Microbiologist II
Health Wealth Safe · Brea, CA · 2 mo ago
AnalystFull-time
About the Role
This position involves executing quality control tasks to ensure product safety and compliance in a pharmaceutical manufacturing environment.
Responsibilities
- Perform microbiological testing such as bioburden, endotoxin, microbial enumeration, Gram stain analysis, and growth promotion on raw materials, in-process, and finished goods.
- Coordinate sample submissions to external testing facilities and maintain laboratory inventory.
- Develop, optimize, and validate microbiological test methods; generate protocols, review data, and prepare reports.
- Revise SOPs, test methods, and procedures to ensure compliance with regulatory standards.
- Participate in validation activities involving aseptic processes and support environmental monitoring in cleanroom environments.
- Perform tests on high purity water samples and analyze environmental monitoring plates, including microbial identification.
- Assist in data review, trending, and report generation, and train new personnel.
- Adhere to FDA regulations and cGMP/cGLP documentation practices.
- Support aseptic process simulations, sterilization, and container integrity testing.
Requirements
- Bachelor’s degree in Microbiology or related field.
- 2-4 years of relevant industry experience.
- Ability to work independently and prioritize tasks effectively.
- Strong organizational, interpersonal, and communication skills.
- Proficiency in MS Office and technical document reading.
- Physical ability to wear PPE, handle materials, and lift up to 25 pounds.