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Specialist I, QA Compliance

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, QA COMPLIANCE (CANADA)

 

Emergent BioSolutions is currently seeking a Specialist I, QA Compliance for our Winnipeg location. The successful candidate will possess a bachelor’s degree in science, a diploma in Medial Technology, a registered nurse or equivalent level of skills and experience. A minimum of 5 years’ experience in the pharmaceutical industry required. Industry certification or diplomas in Quality Management, Auditing, and/or Quality Systems is considered an asset. Must have practical experience with quality systems development, documentation and implementation. Must have excellent written, oral and interpersonal skills and experience managing multiple projects in a fast paced environment. 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 primary function of the Specialist I, Quality Compliance is to provide quality management compliance oversight of GXP functions. This is accomplished through:

 

  • Development, implementation, maintenance, and continuous improvement of relevant Quality Systems.
  • Representation of Quality Compliance as a team member at project meetings.
  • Direct Quality Assurance oversight of the work performed by Operational partners (e.g. GMP, GLP, Plasma Quality Assurance) and ensuring quality of work through reviews of protocols, reports, approval of procedures, non-conformance investigations, change controls, corrective action plans, and the conduct of well-planned internal and external audits to ensure compliance with established procedures and regulatory requirements.

 

This role may provide compliance oversight to one or more than one of the GXP disciplines under the purview of the GXP Compliance group.

 

DUTIES & RESPONSIBILITIES

 

  • Assess and monitor GXP compliance status of GLP, GMP, Plasma and Supply Quality Operations, including that of related vendors. Accomplished through the execution of internal and external compliance audits.
  • Conduct internal systems and study audits.
  • Conduct external audits: supplier qualification of vendors with majority of focus on plasma suppliers. Track audit findings, corrective action and their implementation to completion
  • Maintain Audit Plans
  • Draft, negotiate and finalize Quality Agreements for management approval
  • Support the site Supply Quality Management program
  • Support preparation for, hosting and management of customer and regulatory inspections
  • Review and approve Customer Inquiries (includes review of product inquiries, oversight and investigation of product complaints, and review of medical inquiries).
  • Identify, and advise Management of, key risks
  • Work with stakeholders to define mitigation strategies and implement appropriate risk controls and corrective action plans.
  • Be a compliance resource in interpretation and application of regulatory requirements for internal customers in various GXP disciplines
  • Assess and review Change Controls, Document Change Requests & Deviations, Lookbacks, and CAPAs.
  • Maintain knowledge of quality and compliance regulations and standards to facilitate functioning as an internal subject matter expert and provide compliance assessments when requested.
  • Creation, revision and review of quality systems, processes, and standards.
  • Lead project teams as assigned. Provide compliance support and guidance as QA representative on assigned project teams
  • Provide quality assurance support to GLP regulated operations through the assessment of GLP related changes to procedures, protocols, and study reports. This includes ensuring that Test Site Management, Study Director and/or Investigators are informed of compliance issues related to GLP studies and associated facilities.

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: 

 

  • Bachelor’s degree in science from an accredited University, Diploma in Medial Technology, registered Nurse or equivalent level of skills and experience.
  • Minimum of 5 years’ experience in the Pharmaceutical industry (or equivalent Life Sciences industry) in supporting areas such as Clinical, Non-Clinical (GLP), Plasma, quality investigations, supply quality management, and/or internal/external auditing
  • Previous experience in a minimum of one of the following GXP disciplines (GCP, GVP, GMP, Plasma and GLP) including a strong working knowledge of domestic and international compliance regulations including those of Health Canada, US FDA, and the EMA.
  • Industry certifications or diplomas in Quality Management, Auditing, and/or Quality Systems considered an asset.
  • Will have a fundamental understanding of quality philosophies, principles, systems, methods, tools, and standards.
  • Will have practical experience with quality systems development, documentation, and implementation necessary to meet domestic and international standards.
  • Will be able to develop and implement quality programs including tracking, analyzing, reporting and problem solving.
  • Excellent written, oral and interpersonal skills.
  • Experience in managing multiple projects in a fast paced environment.
  • Willingness and ability to function with minimal supervision and as part of a cross-functional team of professionals. 

 

ADDITIONAL REQUIREMENTS:

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

 

Interested? Please visit www.emergentbiosolutionscom.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.