Specialist I, QA Operations

Emergent Biosolutions•Winnipeg, MB

About The Position

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.

Requirements

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.
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.

Nice To Haves

Experience using electronic quality systems, document management systems, training systems, or ERP/material management systems is preferred.

Responsibilities

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.
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.
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.
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.
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.
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.
Serve as a QA representative contact point for CMOs and review or approve deviations, CAPAs, change controls, and executed batch records supporting lot release.
Represent QA Operations on project teams and in interdepartmental meetings, and support training and mentoring of QA Associates.