinicians, pharmacists, and family members digitally.
The Morrisville company offers the right candidate an opportunity to be part of a high-performing team in the development of cutting-edge medical technology at the exciting point of market entry through leading health technology distributors in the US, Canada, and Europe.
The Document Control Specialist is responsible for managing company documents while also ensuring their accuracy, quality and integrity. The Specialist will help the company adhere to record retention policies, safeguard information and retrieve data more effectively.
- Maintain PLM system documentation (Control of records and documentation, Item numbers, Change Requests etc.)
- Maintain configuration of Arena (PLM)
- Coordinate change review and approval process
- Manage DMR and associated documentation
- Maintains tracking system for external standards
- Assist in supporting audits, coordinating activities
- Maintains quality records per SOPs
- Investigates and responds to corrective actions related to document control, training, external standards
- A minimum of five years of work experience in document management or related experience
- Experience with Arena or other electronic document control system
- Must possess a working knowledge of document control processes
- General understanding of ISO 13485
- Distinctive problem solving, organizational, and analytical skills
- Ability to work independently and be self-directed
- Proficiency in Microsoft Office applications (Word, Excel and Access)
- Excellent written and oral communication skills and a strong attention to detail
- Must possess the ability to maintain confidentiality and appropriately handle sensitive documents
Spencer Health Solutions is an Equal Opportunity Employer and do not discriminate against any employee or applicant for employment because of race, color, sex, age, national origin, religion, sexual orientation, gender identity, status as a veteran, and the basis of disability or any other federal, state or local protected class. All your information will be kept confidential according to EEO guidelines.