Microbiologist 2nd Shift Specialist

3 days ago

Petersburg, 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. Founded in 2018 by health systems and philanthropies, Civica Rx aims to ensure the consistent availability of affordable medications.

With over 55 health systems and 1,500 hospitals on board, Civica Rx has supplied essential medicines to the U.S. Department of Veteran's Affairs, the U.S. Department of Defense, and the U.S. Strategic National Stockpile. The organization's mission extends beyond the hospital setting, focusing on lowering medication costs at the pharmacy counter.

Job Description

The Microbiologist 2nd Shift will join Civica Rx's Petersburg, Virginia site, contributing their expertise to the development and reliable supply of quality medicines. This role is crucial in ensuring the microbiology laboratory and testing comply with regulatory standards and expectations.

Responsibilities
  • Support the establishment and maintenance of the microbiological testing laboratory to ensure compliance with cGMPs and industry standards.
  • Lead 2nd shift microbiological activities, performing microbiological testing methods consistent with USP testing requirements.
  • Conduct and maintain qualifications of laboratory equipment, establish and coordinate test sampling plans, and participate in verification of microbiological methods and method transfers.
  • Identify, track, and facilitate resolution of technical issues, conduct quality risk assessments related to microbiology and environmental monitoring, and promote a quality mindset and quality excellence approach to all activities.
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, with experience in sterile injectable manufacturing, aseptic processing, and facility qualification.
  • Excellent interpersonal and written communication skills, with experience using various software/electronic applications.
Preferred Qualifications
  • 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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