Job Description
Job Summary: restor3d is a fast-growing company bringing innovative technology to our patients and surgeons, expanding the reach of personalized medicine. The Document Control Specialist will be responsible for supporting the Quality team by managing the daily document control system. The Document Control Coordinator assists with the maintenance and processing of documentation, provides quality system support to all departments within the company, maintains Device History Records as part of the quality system, updates materials in the ERP system as required by document change requests, and maintains department databases. This role is an on-site position at our Wilmington, MA location.
Duties and responsibilities: - Administering changes to documents in accordance with company requirements
- Maintaining production records to ensure compliance with FDA and internal record retention requirements
- Maintaining Training system
- Updates materials in the ERP system as required by document change requests
- Reviewing records to ensure Good Documentation Practices (GDP) are being followed
- Tracking of all routing and approval stages
- Ensuring new documents and records are consistent with company procedures
- Reviewing documentation for accuracy, completeness, and consistency in content, format, files, and approvals
- Develop and maintain strong internal working relationships across restor3d
- Understand the objectives, responsibilities, and mission of the Quality department and work towards those goals
- Prioritize and plan work activities; adapt for changing conditions
- Data Collection and entry
- Other responsibilities as assigned
Qualifications and experience: - Excellent written and verbal communication skills
- Strong attention to detail
- Able to work accurately in a fast-paced, ever-changing environment
- Demonstrated ability to monitor own work to ensure quality, accuracy, and thoroughness
- Strong organizational, analytical, and time-management skills
- Able to self-motivate and work both independently and as part of a team
- Ability to plan, organize, and multi-task to meet deadlines
- Perform responsibilities under minimal supervision
Education: - Associate's Degree in a technical field or equivalent experience.
- 1-3 years of experience in an Administrative or Clerical role.
- Proficiency in MS Office.
Preferred Skills: - 18 months or more of Quality Assurance and experience in a FDA regulated environment is preferred with QSR (21 CFR Part 820) experience if possible.
- Understanding of cGMP, GDP, ISO 13485.
- Experience with technical documentation, medical device or manufacturing environment preferred
- eQMS (TMS) experience a plus
- Experience in FDA Regulated environment preferred
- ERP/MRP (Oracle/SAP) experience a plus
- Sharepoint experience a plus
Physical Requirements: - Prolonged periods sitting at a desk and working on a computer.
- Ability to lift, push, and pull up to 50 lbs.
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