Specialist , Quality Assurance-WIN

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Emergent is a leading public health company that delivers protective and life-saving solutions to
communities around the world. Here, you will join passionate professionals where our culture is informed by our values and commitment to protecting and saving lives.

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.

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:

• Deviation and CAPA Management
• 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

• 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
• Deviation 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
• 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.

• 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.
• Successful Completion of a Criminal Record Check.

There are physical/mental demands and work environment characteristics that must be met by an individual to successfully perform the essential functions of the job. This information is…