Microbiologist II

PDI•Town of Orangetown, NY

1d•$60,000 - $68,000•Onsite

About The Position

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.

Requirements

Bachelor’s degree in Biology, Microbiology , Chemistry or related science from an accredited college or university
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)
A minimum of 2-4 year of professional experience in a pharmaceutical microbiology environment, or an equivalent combination of training and experience.
Proficiency in reading, writing and speaking English
Be able to read and comprehend Company policies and procedures, including safety rules and regulations
Ability to multi-task and have good time management skills.
Must have good communication and customer service skills.

Nice To Haves

Knowledge of USP chapters related to microbiology is a plus

Responsibilities

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. Able to document results and report appropriately
Sampling and testing water, environmental air and surface. Able to 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 certifications 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
Ensures 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