KEY DUKEY DUTIES
- Performs and ensures that microbiology testing for raw materials and finished product is completed in a timely and accurate manner to meet product manufacturing requirements for manufacture and release.
- Ensures that all work is carried out in compliance with company Safety policies, Good Manufacturing Practices (GMP/GLP) and Standard Operating Procedures (SOPs) and meets housekeeping and cleanliness standards.
- Reviews all documentation for accuracy and completeness and ensures that it’s in compliance with current GMPs/GLP, Good Documentation Practices, SOPs and company policies
- Specialize in the Aseptic manufacturing environmental monitoring (EM) and various microbial testing and performs testing, system suitability tests and EM and provides training and feedback to the Microbiologists as required.
- Specialize in various microbial testing and performs testing and training for Sterility test, BET, Bioburden, GPT, Microbial Assays and Identification and other related microbial testing
- Initiate, execute and participate as needed in the preparation of investigations relating to deviations in raw materials, finished products and environmental monitoring. Provides technical support in evaluating incidents and interventions during filling operations.
- Communicates to Management any corrective actions that need to be taken in response to excursions in controlled environmental conditions and makes recommendations.
- Schedules regular maintenance on equipment in coordination with lab work demands.
- Performs and participates in technical studies for research and development projects, and new product development projects as assigned or scheduled.
- Performs, executes, and participate in microbiology validations and other projects and offers technical expertise for Microbiology investigations. Participates and assists validation in coordination of activities for media fills and personnel gown qualification.
- Responsible for Quarterly and Annual Environment monitoring trend reports, Microbial data deviation trend reports, and water trend reports as assigned
Revises laboratory Standard Operating Procedures as requiredQUALIFICATIONS:
- Three (3) – five (5) years’ relevant experience in a regulated pharmaceutical industry including Quality Assurance
- BSc degree in Microbiology, Biology, or related field
- Proficient in Aseptic environment monitoring and various microbial testing. A subject matter expert that others can call upon for support and counsel.
- A working and actionable knowledge of cGMP, Quality Systems, Drug Regulatory Affairs, Stability protocols and systems, manufacturing, and packaging processes
- Strong communications skills. Must possess apparent specialist qualities to be able to interact and communicate with all levels internally and externally comfortably and successfully
- Ability to manage time efficiently and work without direct supervision. Manage complexity at a capable level.