Specialist I, Quality Assurance-WIN

Emergent BioSolutions, Inc.; Winnipeg; On-site; CAD 80,000 - 110,000; Full time

Job summary

Emergent BioSolutions in Winnipeg seeks a Quality Assurance Deviations and CAPA Specialist to manage deviations and CAPA processes, ensuring QA systems support safe, compliant manufacturing. The role provides technical leadership in deviations, CAPA, and quality systems across GMP environments.

The successful candidate will review investigations, lead root cause analyses, and participate in regulatory inspections or customer audits while training QA staff and collaborating with cross-functional

Qualifications

• BS in a related discipline with 5+ years of experience.
• Advanced technical knowledge in QA or Quality Systems.
• Broad regulatory knowledge of FDA, Health Canada, EMA GXP regulations.
• Detail-oriented, team-focused, customer-oriented.
• Excellent written and verbal communication; ability to influence.

Responsibilities

• Manage deviations and CAPA investigations with root cause analysis.
• Prepare deviation summaries and system reports.
• Review and approve Deviations and CAPAs.
• Support QA during regulatory inspections or customer audits.
• Train QA specialists and participate in cross-functional teams.

Skills

Quality Systems

GXP regulations

Analytical skills

Regulatory compliance

Communication skills

Education

Bachelor of Science

Job description

Preparedness today, safer tomorrow. Emergent is a leading public health company that delivers protective and life-saving solutions to

Preparedness today, safer tomorrow. 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.

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:

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

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.

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 available upon request from the candidate.

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.

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