Microbiologist - Quality Assurance Specialist

4 weeks ago

Washington, Washington, D.C., United States Civica Rx Full time
About Civica Rx

Civica Rx is a 501(c)(4) social welfare organization dedicated to reducing chronic generic drug shortages and related high prices in the United States. Our mission is to ensure the consistent availability of affordable medications, particularly for those who need them most.

We are a collaborative effort between health systems and philanthropies, with a team of experienced healthcare and pharmaceutical industry leaders. Our goal is to make a meaningful impact on the lives of patients and communities across the country.

Job Description

We are seeking a highly skilled Microbiologist to join our team at our Petersburg, Virginia site. As a key member of our quality assurance team, you will play a critical role in ensuring the microbiology laboratory and testing comply with applicable regulatory standards and expectations for the development and reliable supply of quality medicines.

Key Responsibilities:
  • Support the establishment and maintenance of the microbiological testing laboratory to ensure compliance with cGMPs and industry standards for best practices.
  • Perform microbiological testing methods consistent with USP testing requirements, including bioburden, bacterial endotoxin, identification of microbial isolates and objectionable organisms, viable/non-viable particulate monitoring, and growth promotion studies.
  • Conduct and maintain qualifications of laboratory equipment as well as ongoing maintenance and calibration.
  • Establish and coordinate test sampling plans to ensure the reliability and accuracy of our testing results.
  • Participate in verification of microbiological methods and method transfers to ensure seamless integration with our quality control processes.
  • Lead and/or participate in investigations related to laboratory operations and non-conforming results to identify and resolve technical issues.
  • Identify, track, and facilitate resolution of technical issues in a timely and effective manner.
  • Conduct quality risk assessments related to microbiology and environmental monitoring to ensure the highest level of quality and compliance.
  • Author and/or review SOPs, protocols, reports, test method and product specification documents as applicable to ensure accuracy and compliance.
  • Promote a quality mindset and quality excellence approach to all activities to ensure the highest level of quality and compliance.
Requirements:
  • Bachelor's degree in a scientific discipline (microbiology degree preferred) with a minimum of 4 years Quality/cGMP experience in the pharmaceutical industry.
  • Strong project management, organization, and execution skills to ensure the successful implementation of quality control processes.
  • Microbiology testing and environmental monitoring experience to ensure the reliability and accuracy of our testing results.
  • Excellent interpersonal and written communication skills to effectively collaborate with cross-functional teams and communicate complex technical information.
  • Self-motivated, flexible, and able to work in a small, fast-paced, dynamic environment to ensure the highest level of quality and compliance.
  • Ability to work autonomously and within established guidelines, procedures, and practices to ensure the highest level of quality and compliance.
Preferred Qualifications:
  • Experience in sterile injectable manufacturing, aseptic processing, and facility qualification to ensure the highest level of quality and compliance.
  • Experience with the following microbiological testing and procedures: Sterility testing and method suitability testing per USP , Acceptance testing and use of biological indicators.

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