Analyst II, Document Control

Emergent Biosolutions • Winnipeg, MB

8d

About The Position

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.

Requirements

• Minimum of grade 12 education required.
• 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.
• Excellent communication and organizational skills.
• Strong interpersonal skills and good attention to detail.

Nice To Haves

• Bachelor degree preferred.

Responsibilities

• 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, reconciliation 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.
• 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 and global 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.
• Other duties as assigned.

Benefits

• highly diverse career opportunities
• a supportive culture
• competitive salaries
• flexible work arrangements
• an extensive benefits package

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level
• Education Level: High school or GED