Microbiologist

Overview

Reporting to the Microbiology Manager, the primary purpose of the Microbiologist I is to perform routine release testing of raw materials and finished products, while maintaining compliance of laboratory standard operating procedures.

Business: Pharma Solutions

Department: Microbiology (MQC)

Location: Lexington

This position reports to the Microbiology Manager.

Days

• Perform microbiological testing of raw materials, work-in-process, and finished product for product approval and release.
• Perform and document environmental monitoring of the facilities and water systems in compliance with Standard Operating Procedures, as needed for cross-functional support.
• Maintain environmental monitoring trend data to drive continuous improvements, identify trends and draw conclusions.
• Provide support to facility to resolve nonconformance issues and identify corrective and preventative actions as related to environmental monitoring excursions.
• Complete environmental monitoring and laboratory related investigations and properly document results.
• Perform LAL, water analysis (as needed), growth promotion, gram staining, identification of microorganisms and other microbiological testing.
• Maintain GMP/GLP documentation relevant to the duties and responsibilities assigned.
• Maintain laboratory instrumentation required for testing and cleanliness of the laboratory per SOP guidelines.
• Maintain and track assigned testing activities to completion.
• Assist in the review of test data and report any deviations to supervisor.
• Assist management in writing/updating Standard Operating Procedures (SOPs).
• Participate in projects involving the Quality Control and/or Microbiology departments.
• Train team members in microbiology and chemistry laboratories.
• Handle and dispose of biohazard material in compliance with OSHA and Standard Operating Procedures.
• Perform other related duties as required.

• B.S. in Microbiology, Biology, Life Sciences, or related field
• Minimum 1 year of practical laboratory experience, preferably in a manufacturing environment
• Working knowledge and practical experience with good laboratory practices in a microbiology lab environment and competency with microbiology techniques such as Gram staining, isolation plating, media preparation and microorganism identification methods.
• Experience with common microbiology lab instrumentation is a requirement, especially with autoclaves, air samplers, light microscope, biohazard cabinets and water purification system
• Practical hands on experience with basic lab equipment such as pH, balances, water baths and other equipment common to microbiology methods
• Must understand basic lab safety, bio-hazard and chemical waste disposal practices
• Experience with general documentation practices and GMP compliance with data entry forms with specific attention to details.
• Knowledge of cGMPs and understand the pharmaceutical industry expectations.
• Intermediate proficiency in MS Office (i.e. MS Word, MS Excel, Access, Outlook)