26 days old

Analyst I, Document Control

Winnipeg, MB R3B
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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)<>

Emergent BioSolutions is currently seeking an Analyst I, Document Control for our Winnipeg facility. The select candidate will have experience in an FDA regulated industry, experience with electronic document management systems and strong computer skills. Must have a basic understanding of regulations governing document control and record 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 missionto 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 roleis 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.

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 actionswhether it is our approach to product development, manufacturing, encouraging employee health and wellness or giving back to the communitywe strive every day to achieve this shared goal.

WE BELIEVE IN OUR VALUES

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

Industry

  • Biotechnology
Posted: 2023-02-24 Expires: 2023-03-27

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Analyst I, Document Control

Emergent BioSolutions Inc.
Winnipeg, MB R3B
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