Specialist I, Quality Assurance-WIN

Emergent BioSolutions; Winnipeg; On-site; CAD 85,000 - 115,000; Full time

Benefits offered by this job

Competitive salaries

Flexible work arrangements

Extensive benefits package

Job summary

Emergent BioSolutions in Winnipeg is seeking a Quality Assurance Deviations and CAPA Specialist to manage deviations and CAPA processes, ensuring investigations include root cause analysis and effective corrective actions in support of GMP-compliant manufacturing.

The role collaborates with QA, manufacturing and quality control to maintain product quality, support regulatory inspections, and drive continuous improvement across the quality systems at the Winnipeg facility.

Qualifications

• Bachelor of Science in a related discipline with 5+ years of experience or equivalent.
• Advanced knowledge of Quality Assurance, Quality Systems and CAPA.
• Strong understanding of FDA/Health Canada/EMA GXP regulations.

Responsibilities

• Deviation and CAPA management and investigations
• Non-conformances handling and root cause analysis
• Quality Systems reports and improvement projects
• Inspection and audit management
• Support regulatory inspections and customer audits
• Train QA specialists

Skills

CAPA Management

Deviation Handling

Quality Systems

GXP Knowledge

Root Cause Analysis

Documentation Skills

Regulatory Expertise

Education

Bachelor of Science

Job description

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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.

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. 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

Emergent prepares those entrusted with protecting their communities against current and future health threats.

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

• Lead with Integrity
  • We gain trust and confidence through ethics, quality, and compliance excellence
• Stand shoulder to shoulder
  • We combine our best thinking and communicate openly to support each other.
• Own it always
  • We are engaged and accountable for delivering on our commitments.
• Breakthrough thinking
  • We take smart risks, pursue innovation and challenge ourselves to constantly improve.
• Compete where it counts
  • We set the right goals and respect each other as we conquer them together.