Microbiologist I

Duration: 06 Months+

• Ensure compliance with all company policies and procedures and appropriate regulations, including FDA and ISO 9001, ISO 13485, CMDR and the Medical Device Directive.
• Perform and document in-house microbiological testing on all in-process and finished products to comply with acceptance requirements.
• Perform LAL, water analysis, growth promotion, gram staining, identification of microorganisms and other microbiological testing.
• Perform and document environmental monitoring in compliance with Standard Operating Procedures.
• Report any equipment and testing deviations to the Supervisor.
• Submit samples for shipment to third party labs when necessary.
• Maintain GMP/GLP laboratory notebooks and documentation relevant to the duties and responsibilities assigned.
• Maintain laboratory instrumentation required for testing.
• Assist with proper execution of laboratory Alert/Action (AA) and Out-of-Specification (OOS) investigations.
• Interact and coordinate activities with other departments and external vendors to support and meet the facility goals and objectives, especially related to environmental monitoring.
• Assist management in updating Standard Operating Procedures (SOPs).
• Perform data entry and assist with trend reporting as needed.
• Train team members in Microbiology department.
• Provide gowning training and qualification to operators, cleaning and other essential staff.
• Handle and dispose of biohazard material in compliance with OSHA and Standard Operating Procedures.
• Perform other related duties as required.

Education:

• Bachelor's degree required.

Shift: 1st Shift