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Microbiological Quality Assurance Specialist

2 months ago

Fremont, California, United States Compunnel Inc. Full time
Position Overview

As a Microbiological Quality Assurance Specialist, you will play a crucial role in ensuring the integrity and quality of our products through rigorous testing and adherence to industry standards.

Key Responsibilities
  • Testing Coordination: Manage and execute both routine and specialized testing in Quality Control Microbiology for various drug substances and products within a diverse manufacturing environment.
  • Independent Operations: Conduct essential procedures such as bioburden assessments, endotoxin evaluations, and growth promotion tests with minimal supervision, following comprehensive training.
  • Support Functions: Assist in maintaining laboratory operations by replenishing supplies, updating standard operating procedure (SOP) documentation, disposing of outdated reagents, and identifying and reporting any process or equipment irregularities.
  • Quality Documentation: Ensure the delivery of precise analytical results within established timelines, documenting all activities in compliance with current Good Manufacturing Practices (cGMP) and current Good Documentation Practices (cGDP).
  • Regulatory Compliance: Follow all relevant regulations and cGMP guidelines, promptly reporting any abnormalities or deviations encountered during testing.
  • Safety Standards: Uphold safety protocols by recognizing unsafe practices and conditions, escalating issues as necessary, and maintaining work areas according to established cleanliness standards (5S methodology).
  • Training and Development: Keep personal training up to date and provide guidance to fellow technicians and associates on operational procedures after achieving trainer qualifications.
Required Skills
  • 3-5 years of experience in a regulated environment, with a strong preference for Good Manufacturing Practice (GMP) experience.
  • Excellent interpersonal and communication skills, both written and verbal, with a strong emphasis on customer service and collaboration across various departments.
  • Ability to work autonomously as well as collaboratively within a team to achieve departmental and organizational objectives.
  • Meticulous attention to detail, with a strong focus on the execution of tasks.
Educational Qualifications
  • A Bachelor’s degree in Biology or a related Life Sciences field is required.