Senior Specialist QA - I (Assistant)

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.

The Fountain Group is currently seeking a Senior QA Specialist for a prominent client of ours. This position is located in Durham, NC. Details for the position are as follows:

• Pay: $28-31.41/hr.
• Shift: 
  • Sun-Thurs; 8:30am-5:00pm
  • 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. 

If you are interested in hearing more about the position, please respond to this posting with your resume attached.
Please forward this posting to any friends or colleagues as we do offer a Referral Bonus for any candidate hired.
 
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