Job Description

Business: Pharma Solutions
Department: Microbiology (MQC)
Location: Lexington

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.

Reporting Structure

This position Reports to the Microbiology Manager.

Shift

Days

Key Responsibilities:

• 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
• Perform and document environmental monitoring in compliance with Standard Operating Procedures.
• 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

Qualifications:

• B.S. in Microbiology, Biology, Life Sciences, or related field

• Must have a 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 cGMP’s and understand the pharmaceutical industry expectations.
• Intermediate proficiency in MS Office (i.e. MS Word, MS Excel, Access, Outlook)