Quality Control Microbiologist I

3 years

0 Lacs

Posted:2 weeks ago| Platform: Linkedin logo

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On-site

Job Type

Full Time

Job Description

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Job Overview

Under minimal direction from the manager, The Microbiologist I performs raw material testing, finished product testing, stability testing, water testing, media preparation, growth promotion of media, antibiotic microbial assay testing, microbial identification, method development testing, suitability testing, antimicrobial effectiveness testing, and other microbial testing as needed. Furthermore, auditing of microbial testing including, but not limited to, water testing, growth promotion of media, and environmental monitoring is executed as necessary. Work is completed with an overall quality and efficiency. Writes, updates, and evaluates new test methods and procedures. Attends team meetings and coordinates projects within the laboratory. This is a safety sensitive position.

Responsibilities

  • Routine Microbial Examination Testing (raw materials, finished products, stabilities).
  • Routine water testing, media preparation, growth promotion of media, environmental monitoring, and identification of unknown microorganisms.
  • Method development testing, suitability testing, antimicrobial effectiveness testing, antibiotic assay testing and other microbial testing as needed.
  • Auditing of testing (e.g. water, growth promotion, environmental monitoring).
  • Training of analysts / technicians.
  • Perform routine testing to support other groups.
  • Perform routine testing to support other groups.
  • Follows Environmental, Health and Safety policies and procedures. Performs other duties as assigned or as business needs require.
  • Able to work overtime, weekends when required.

Experience

  • B.S. with minimum three years related pharmaceutical microbiology experience.
  • Advanced degree in scientific field with two yrs. related experience.
  • Experience in training of other analysts in laboratory techniques preferred. Good understanding of laboratory safety practices and PPE
    • Expectation of zero safety observations
  • Good understanding of cGMP
    • Minimal to no laboratory errors are expected
  • Good understanding of good documentation practices
    • Minimal corrections/errors expected
  • Good understanding of compendial testing requirements
    • Additional understanding of international compendiums such as EP
  • Minimum 3 years of experience in Microbiology laboratory
    • Expected knowledge of autoclave usage, media preparation, aseptic technique, balance use, pH meter, environmental monitoring, and general plating practices.
    • Competency to perform bioassay. Able to QC prepared or purchased media.
    • Able to perform assigned task from start to finish independently without error. Including standard, sample, and reagent preparation through data processing and submission.

Qualifications

Education

  • B.S. in microbiology, biology or related life science.

Specialized/Technical Knowledge

  • Working knowledge of aseptic technique, microbial examination methods, antibiotic microbial assay, microbial identification and proficiency in many of these techniques.
  • Excellent knowledge of FDA, USP, ICH, cGMP, and cGLP requirements in a pharmaceutical quality control laboratory.
  • Excellent computer skills including MS Office and LIMS.

Functional Knowledge

  • Excellent organizational skills and attention to detail.
  • Excellent at multitasking, handling multiple projects at one time, and changing priorities based on business needs.
  • Self-driven and motivated.
  • Excellent problem solving skills.
  • Excellent interpersonal and communication skills.
  • Time management skills.

Physical Requirements

  • Lift/move up to 10 lbs. and occasionally 25 lbs.
  • Individual may be required to handle hazardous and non-hazardous materials.
  • Individual may be required to wear Personal Protective Equipment.
  • Not allergic to chemicals or biosubstances found in the laboratory or production facilities
Job Info
  • Job Identification 90441128
  • Job Category Quality Control
  • Posting Date 07/07/2025, 10:38 PM
  • Job Schedule Full time
  • Locations USA-650 Cathill Road, Sellersville, PA, 18960, US

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