- 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.
- 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.
- Assist in writing validation protocols, project reports, updating laboratory documentation, SOPs, and test methods.
Please note that this job description is not exhaustive, and the role holder may be required to undertake other relevant duties commensurate with the grading of the post. Activities may be subject to amendment over time as the role develops and/or priorities and requirements evolve.
- 1-5 years of microbiology experience.
- Practical experience with GMPs within a regulated 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.
- 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.
- Preferably experience in an FDA, Canadian Health, and or EU regulated Pharmaceutical manufacturing environment.
- Knowledge of USP methodologies.
- Knowledge and experience with continuous improvement programs.
Bimeda is a leading global innovator, manufacturer and marketer of veterinary pharmaceuticals and animal health products and has over half a century’s experience in providing science-driven solutions to optimize the health, wellbeing and productivity of the world’s animals.
Bimeda’s global innovation program sees six state-of-the art R&D centers across four continents collaborate on an enviable product development pipeline which anticipates the ever-evolving needs of the animal health industry.
Bimeda’s nine manufacturing facilities across seven countries allow the company to manufacture a broad range of preventative, curative and nutritional products including sterile injectables, vaccinations, nutritional boluses, feed additives, tablets, water-soluble powders, pastes and non-sterile liquids.
Globally, the company focuses on the development, manufacture and commercialization of quality Bimeda-branded products while also being the partner of choice for contract manufacturing and R&D services for prominent companies within the animal health industry.
More Info at www.bimedacareers.com