Job Description

Business: Pharma Solutions


Department: Microbiology (MQC)


Location: Lexington, KY

Job Overview

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.

Reporting Structure

Directly reports to Supervisor Microbiology

Key Responsibilities

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. Assist in the review of test data and report any deviations to supervisor. Interact and coordinate activities with other departments and external vendors to support and meet the facility goals and objectives 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 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 Perform other related duties as required

Education Requirements

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

Work Experience

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.

Functional or Technical Skills

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)