- Receive and log into the laboratory all samples required for microbiological support.
- Media preparation and growth promotion.
- Environmental monitoring of production areas.
- Perform antibiotic assay analysis for raw materials, finished product, and stability samples.
- Perform out-of-specification investigations and all required documentation per cGMPs and company procedures.
- Support Continuous Improvement program throughout the company.
- Operate, troubleshoot, and maintain instrument used in the laboratory, such as UV-VIS, autoclave, and TOC analyzer.
- Interface with FDA compliance officers during facility inspections.
- Review and revise procedures as required to ensure compliance.
- Accurately document all data in compliance with GMP.
- Develop and validate testing methods used in routine analysis of incoming raw materials and finished products.
- Provide technical support in the area of microbiology to the Manufacturing and Validation departments.
- Water sampling and testing as per the schedule.
- Assist in writing validation protocols, project reports, updating laboratory documentation, SOPs, and test methods.
- Other tasks as assigned.
- 1-5 years of microbiology experience.
- Practical experience with GMPs within a regulated environment.
- Preferably experience in an FDA, Canadian Health, and or EU regulated Pharmaceutical manufacturing environment
- Bachelors Degree in related science field.
- Working knowledge and troubleshooting of autoclaves and TOC analyzers.
- Must possess excellent communication skills for liaising and communicating with internal departments.
- Strong problem identification and problem resolution skills.
- High level of proficiency with Microsoft Office.
- Good written skills.
- Knowledge of USP methodologies
- Knowledge and experience with continuous improvement programs
- Highly motivated and self- directed capable of multi- tasking, and able to work with minimal supervision.
- Extremely detail-oriented and analytical thinker.
- Strong work ethic and positive team attitude.