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Analyst Ii, Document Control

2 weeks ago

Winnipeg, Canada Emergent Biosolutions Full time

Job Summary
The role is responsible for the administration and maintenance of the company’s controlled documents, records, and the document control system in accordance with company requirements. Monitoring completion of department tasks, training new employees and providing support during regulatory inspections.
Responsibilities (key responsibilities only. This should not be an all encompassing list)
Document Control Support
- Troubleshoot and provide support for internal 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.

Quality System Support
- Compile and report performance metrics for Document Control quality systems and provide recommendations to improve performance.
- Administer and maintain the company’s 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 company’s 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.
- Provide support during regulatory and internal inspections of Emergent quality systems.
- Assists with the management of third party audits.
- Lead quality events and investigations related to Document Control.
- Other duties as assigned.

The above statements are intended to describe the general nature of work performed by those in this job. It is not an exhaustive list of all duties, and other duties may be assigned.
Education, Experience & Skills
- Minimum of grade 12 education required. Bachelor degree preferred
- 2-4 years related experience.
- Experience in an FDA regulated industry.
- Experience with electronic document management systems.
- Strong computer skills with the Microsoft Office product line.
- Basic understanding of regulations governing document control and records management.
- The position requires excellent communication and organizational skills.
- The position must have strong interpersonal skills and have good attention to detail.