Microbiologist I

The Microbiologist I will provide to the QC Microbiology Laboratory as pertaining to the respective responsibilities. Performs functions such a executing laboratory testing for in-process and finished good products, water, stability studies, and validation studies as well as performs environmental monitoring. This position is responsible for operating in compliance with all applicable procedures and policies.

ESSENTIAL DUTIES AND RESPONSIBILITIES

To perform this job successfully, an individual must be able to perform each essential duty satisfactory.

• Ensure compliance with all company polices 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 wih 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.
• 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.

• Bachelor's degree, in Microbiology or Biology preferred
• 0-3 years of relevant GMP/GLP laboratory experience in regulated industry preferred
• Capable of effective written and verbal communication
• Must be able to work independently with minimal supervision
• Knowledge of MS Office Suite