Documentation Specialist (19-00450) – NC – Raleigh

Job Summary:
Accountable for Document Control function at the Raleigh site. Act as subject matter expert for Client’s electronic document management system (eDMS). This includes controlling documents throughout the lifecycle, training and assisting system users, reviewing, approving, and executing system change control and validation documentation, and identifying and resolving compliance issues. Facilitate off-site storage and retrieval of departmental records. Assist with creating and revising departmental record retention schedules. Perform internal audits of documents and records and manage the periodic review process.

Exercises judgment in cooperation with Quality Systems management to oversee and manage a controlled document process for Raleigh site and several departments. Control over 700 documents for at least 18 departments. Provide support and system training for 130 + users at five sites as needed.

Essential Functions:
1. Business owner for eDMS (Controlled Documents)
2. Review and approve eDMS change control and validation documentation in cooperation with QS management
3. Control documents and provide end user support and training for eDMS
4. Provide records management support to Raleigh Quality Operations
5. Ad hoc projects and tasks
6. Perform internal document and record audits.
7. Manage periodic review process.

• High school diploma or GED
• 5+ years of document control/administration experience in the pharmaceutical/biotech industry, preferably in QA or QC.
• Strong oral and written communication skills
• Ability to interpret and apply GMPs, relevant laws, guidance and directives
• Attention to detail
• Ability to coordinate activities with multiple functional groups with a sense of urgency and exercise independent judgment in developing methods, techniques and evaluation criteria for obtaining solutions.
• Strong computer skills (preferably MS Office, Adobe Acrobat Pro, WebEx, Java, and Documentum)
• Ability to lift 30 pounds
Source: Job Diva – Job Listing

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