Specialist I, Quality Assurance-WIN

Job summary

Manage deviations and corrective and preventive actions, including investigations, product impact assessments, root cause analysis, and review and approval of records. Support quality systems and improvement projects, participate in inspections and audits, and represent Quality Assurance in cross-functional teams while ensuring GMP and procedural compliance.

Job details

Preparedness today, safer tomorrow. Emergent is a leading public health company that delivers protective and life-saving solutions tocommunities 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 ManagementNon-ConformancesQuality Systems reports and improvement projects Change actions review and approvalCompliance with GMP requirements, good documentation practices and adherence to Emergent’s procedures Duties and responsibilities include:Deviation and CAPA ManagementDeviation administration through consultation, review, assessment and participation in deviation investigationsEnsuring complete investigation including product impact assessment and root cause analysisEnsures CAPA address the root causes of deviations and prevent future recurrencePerforming deviation investigations Preparation of deviation summariesDeviation system reportsReview and approval of Deviations and CAPAsQuality Systems reports and improvement projects Inspection/Audit ManagementParticipate as a team member during regulatory inspections or customer auditsAct as QA representative on project teams or in meetings, and be able to represent QA at interdepartmental meetingsAid in training of QA SpecialistsQuality Systems reports and improvement projects Inspection/Audit ManagementParticipate as a team member during regulatory inspections or customer auditsAct as QA representative on project teams or in meetings, and be able to represent QA at interdepartmental meetingsAid 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 & SkillsA 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.

What you’ll do

Manage deviations and corrective and preventive actions, including investigations, product impact assessments, root cause analysis, and review and approval of records. Support quality systems and improvement projects, participate in inspections and audits, and represent Quality Assurance in cross-functional teams while ensuring GMP and procedural compliance.

Requirements

Requires a bachelor's degree in a related discipline and at least five years of experience, or equivalent skills and experience, along with advanced technical knowledge in a scientific discipline, Quality Assurance, or Quality Systems. Candidates need thorough pharmaceutical manufacturing and analytical process knowledge, working knowledge of FDA, Health Canada, and EMA GxP regulations, strong communication and collaboration skills, and successful completion of a criminal record check.

Benefits

• Competitive Salaries
• Flexible Work Arrangements
• Extensive Benefits Package

Listed skills

• Teamwork · Preferred
• Regulatory Compliance · Preferred
• Quality Control · Preferred
• Communication · Preferred
• Root Cause Analysis · Preferred

Other relevant skills

Identified from the job description. Confirm important requirements above.

• Deviation Management
• CAPA Management
• Root Cause Analysis
• Product Impact Assessment
• Quality Systems
• GMP Compliance
• Good Documentation Practices
• Regulatory Compliance
• Pharmaceutical Manufacturing
• Quality Control
• Supplier Quality Management
• Audit Management
• Inspection Support
• Technical Writing
• Communication
• Teamwork
• Supplier Quality Engineering
• Deviation Investigations
• Auditing
• Management
• Good Manufacturing Practices
• Corrective And Preventive Action (CAPA)
• Impact Assessment
• Negotiation
• New Product Development
• Pharmaceuticals
• Quality Assurance
• Relationship Building
• Safety Assurance
• Verbal Communication Skills
• Investigation
• Goal-Oriented

Job areas

• Manufacturing
• Healthcare
• Science & Research
• Quality Assurance Specialist
• Product Graders and Testers (except Foods and Beverages)
• Inspectors, Testers, Sorters, Samplers, and Weighers

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