Specialist I, QA Operations

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 Specialist I, QA Operations supports the Winnipeg site by providing quality oversight for lot release, operational compliance, product distribution, deviations, CAPAs, change controls, non-conformances, quality systems, and CMO-related activities. This role coordinates and performs QA review and approval activities, supports timely resolution of quality issues, and partners with cross-functional teams to maintain GMP compliance and inspection readiness. The Specialist contributes to the manufacture and distribution of safe, compliant products in accordance with regulatory requirements and Emergent procedures.

Responsibilities

Duties and responsibilities include:

• Lot, batch record, and raw material release: Monitor incoming batch records and raw material release documentation, coordinate QA Associate review assignments, maintain review schedules, resolve discrepancies, confirm regulatory and country allocation requirements where applicable, compile lot and raw material release metrics, and support or perform QA release activities for intermediate product lots and raw materials.

• Quality oversight of operations: Provide QA oversight and support for operational activities, including coverage beyond core working hours as required, to promote compliance with GMP requirements, good documentation practices, and approved procedures.
• Commercial and clinical product distribution: Monitor shipment review requests, assign reviews to QA Associates, communicate shipment status and priorities to internal stakeholders, verify applicable quality agreement and contract requirements, and support QA approval of product shipments.
• Deviation, CAPA, and change control management: Own and manage deviations, CAPAs, and change controls assigned to QA Operations, including assessment, investigation execution, product impact assessment, root cause analysis, CAPA development, change implementation support, effectiveness considerations, timely closure, summaries, and QA Operations reports and metrics.
• Non-conformance review: Assign and support QA review and assessment of non-conformances, including SCAR, lookbacks, and returned product, and ensure related assessments, investigations, approvals, and timelines are completed appropriately.
• Quality systems and continuous improvement: Participate in quality system improvement initiatives, perform assessments or gap analyses as required, and prepare ad hoc, monthly, and quarterly quality reports and metrics for QA Operations.
• CMO quality management: Serve as a QA representative contact point for CMOs and review or approve deviations, CAPAs, change controls, and executed batch records supporting lot release.

• Cross-functional support and training: Represent QA Operations on project teams and in interdepartmental meetings, and support training and mentoring of QA Associates.

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

• Bachelor of Science in a related discipline with a minimum of 5 years of relevant experience in Quality Assurance, Quality Control, manufacturing, or an equivalent combination of education, skills, and experience.
• Strong working knowledge of GMP/GXP requirements and applicable regulatory expectations, including FDA, Health Canada, and EMA regulations, as they apply to pharmaceutical or biologic manufacturing and quality operations.
• Experience with QA review and approval activities, including batch record review, lot release, raw material release, shipment review, deviation/CAPA/change control management, and non-conformance assessment.
• Demonstrated understanding of good documentation practices, data integrity principles, product impact assessments, root cause analysis, CAPA development, change control execution, and timely quality event closure.
• Experience using electronic quality systems, document management systems, training systems, or ERP/material management systems is preferred.
• Ability to prioritize multiple quality deliverables, adapt to changing business needs, and make sound decisions in a GMP-regulated environment.
• Strong written and verbal communication skills, with the ability to collaborate cross-functionally, influence without direct authority, and build credibility with internal and external stakeholders.
• Ability to work effectively both independently and as part of a team.

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.