I. JOB SUMMARY

The role is responsible for the administration and maintenance of controlled documents, records, and the document control system in accordance with GMP and company requirements.  Timely completion of department tasks, and training new employees.

Provide support during regulatory inspections.

II. ESSENTIAL FUNCTIONS

Reasonable accommodations will be made to enable individuals with disabilities to perform the essential functions.

Document Control Support

• Provide support for internal and external customers with technical questions related to Document Control quality systems.
• Support completion of department operational tasks related to record and document issuance, processing, and archival.
• Conduct routine audits of department operational processes and provide recommendations for improvement.
• Conduct new department employee training on operational procedures and provide input on new and revised training content.
• Execute user testing for supported computer system program changes.

Quality System Support

• Author and execute tasks for document revisions, non-conformances, CAPAs, and change controls related to Document Control quality system performance.

• Compile and report performance metrics for Document Control quality systems and provide recommendations to improve performance.
• Administer and maintain the companys Electronic Document Management System (management and maintenance of system information).
• Creation of standardized procedures and work instructions for Document Control.
• Creation and maintenance of training material for companys Electronic Document Management System.
• Represent the Document Control department on site projects.

• Oversee assignment and tracking of internal customer requests, including responsibility for service requests from other departments in the organization.
• Identify opportunities for improvement within scope of work.

Regulatory Inspection

• Provide support and technical knowledge during regulatory, internal and client inspections of Emergent quality systems.
• Participate on response teams to address observations and recommendations made during inspections.

III. MINIMUM EDUCATION, EXPERIENCE, SKILLS

Education: BS degree or equivalent level of skill and experience.

Experience:    

• 3-6 years related experience.
• Experience with electronic document management, non-conformance, CAPA, and change control systems.
• Minimum of 3 year in an FDA regulated industry.
• Strong computer skills with the Microsoft Office product line.
• Moderate understanding of regulations governing document control and record management.
• Ability to effectively communicate (orally and written) with all levels of personnel at multiple company locations.
• Ability to work individually and in a team environment with minimal supervision.

Skills: Knowledge of MS Word, Excel and PowerPoint.

Other Requirements:

Requires vaccination against different viruses including Vaccinia virus.