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Hybrid QC Microbiologist na Noven Pharmaceuticals

Noven Pharmaceuticals · Miami, Estados Unidos Da América · Hybrid

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Overview:

Performs professional, technical laboratory functions.

Responsibilities:
  • 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.

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