Job Description
Provide technical expertise and project management oversight of all company microbiology systems to ensure effective, compliant processes to eliminate adverse microbiological effects on product. Includes environmental monitoring and product testing according to PMRS and international regulatory requirements (USP/NF, EP). Author necessary validations for processes and manage their execution.
Primary Duties:
Scheduling and performing all microbiological testing including:
· Environmental Monitoring – Viable and Non-Viable
· Compressed Air Monitoring
· Water Sampling/Testing – Bioburden, Total Organic Carbon, Conductivity
· Microbial Enumeration Testing
· Antimicrobial Effectiveness Testing
· Protocol and Report Preparations
· Departmental SOP Revisions
· Water System Monitoring and Maintenance
· Microbial Characterizations – Gram Stains
· Media Preparation and Growth promotion
· Glassware, Equipment, and Laboratory Maintenance
· Water Activity Testing
As needed, the employee will also contribute in the analytical chemistry departments, performing a variety of wet chemistry and instrumental analysis per USP/NF/EP. Also, may perform sampling of raw materials in GMP environment and cleaning verification.
Keys to Success
· Must be a self-starter with excellent judgment and communication skills
· Capable of working with minimal oversight
· Create value for the position, department and company
· Must understand and participate in prevention and be able to improve systems and procedures as applicable
· Must be able to work in a fast paced and changing environment and know how to prioritize activities appropriately
Education & Experience Requirements
· Minimum of a Bachelor’s Degree in Microbiology or related science field to an accredited US college or university
· Previous Microbiology Lab experience, test method and process validation experience is required
· Minimum of 1+ years in a cGMP testing environment
· Salaried employees are compensated for a 50 hour work week
· Background and Credit Check required as part of the hiring process