Microbiologist II

POSITION PURPOSE

Part of the Quality Control department that evaluates raw materials, other supplies and the finished, packaged product and ensures compliance to Good Manufacturing Practices. Provides support to the operations and manufacturing departments to ensure safe and effective finished product release. Essential Functions And Basic Duties The Microbiologist II is responsible for performing microbiological testing, analysis, and ensure results are appropriately processed with data integrity principles, in accordance with internal procedures and methods. Testing & Analysis Conduct routine testing for water, bulk pharmaceutical chemicals, drug products, and finished products. Provide assessment of results according to appropriate test methods and work instructions Perform method suitability testing on finished products using traditional methods according to procedures. Only document results and report appropriately Sampling and testing water, environmental air and surface. Report, analyze, and trend data. Conduct aseptic samplings for evaluation of compressed air and cleaning/sanitization processes Perform basic identification of microorganisms Prepares media used in the microbiological testing of bulk pharmaceutical chemicals, drug products and components. Perform growth promotion testing for purchased and prepared media Samples raw materials and/or finished products for microbial testing aseptically Assist in the maintenance and calibration and/or certification of laboratory equipment Train and qualify technicians and/or microbiologists on testing procedures and techniques, as well as oversee data generated into electronic or laboratory notebooks Perform review of generated data by microbiologists in a timely manner and ensure ALCOA principles are applied Collaborate with third party lab to ensure specifications and results are provided and processed appropriately Support LIMS or special projects specifically related to microbiology Able to write scientifically sound microbiology investigation reports, non-conformance evaluation and root cause investigations Write or update Standard Operating Procedures (SOPs) current to ensure compliance to regulatory standards Ensure that lab activities maintain compliance with current Good Manufacturing Procedures (cGMP), cleanliness and data integrity requirements at all times Prepares samples for shipment to external contract laboratory for microbiological testing Performs additional activities as assigned

PERFORMANCE MEASUREMENTS

Annual Goals and Objectives Training documentation Qualification for performing test methods Qualifications

EDUCATION/CERTIFICATION:

Bachelor’s degree in Biology, Microbiology, Chemistry or related science from an accredited college or university Required Knowledge Understand Current Good Manufacturing Practices (cGMP), Food and Drug Administration (FDA) Traditional microbiology techniques (i.e. gram staining, streak plating, culture maintenance and aseptic techniques) Knowledge of USP chapters related to microbiology is a plus Experience Required A minimum of 2‑4 years of professional experience in a pharmaceutical microbiology environment, or an equivalent combination of training and experience Skills/Abilities Proficiency in reading, writing and speaking English Read and comprehend Company policies and procedures, including safety rules and regulations Ability to multi-task and have good time management skills Good communication and customer service skills Working Conditions Incumbents in this class are subject to extended periods of sitting, standing, walking, lifting materials weighing up to 50 pounds, vision to monitor and moderate to loud noise levels Incumbents may be exposed to or work with toxic materials, toxic gases, electrical hazards, dangerous tools and equipment Work is performed in laboratory environment. Incumbents must be able to use personal protective equipment (e.g. respirators, gloves, etc) Applicants must be legally authorized to work in the United States without the need for current or future employer-sponsored visa sponsorship. Salary Range $60,000 - $68,000 annually, plus bonus Benefits Medical, behavioral & prescription drug coverage Health Savings Account (HSA) Dental Vision 401(k) savings plan with company match and profit sharing Basic and supplemental Life and AD&D insurance Flexible Spending Accounts (FSAs) Short & long-term disability Employee Assistance Program (EAP) Health Advocacy Program We also offer many voluntary benefits such as legal services, critical illness, hospital indemnity, accident coverage, ID theft and fraud protection, pet insurance and employee discounts. We are committed to helping our associates maintain a healthy and sustainable work/life balance and provide paid time off programs including sick & safe leave, vacation, company & floating holidays, paid parental leave, and depending on the position we also offer summer hours and flex place/flex time options. #J-18808-Ljbffr PDI