We are actively seeking a Microbiology Analyst. This position is responsible for performing microbiological tests that support the release of intermediates and finished products. These include routine and non-routine microbiological tests on in-process and final container products, as well as environmental monitoring samples. This position also contributes to the completion of routine technical tasks.
Responsibilities include but not limited to:
- Preparation of Revenue and Capex Budget as per spent analysis project. Ensure financial prudence in resource planning, allocation and manage within approved budgets while building best in class quality processes and systems at site.
- Maintain quality system controls to ensure no critical and major market complaints.
- Ensure that all statutory and regulatory compliance are regularly monitored and is in a state of compliance as applicable.
- Take appropriate steps to reduce wastage and losses in the analysis process and build improved efficiency.
- Monitoring samples, in-process product samples, raw materials, and environmental monitoring (EM) samples.
- Count colony forming units (CFU) on Petri plates.
- Perform sterility testing on final products and raw materials.
- Perform Growth Promotion and Biological Indicator testing.
- Perform preparation of reagents, materials, and equipment used in microbiological testing in sterile environments, such as HEPA hoods.
- Maintain accurate and complete test records.
- Help maintain inventory by reporting needed supplies.
- Enter test results in the Laboratory Information Management Systems (LIMS).
- Maintain sample logs on a daily basis to ensure timely testing and tracking of all samples.
- Maintain Instrument Usage and Calibration Logs based on instrument usage during the preparation and testing of samples.
- Maintain current knowledge of regulatory and industry standards, trends and advancements.
- Preparation, review and approval of sampling matrix and hold time schedule Conducts and communicates results of lab investigations when test results fall outside pre-established specifications (OOS).
- Performs routine equipment maintenance.
- Performs maintenance of spare parts inventory, calibrations and supervises third party maintenance and repair when necessary.
- Establishes good working relation with contract laboratories.
- Supports in the development of methods transfer and validation, troubleshooting, cross validation, IQ/OQ protocols.
- Supports activities regarding audits of suppliers and contract labs in support of vendor certification program.
- Conducts statistical evaluation of the manufacturing and inspection process and training QC staff.
- Assures laboratory databases are maintained and accurate.
- Ensures control of laboratory documentation (Raw Material COA, testing instructions, testing.
- Ensure that all equipment is calibrated.
- Bachelor’s degree in Microbiology, or closely related scientific discipline.
- Degree in Microbiology is highly preferred.
- Laboratory experience is preferred.
- Pharmaceutical & FDA/GLP industry experience is preferred over academic laboratory experience.
- Microbiology laboratory skills and knowledge, such as aseptic techniques, is required.
- Demonstrated understanding of cGMPs, cGLPs, FDA regulations, and industry guidelines, as well as international regulatory guidelines.
- Ability to keep neat, accurate and complete records and logs.
- Must be proactive, results oriented, with a strong attention to detail.
- Self-starter with good work ethic and ability to work independently with minimum supervision and use good judgment, or as a contributing member of a team.
- Ability to manage multiple projects simultaneously, meet deadlines, and handle an ever changing, fast paced critical work environment.
- Strong organizational, analytical, troubleshooting and problem-solving skills. Ability to analyse details and perform structured decision-making on a daily basis.
- Excellent verbal and written communication.
- Must be able to read, write, and speak English.
- Strong interpersonal skills with ability to interact with all levels of personnel in a professional manner.
- Good computer skills with basic knowledge of Microsoft programs, particularly Outlook, Word, Excel, etc. Knowledge of LIMS (Laboratory Information Management System) is a plus.
Knowledge & Skills:
- Good communications skills, front runner, GMP trainer.