Compunnel
Microbiology Lab Associate
Compunnel, Morrisville, NC, United States
Job Summary
The Microbiology Lab Associate is responsible for performing microbial testing of finished goods, bulk products, and raw materials, ensuring compliance with USP <61> microbial enumeration and USP <62> specified microorganisms using rapid microbial testing methods.
The role involves documentation, quality control support, and assisting in investigations related to quality issues.
Key Responsibilities
The Microbiology Lab Associate is responsible for performing microbial testing of finished goods, bulk products, and raw materials, ensuring compliance with USP <61> microbial enumeration and USP <62> specified microorganisms using rapid microbial testing methods.
The role involves documentation, quality control support, and assisting in investigations related to quality issues.
Key Responsibilities
- Perform microbial testing on finished goods, bulk, and raw materials.
- Accurately document test results and information in real time.
- Support bulk and raw material sampling, testing, and release processes.
- Conduct additional testing including sensory, pH, viscosity, and penetration.
- Review test data and perform release transactions in SAP.
- Assist production lines by addressing quality-related questions and ensuring compliance with quality standards.
- Support investigations of quality issues, including documentation of OOS (Out of Specification), NCR (Non-Conformance Report), and Deviations.
- Prepare and sterility test media for raw material testing.
- Review Chain of Custody and Line Clearance forms before distributing samples for testing.
- Assist with laboratory cleaning and inventory management of testing supplies.
- Create, revise, and review SOPs, Job Aids, and One Point Lessons.
- Contribute to quality projects as assigned.
- Associate’s Degree in a related field, or two years of relevant work experience in manufacturing (pharmaceutical, food, or cosmetics preferred).
- Proficient in Microsoft Word and Excel.
- Demonstrated analytical reasoning and troubleshooting skills for testing equipment.
- Knowledge of microbiology processes, including plating and microbial testing methods.
- Experience using SAP and Outlook.
- Familiarity with Warehouse Management Systems, specifically SAP.
- Ability to operate lab equipment such as Neogen Soleris, autoclave, pH meter, viscometer, penetrometer, and TOC analyzer.
- Understanding of GMP, GLP, GDP, and safety regulations.