Quality Control Analyst (Microbiology)
About The Position
Quality Control Analyst – Microbiology Join Us in Changing Lives At OXB, our people are at the heart of everything we do. We’re on a mission to enable life-changing therapies to reach patients around the world—and we’re looking for passionate individuals who embody our core values every day: Responsible, Responsive, Resilient, and Respectful. Following the expansion of our US footprint with the acquisition of a new commercial-scale viral vector facility in Durham, North Carolina we have some new opportunities to join us. We’re currently recruiting for a Quality Control Analyst to join our Quality Control team. In this role, you will perform microbiological testing, environmental monitoring, data review and trending, and support the implementation of GMP operational systems to ensure a compliant Quality Control laboratory. You will collaborate closely with Manufacturing, Facilities, Quality Assurance, and other key functions as needed.
Requirements
- Minimum BS in Microbiology or other related field
- 3+ years of experience in a cGMP/GxP environment is preferred
- Hands on experience with environmental monitoring, facility qualification, bioburden, endotoxin, and other Microbiological methods
- Demonstrate a strong initiative and scientific leadership
- Direct experience in authoring and review/approval of SOPs
- Superb organizational, analytical, and communications skills and “do-what-it-takes” attitude
- A passion for addressing the critical unmet medical needs of patients
- Self-directed individual who is able to work with limited direction in a fast-paced, goal-oriented Environment
Responsibilities
- Perform cGMP microbiological testing, including endotoxin, bioburden, and environmental monitoring, among others.
- Review and evaluate raw data for accuracy and compliance, performing peer and technical reviews, as well as sample authorization.
- Author, review, and approve SOPs, policies, and technical reports in alignment with quality and regulatory standards.
- Lead laboratory deviations and investigations (IA, OOS, AR), including assessment, protocol/report authoring, and investigation closure with minimal guidance.
- Lead or support equipment validation activities, including authoring, execution, review, and approval.
- Implement and maintain operational systems such as equipment maintenance/calibration, alarm monitoring, sample handling/tracking, data integrity, cGMP documentation, LIMS management, laboratory audits, and method training.
- Execute phase-appropriate test method validation protocols as required.
- Contribute to regulatory filings and inspections, providing relevant data and documentation support.
- Drive continuous improvement initiatives, including CAPA development and implementation.
Benefits
- Competitive total reward packages
- Wellbeing programs that support your mental and physical health
- Career development opportunities to help you grow and thrive
- Supportive, inclusive, and collaborative culture
- State-of-the-art labs and manufacturing facilities
- A company that lives its values: Responsible, Responsive, Resilient, Respect
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What This Job Offers
Job Type
Full-time
Career Level
Entry Level
