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Specialist I, Quality Systems

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.

 

SPECIALIST I, QUALITY SYSTEMS

1 Year Term Position

 

Emergent BioSolutions is currently seeking a Specialist I, for our Quality Systems Department. The successful candidate will have a bachelor’s degree, preferably in an applied science, a minimum of 5 years of related experience and a minimum of 5 years’ experience working in a Health Canada/FDA related industry. Must have a high understanding of CAPA and change control systems and expert level understanding of regulations governing supported process and systems. The ideal candidate will have strong leadership skills, the ability to work individually and in a team environment, and the ability to effectively communicate and make sound decisions regarding quality and compliance. 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

 

Quality System Support

  • Serve as process owner for the change management system:
    • Act as process subject matter expert with detailed knowledge of process history, compliance and operations
    • Monitor performance metrics, including identification of trends that require preventive action and cross-functional collaboration to determine the root cause of process performance issues, and taking the necessary action to improve performance
    • Present objective data regarding process performance to Functional Area and Senior Management
    • Maintain up-to-date knowledge of industry and regulatory trends to ensure system remains compliant with stated expectations and best practices
  • Author and execute tasks for change controls, and document revisions, schedule, and conduct site training for supported quality systems as needed, assess effectiveness of training following completion
  • Serve as the Quality Assurance role for change control
  • Represent the Quality Systems department in a review and decision-making capacity on site projects
  • Coordinate work across systems, functions, and sites to harmonize workflow, clearly identify responsibilities, and optimize cross-functional team member participation
  • Network with counterparts at other sites to leverage and implement best practices
  • Perform gap analyses to identify training needs and work cross-functionally to best practices are in use to support the quality systems
  • Coordinate/lead cross-functional teams in process mapping and other exercises designed to facilitate process and system understanding
  • Assist in the development of procedures and other documents to accurately reflect work practices, including application of documentation format, structure, and hierarchy standards
  • Actively apply quality tools and training to ensure the best possible outcome of quality improvement efforts

 

Continuous Improvement

  • Identify opportunities for improvement within scope of work
  • Maintain documentation of quality improvement efforts that is suitable for presentation to site leadership and during audits & regulatory inspections

 

Regulatory Inspections

  • Lead logistical support and technical knowledge during internal audits and regulatory inspections of Emergent quality systems, including interacting directly with audit and regulatory personnel to discuss areas of expertise
  • Lead on response teams to address observations and recommendations made during internal audits and inspections

 

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: 

 

Education

  • Bachelor's degree, preferably in an applied science
  • American Society for Quality (ASQ) Quality Process Analyst, Lean, or Manager of Quality/Organizational Excellence certification (preferred)

 

Experience

  • Minimum of 5 years related experience
  • Minimum of 5 years in a Health Canada/FDA regulated industry

 

Knowledge

  • High understanding of CAPA, and change control systems
  • Expert understanding of regulations governing supported processes and systems

 

Skills

  • Strong computer skills with the Microsoft Office product line
  • Strong leadership skills; high level of personal/departmental accountability and responsibility

 

Abilities

  • Ability to work individually and in a team environment with minimal supervision
  • Ability to effectively communicate (orally and written) with all levels of personnel at multiple company locations
  • Ability to make sound decisions regarding quality and compliance related issues
  • Ability to lead small groups of employees to accomplish common goals

 

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.