Microbiologist II

Job Description

Reporting to the Microbiology Manager, the primary purpose of the role is to perform microbiological testing of raw materials, work-in-process, and finished products, while maintaining compliance of laboratory standard operating procedures.

• Develop microbiological test methods and method validations.
• Perform microbiological testing of raw materials, work-in-process, and finished product for product approval and release.
• Prepare protocols, final reports, and test methods related to the development and validation of microbiological methods.
• Perform growth promotion of media and maintenance of bacterial cultures.
• 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.
• 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.
• Avoidance of deviation from standards and reporting any deviations to supervisor.
• Interact and coordinate activities with other departments and external vendors to support and meet the facility goals and objectives.
• Aid in the review of test data and write/update Standard Operating Procedures (SOPs).
• Train team members in microbiology and chemistry laboratories as required.
• Ensure proper handling and disposal of biohazard material in compliance with OSHA and Standard Operating Procedures.
• Compose and assist with quality systems documentation such as failure investigations, CAPA, calibration, changes control, etc.
• Compose microbiological trending reports and protocols.

Qualifications

• B.S. in Microbiology, Biology, Life Sciences, or related field
• 2+ years of practical laboratory experience in a manufacturing environment
• Experience with general documentation practices and GMP compliance with data entry forms with specific attention to details
• 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
• Knowledge of cGMP’s and understand the pharmaceutical industry expectations
• Intermediate proficiency in MS Office (i.e. MS Word, MS Excel, Access, Outlook)