Quality Control Analyst I

Job Description:
• Use laboratory instrumentation including but not limited to: analytical equipment, autoclaves, and incubators.

• Perform assays requiring precise analytical skills and understanding of biology and chemistry principles.

• Conduct biological, chemical and physical analyses on raw materials, initial, in-process and final products, and samples collected from environmental monitoring.

• Maintain data integrity and ensure compliance with company SOPs and specifications, FDA, GLP, QSR and CGMP regulations.

• Investigate nonconformances and write exception documents.

• Handle multiple tasks concurrently including testing, special project / protocol testing in a timely and appropriate manner.

• Participate in functions involving teams, which impact production, increase efficiency, solve problems, generate cost savings and improve quality.

• Perform review of test data, which includes overall documentation practices (CGDP).

Perform release functions in LIMS or other computerized systems.

Job Requirements: May prepare monthly quality trend reports.

• Perform laboratory audits as required.

Audit and update, as required, plant SOPs.

• Perform test equipment, equipment maintenance and calibrations as required.

• May perform other duties as assigned.

• Experience in quality operations, biotechnology, pharmaceutical or similar GMP manufacturing environment is preferred but not required.

Education Bachelor’s Degree in Microbiology, Biology or Biological Sciences required.

Shift Details 08:00 AM to 05:00 PM