Quality Control Analyst (Microbiology)
oxfordbiom•Durham, NC
•Onsite
About The Position
OXB is seeking a Quality Control Analyst to join their Quality Control team at their new commercial-scale viral vector facility in Durham, North Carolina. This role involves performing microbiological testing, environmental monitoring, data review and trending, and supporting GMP operational systems to ensure a compliant Quality Control laboratory. The analyst will collaborate with Manufacturing, Facilities, Quality Assurance, and other key functions.
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
Mid Level
