Microbiology Lab Specialist

2 weeks ago

San Dimas, California, United States Fladger Assoc. Inc. Full time
Job Overview

Fladger Assoc. Inc. is seeking a highly skilled Microbiology Lab Analyst to join our team in the pharmaceutical industry. As a key member of our quality control department, you will be responsible for ensuring the highest standards of product quality and safety.

Key Responsibilities
  • Perform final product release testing, including endotoxin and sterility testing, to ensure compliance with regulatory requirements.
  • Conduct raw material release testing, including microbial limits and endotoxin, to guarantee the quality of incoming materials.
  • Test, analyze, and submit results to ensure commercial manufacturing activities are not impacted.
  • Coordinate routine monitoring and validation activities to maintain a high level of quality control.
  • Order supplies and assign expiration dates to incoming materials, track requisitions, and reconcile against incoming materials and invoices.
  • Perform microbiological testing of raw materials, in-process products, final products, validation-related samples, and critical utility samples.
  • Conduct bioburden testing of water and product to ensure a safe and healthy environment.
  • Perform growth promotion testing for incoming media to ensure its quality and effectiveness.
  • Develop and maintain a working knowledge of Good Manufacturing Practices (GMPs), pharmacopoeial, and regulatory requirements for testing and validation in the pharmaceutical industry.
  • Stay up-to-date with changes to pharmacopoeial requirements and implement new methods as necessary.
  • Understand and apply USP/BP/JP and EP pharmacopoeias and the change process.
  • Communicate effectively with colleagues and management to ensure seamless execution of quality control activities.
  • Proficiency in Microsoft Office applications is required.
Requirements
  • 1+ years of relevant experience and a BS Degree in Microbiology or equivalent.
  • Prior experience in the pharmaceutical industry is preferred.
  • Medical requirements include blood work, urinalysis, physical non-DOT history, vision test, and other standard medical evaluations.
  • Shift: 11AM- 8PM, with flexibility required at times and occasional weekend work.

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