Analyst I, Document Control

6 days ago

Winnipeg, Canada Emergent Biosolutions Full time

Those who join Emergent BioSolutions feel a sense of ownership about their future. You will excel in an environment characterized by respect, innovation and growth opportunities. Here, you will join passionate professionals who advance their scientific, technical and professional skills to develop products designed-to protect life.

ANALYST I, DOCUMENT CONTROL (CANADA)

THE COMPANY

Emergent BioSolutions is dedicated to one simple mission—to protect and enhance life.
As a global specialty pharmaceutical company, Emergent offers specialized products to healthcare providers and governments to address medical needs and emerging health threats.

We value the diversity that each employee brings, and while we look for people who share our Core Values, we thrive on difference as well. With hundreds of talented employees working around the globe, Emergent is a growing organization with a wide variety of scientific, technical and professional career opportunities worldwide.

THE OPPORTUNITY

The role is responsible for the execution of tasks within the Document Control department to support GxP activities, including issuing, reconciling, scanning, and archiving records. Processing and releasing controlled documents. Monitoring completion of department tasks and training new employees. Providing support during regulatory inspections.
DUTIES & RESPONSIBILITIES

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, verification, 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.

Records Management
Oversight and support of classification, filing, storage and retrieval of Emergent GxP records.

Quality System Support
Provides support to authors and task owners for document creation, revision and archival.
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.
Assist with the development and on-going maintenance of an electronic document management system.
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**:
0-2 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.

**ADDITIONAL REQUIREMENTS**:
Citizenship/Permanent Resident or Valid Work Permit.
Successful Completion of a Criminal Record Check.

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