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System One Services Microbiology Supervisor in Baltimore, Maryland

Microbiology SupervisorBaltimore, Maryland

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Type:Direct-Hire

Category:Scientific & Clinical

Job ID:185616

Date Posted:02/02/2021

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.

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