Specialist I, Quality Assurance

at  Emergent BioSolutions

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.
Job Summary
The Quality Assurance Deviations and CAPA Specialist provides support by managing deviations and corrective/preventative actions. Additionally, this position provides technical expertise in quality systems, manufacturing, quality control, supplier quality management and product development activities. This position will be responsible to ensure that all deviations and CAPA processes are completed and followed as per procedures.
Responsibilities
The Quality Assurance Specialist supports QA Management by providing technical expertise and advanced Quality Systems knowledge which ensures that the primary objective of manufacturing safe products at the Winnipeg facility that are in compliance with regulatory requirements. This position is primarily responsible for:
Non-Conformances
Quality Systems reports and improvement projects
Change actions review and approval Compliance with GMP requirements, good documentation practices and adherence to Emergent’s procedures

ADDITIONAL REQUIREMENTS:

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

Deviation and CAPA Management
Deviation administration through consultation, review, assessment and participation in deviation investigations
Ensuring complete investigation including product impact assessment and root cause analysis
Ensures CAPA address the root causes of deviations and prevent future recurrence
Performing deviation investigations
Preparation of deviation summaries and system reports
Review and approval of Deviations and CAPAs
Quality Systems reports and improvement projects
Inspection/Audit Management
Participate as a team member during regulatory inspections or customer audits
Act as QA representative on project teams or in meetings, and be able to represent QA at interdepartmental meetings
Aid in training of QA Specialists
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
A Bachelor of Science in a related discipline with a minimum 5 years of experience or equivalent level of skills and experience.
Advanced technical knowledge in a related scientific discipline, Quality Assurance, or Quality Systems is a requirement.
Broad and thorough technical and regulatory knowledge of current pharmaceutical analytical and manufacturing techniques / processes.
Solid working knowledge of FDA, Health Canada, and EMA GXP regulations, and the interpretation and application of these regulations to the work environment.
The ability to be detail and goal oriented, focused on team work and the customer, prioritize and adapt to business needs as required.
Excellent written and verbal communication, influencing, and negotiation skills are required to inspire trust and quickly build credibility with other departments at Emergent.
Ability to work collaboratively as a team or independently.