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Specialist I, Quality Assurance

1 month ago

Winnipeg, Canada Emergent Biosolutions Full time

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 ASSURANCE

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 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.

DUTIES & 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:
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

**Duties and responsibilities include**:
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

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.
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.

**ADDITIONAL REQUIREMENTS**:
Citizenship/Permanent Resident or Valid Work Permit.
Successful Completion of a Criminal Record Check.
Medical assessment will be req’d upon hire.