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 MicrobiologyMain Responsibilities:
Knowledge, Skills & Technical Expertise:
- 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
- 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
Measurement of Performance:
- Work under general supervision to meet company goals
- 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.