The Microbiologist performs technical microbiological and Environmental Monitoring duties to support manufacturing activities and will be directly reporting the to Supervisor/Manager of QC Microbiology and to the Associate Director/Director of QC Microbiology
Complies with all cGxP and safety requirements and laboratory Standard Operating Procedures
Perform Environmental Monitoring associated with manufacturing area. Monitoring includes total particulate monitoring, viable air sampling, surface plating of the classified areas, and personnel monitoring.
Collect WFI, Pure Steam and Purified Water samples associated with the manufacturing areas and subsequently test the samples for presence of bioburden and endotoxin.
Perform routine laboratory duties to support the overall function of the microbiology laboratory such as preparation of autoclave loads, biosafety cabinet, growth promotion, microbial identification and laminar flow hood cleaning and maintenance.
Perform routine biological laboratory assays such as pH and buffer preparation, BET, Bioburden, GPT - as specified in appropriate SOPs.
Perform Sterility Testing and must be familiar with Isolator technology
Develop and perform validation methods
Support Technical Services with Qualification studies
Knowledge, Skills & Technical Expertise:
Must be able to work in a controlled environment requiring specified gowning
Must be able to work overtime as needed
Must be able to work weekends as needed
Understanding of intermediate Microbiology and Aseptic Behavior
Work under general supervision to meet company goals
Measurement of Performance:
Maintain a Positive, professional attitude toward work and willingness to cooperate with peers and supervisors and to contribute to a project team
Demonstrate timeliness and accuracy in completion of projects and paperwork
Contribute to right first time and on-time delivery of assigned projects
Demonstrated understanding and adherence to regulatory policies, safety procedures and cGMPs
Ability to succeed in a team-oriented environment under very dynamic conditions
Bachelors of Microbiology or Biological Sciences and five to seven (5-7) years of related laboratory experience in the pharmaceutical industry; or an equivalent combination of training and experience.
Cleanroom/Aseptic Area experience preferred
Must be detail oriented, conscientious and have a high reading comprehension skill.