Specialist I, QA Compliance

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 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.

ESSENTIAL FUNCTIONS

Reasonable accommodations will be made to enable individuals with disabilities to perform the essential functions.

Quality Systems:

• 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.

Compliance and Regulatory:

• 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.

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’s Degree in Biological Science or similar scientific field.
• Minimum of 5 years of parenteral pharmaceutical cGMP Quality experience with increasing responsibilities.
• 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.
• 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.

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.