Senior Specialist QA - I (Assistant)

About the role

The Fountain Group is currently seeking a Senior QA Specialist for a prominent client of ours. This position is located in Durham, NC.

Pay & schedule

• Pay: $28-31.41/hr
• Shift: Sun-Thurs; 8:30am-5:00pm or Tues-Sat; 8:30am-5:00pm
• 12-month assignment with possibility for extension or conversion based on performance and budget

Responsibilities

• Perform microbiological, chemical, and analytical sampling and testing to support in-process and finished product release
• Conduct sterility testing, residual moisture detection, and average cell dry weight testing
• Perform environmental monitoring, including active air, surface, and water sampling, and evaluate environmental microbiological samples
• Evaluate test data, troubleshoot technical and operational issues, and support process improvements
• Prepare technical reports and contribute to interdepartmental committees and quality improvement projects
• Collaborate with Production, Quality Assurance, Validation, Facilities, and external resources to support manufacturing operations
• Make routine quality decisions on the shop floor in accordance with established policies and procedures
• Communicate results, ask questions, and escalate complex issues to the Quality Control Manager as needed

Qualifications

• Associate’s degree required; Bachelor’s degree in Microbiology, Biology, Chemistry, Biochemistry, or a related scientific discipline preferred
• Experience with microbiological testing, environmental monitoring, and/or analytical testing in a pharmaceutical, biopharmaceutical, or other regulated manufacturing environment
• Knowledge of GMP, quality control procedures, and applicable regulatory requirements
• Familiarity with sterility testing, environmental monitoring, and in-process or finished product release testing
• Strong attention to detail and ability to accurately document, evaluate, and report laboratory data