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Analyst II, Document Control

Location: 

Winnipeg, MB, CA, R3T 5Y3

 

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 II, DOCUMENT CONTROL (Canada)

 

Emergent BioSolutions is currently seeking an Analyst II in the Document Control Department in Winnipeg. The select candidate will have 2-4 years of related experience, strong computer skills with the Microsoft Office product line and a basic understanding of regulations governing document control and records management. In addition, this individual will possess a strong work ethic and a commitment to excellence and innovation.

 

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 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.

 

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, 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.
  • 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 Requirements

  • 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.

 

 

ADDITIONAL REQUIREMENTS:

  • Citizenship/Permanent Resident or Valid Work Permit.
  • Successful Completion of a Criminal Record Check.

 

Interested? Please visit www.emergentbiosolutions.com under the career section to apply today!

 

 

As part of our team, you'll join talented and inspiring colleagues whose sense of purpose complements your own. We offer highly diverse career opportunities, a supportive culture, competitive salaries, flexible work arrangements and an extensive benefits package. Information submitted will be used by Emergent BioSolutions for activities related to your prospective employment. Emergent BioSolutions respects your privacy and any use of the information submitted will be subject to the terms of our Privacy Policy.

ABOUT EMERGENT

Protecting and Enhancing 1 billion lives by 2030 focuses our energy to improve the quality of life for individuals around the world, giving them the opportunity to experience the fullness of life.

Our drive towards this vision informs all of our actions—whether it is our approach to product development, manufacturing, encouraging employee health and wellness or giving back to the community—we strive every day to achieve this shared goal.

WE BELIEVE IN OUR VALUES

  • Stand shoulder to shoulder no matter what
    • We combine our best thinking and communicate openly to support each other.
  • Break through thinking
    • We take smart risks, pursue innovation and challenge ourselves to constantly improve.
  • Own it always
    • Every person at Emergent is engaged and accountable for delivering on our commitments.
  • Compete where it counts
    • We set the right goals and respect each other as we conquer them together.