Microbiology Supervisor

Title: Microbiology Supervisor
Location: Baltimore, MD
Type: Direct Hire. Competitive Salary with annual bonus and full benefits
Start date: ASAP

Responsibilities: Manages the Microbiology laboratory support of production by ensuring the timely release of manufacturing areas, utilities, raw materials, in-process, and finished products
Serves as the technical subject matter expert on microbiological assays and techniques
Defines and manages the activities of the Microbiology Laboratory to assure that all test samples meet the raw materials, intermediate, final product, and stability specifications
Provides expertise and troubleshoots microbiology related issues
Authors, reviews, and approves SOPs, validation protocols, investigations, and batch records specifications as they relate to this department
Work with the Microbiology staff to author Microbiology related deviations, CAPA, OOS, and OOL investigations
Responsible for cGMP compliance of the laboratory and personnel
Define the development needs in the Microbiology Laboratory
Represent microbiology in meetings with Production, Quality Assurance, Engineering, Regulatory Affairs, and other related departments
Provide industrial microbiology regulatory/technical guidance to site
Advises, recommends, and implements resolutions for quality problems and regulatory commitments to site management
Interact with other departments as required to define and/or verify the scope of work for a project; i.e. Provide testing services for validation work
Responsible for the scientific and managerial training for the staff to assure a competent, professional, and committed work force. Recommends promotions and salary increases as deemed necessary
Ensure the completion of projects within budget limits and time projections
Participate in and attend professional seminars, conferences, and conventions

Requirements:Bachelor's Degree in Microbiology/Biology or related field
Minimum of 5 years of experience, including supervisory responsibilities in Pharmaceutical industry with emphasis in aseptic processing, QC microbiology, environmental monitoring, water systems, cGMP, validation, and manufacturing processes
Must have previous hands-on experience with microbiological methods such as Bacteriostasis and Fungistasis, Enhancement and Inhibition, LAL, Sterility, and Bioburden Testing
Competent in the use of various computer programs of Microsoft Access and Excel
Excellent communication, documentation, and organization skills
In depth knowledge of FDA regulations pertaining to cGMPs, international regulations, and industry practices
Experience performing extensive investigations related to microbiology/biology issues

Joule, a System One division is a leader in specialized workforce solutions and integrated services. With more than 6,000 employees and roughly 50 offices throughout the U.S. we provide scientific, clinical, engineering, energy, IT, legal and administrative staffing services. For more than 40 years, we have delivered workforce solutions and integrated services to clients nationally.