Specialist I, QA Compliance

Emergent Biosolutions • Winnipeg, MB

6d

About The Position

The Specialist I, QA Compliance (Plasma Operations) is responsible for providing Quality Assurance oversight of plasma-related activities in support of hyperimmune pharmaceutical manufacturing. This role ensures that plasma sourcing, handling, processing, and associated quality systems comply with current Good Manufacturing Practices (cGMP), regulatory requirements, and internal quality standards. The Specialist I also plays a key role in maintaining inspection readiness, supporting regulatory and customer audits, and ensuring the effective execution of quality systems. This position partners cross-functionally to support product quality, patient safety, and continuous improvement.

Requirements

• Bachelor’s Degree in Biological Science or similar scientific field.
• Minimum of 5 years of parenteral pharmaceutical cGMP Quality experience with increasing responsibilities.
• Must have a full understanding and knowledge of cGMPs and EU Regulations.
• Must have Change Control, SOP, investigation and protocol writing skills and demonstrated ability to critically evaluate content and criticality of information.
• Must be able to prepare reports for internal metrics and technical content; and prepare reports and data summaries for FDA review.
• Proficiency in MS Office products, SAP or comparable word-processing and spreadsheet skills are required.

Nice To Haves

• Previous experience working with FDA (CBER) and participating in regulatory agency inspections desired.
• Industry certifications or diplomas in Quality Management, Auditing, and/or Quality Systems considered an asset.

Responsibilities

• QA Oversight of Plasma Operations including: Supplier & Plasma Source Compliance, Lookbacks, and Shipping excursions.
• Supports internal, customer, and regulatory inspections with planning, scheduling and conducting quality system audits with minimal.
• Analyze multiple, documents, records and observations, as well as interview personnel, to determine compliance to GxP regulations. Strong judgment, critical analysis, critical thinking skills required. Ability to assess strengths and gaps of systems and processes. Must be able to multi-task, consolidate and analyze multiple documents simultaneously.
• Define, prepare, and communicate metrics, trends, and data summaries to senior management, as needed.
• Writes and revises Quality Technical Agreements.
• Work across all disciplines and functional areas to ensure that the site maintains a state of inspection readiness.
• Ensure that cGMP requirements and quality standards are recognized, understood and maintained across the site.
• Provide quality guidance to continuous improvement projects, product development, validation and transfer initiatives.
• Identify opportunities for continuous improvement in compliance, business, and safety practices; then plan and implement improvements as appropriate.
• Keep abreast of changes to quality regulations and guidelines, advising management of any business implications of these changes.
• Represent Quality Assurance and Emergent during FDA, EU and other regulatory agency inspections and customer relation activities with CDC, BARDA, DoD and HHS.
• Complete FDA inspection response reports, monthly response updates and coordinated response and gap analysis teams.

Benefits

• highly diverse career opportunities
• a supportive culture
• competitive salaries
• flexible work arrangements
• an extensive benefits package

What This Job Offers

• Job Type: Full-time
• Career Level: Entry Level