The QC Microbiologist I - is an entry-level role in the Microbiology Quality Control, responsible for performing Microbiological laboratory testing associated with Environmental Monitoring (EM), Purified Water (PW), and product specific Microbiological samples.
Additionally, Microbiologist I, will be trained to perform Environmental Monitoring (EM) and Purified Water (PW) sampling in support of cGMP manufacturing activities associated with transdermal manufacturing.
The Microbiologist is expected to follow all policies and procedures which include but are not limited to; Standard Operation Procedures (SOPs), Work Instructions (WI), current Good Manufacturing Practices (cGMPs), and current Good Laboratory Practices (cGLPs).
Perform Microbial Limit Testing for finished products and raw materials to assess potential microbiological contaminants.
Creates and maintains laboratory record documentation in compliance with regulatory requirements.
Actively participates in investigation of laboratory results, when required.
Prepares volumetric test solutions following USP or in-house methods for wet chemical tests, standardizes such solutions as required, standardizes API for use as in-house reference standard as assigned.
Qualifications
Competencies:
Education / Experience:
Bachelor’s Degree (BA/BS) in Microbiology, Biology, or related Life Sciences – Required.
Minimum of one year of related laboratory experience, academic or otherwise – Required.
Must be able to read and understand analytical procedures – Required.
Must be able to effectively communicate results, problems, or issues, in English verbally as well as in writing – Required.
Must be computer literate.
Knowledge of aseptic techniques.
Experience in activities pertaining to aseptic manufacturing and knowledge of how to maintain an aseptic environment.
Ability to multi-task, work under pressure with time constraints.
Must be precise and consistent in day-to-day analysis, easily trainable, and ready to learn.
Must be able to work in a team environment and be flexible to easily adapt to changes in assignments.
Must follow safe practices as identified in appropriate SDS while working with chemicals and must follow applicable state and federal regulations.
Must be able to follow compendial (USP/EP/BP/JP) procedures for microbiological tests.
Must understand and apply cGMP requirements applicable to quality control laboratory.
Judgment / Decision Making:
Duties are performed within framework of departmental or functional guidelines, requiring interpretation and original thinking.
Work Environment:
A laboratory environment with exposure to microorganisms, safety cabinets, heat, and electrical current.
Physical Demands:
Visual acuity and manual dexterity required to operate computer, analytical instrumentation, sample preparation. Majority of time spent standing. Often required to lift objects weighing up to 20 pounds.
