Senior Specialist QA - I (Assistant)

The Fountain Group; Durham (NC); On-site; USD 39,000 - 43,000; Full time

Benefits offered by this job

Referral Bonus

Job summary

The Fountain Group seeks a Senior QA Specialist for a Durham, NC site. The role focuses on microbiological, chemical, and analytical testing to support in-process and finished product release.

You will perform environmental monitoring, evaluate test data, and collaborate with Manufacturing, QA, Validation, and Facilities to drive quality improvements. This is a 12-month assignment with potential extension based on performance and budget.

Qualifications

• Associate's degree required; Bachelor's in a related science preferred.
• Experience with microbiological and environmental testing in regulated environments.
• Knowledge of GMP and quality control procedures.
• Ability to document and report laboratory data accurately.

Responsibilities

• Perform microbiological, chemical, and analytical sampling and testing for product release.
• Conduct sterility testing, residual moisture, and cell weight testing.
• Perform environmental monitoring including air, surface, and water sampling.
• Evaluate data, troubleshoot issues, and support process improvements.
• Prepare technical reports and contribute to quality projects.
• Collaborate with Production, QA, Validation, Facilities, and external resources.
• Make routine quality decisions on the shop floor per policies.
• Communicate results and escalate complex issues as needed.

Skills

Microbiology testing

Environmental monitoring

Analytical testing

GMP knowledge

Data documentation

Education

Associate's degree

Bachelor's degree in Microbiology/Biology/Chemistry

Job description

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 escalat[?] 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.

Benefits:

• Referral Bonus for any candidate hired.