At a Glance
- Tasks: Manage quality assurance deviations and corrective actions to ensure safe product manufacturing.
- Company: Emergent, a leading public health company dedicated to saving lives.
- Benefits: Competitive salary, flexible work arrangements, and extensive benefits package.
- Other info: Collaborative culture with diverse career opportunities and supportive colleagues.
- Why this job: Join a passionate team making a real impact in public health.
- Qualifications: Bachelor's degree in a related field with 5 years of experience in Quality Assurance.
The predicted salary is between 72000 - 88000 $ per year.
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.
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
Duties and responsibilities include:
- 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
- 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 is required. 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 is essential. Solid working knowledge of FDA, Health Canada, and EMA GXP regulations, and the interpretation and application of these regulations to the work environment is necessary.
The ability to be detail and goal oriented, focused on teamwork 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 is mandatory.
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.
Specialist I, Quality Assurance in Winnipeg employer: Emergent BioSolutions, Inc.
Emergent BioSolutions is an exceptional employer that prioritizes the well-being of its employees while delivering vital public health solutions. With a strong commitment to professional growth, a supportive work culture, and competitive benefits, including flexible work arrangements, employees are empowered to thrive in their roles. Located in a dynamic environment, the Analyst I position offers the chance to collaborate with passionate professionals dedicated to making a meaningful impact on communities worldwide.
Contact Details:
Emergent BioSolutions, Inc. Recruitment Team
