Performs professional, technical laboratory functions.

• 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.

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.