What are the responsibilities and job description for the Document Control Specialist/Quality Assurance/Technical Writing position at Accuro?
Business Title: Document Control Specialist
Location: Raleigh, NC
Job Type: 6 months contract
The Junior Business Analyst, R&D IT is responsible for working with the business units within R&D to gather requirements around their usage of the electronic Document Management System (eDMS), help the business units write process documentation such as SOPs, Work Instructions, How To Guides, etc. and then help the business units comply with the new process documentation. A successful candidate will have a mix of customer facing and document writing skills and will also perform some data entry and document control activities as part of the role.
Job Responsibilities:
- R&D Business Analysis
- Ability to lead and facilitate meetings, interact with R&D business users, and build strong relationships
- Ability to gather user requirements related to the use of electronic Document Management System (eDMS)
- Ability to translate requirements into a new functional process and develop a plan to move from the current process to the new process
- This activity constitutes ~20% of the job description
- Technical Writing
- Ability to write technical documents such as Standard Operating Procedures (SOPs), Work Instructions (WIs), and informal How To Guides
- Ability to write for a formal audience (SOPs, WIs) as well as for a specific business audience with a wide range of technical expertise
- This activity constitutes ~30% of the job description
- Document Control
- Ability to enforce business specific policies and procedures in a supportive manner
- Ability to use eDMS application as a power user, including developing and running reports, identifying procedural gaps, and assisting the business in resolving them
- Basic document management support related to document creation, editing, review, and approval including workflow management and support
- This activity constitutes ~50% of the job description
Skills & Experience Required:
- Bachelor’s Degree in Computer Science / Information Systems or related discipline
- 1-3 years of experience in a position of equal scope and responsibility
- Experience supporting a life sciences or medical device R&D organization
- Experience with electronic document management systems in an R&D or pharmaceutical setting
- Experience with MS Office applications
- Experience business process mapping, gap analysis, document control
- Preferred qualifications
- Experience with Computer Systems Validation and GxP relevant applications
- Subject Matter Expertise in Clinical, Laboratory, Quality, Regulatory, and/or Safety disciplines
- Six Sigma or process improvement related experience
