Associate Microbiologist – 3rd Shift (401) jobs in United States
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Civica Rx · 2 weeks ago

Associate Microbiologist – 3rd Shift (401)

Civica Rx is a nonprofit organization dedicated to preventing and mitigating drug shortages in the U.S. healthcare system. The Associate Microbiologist will support the microbiology laboratory at the Petersburg site, ensuring compliance with regulatory standards and performing various microbiological testing methods essential for the manufacture of sterile injectable medications.

Pharmaceutical
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H1B Sponsor Likelynote

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 but not limited to the following microbiological testing and procedures: bioburden, bacterial endotoxin, identification of microbial isolates and objectional 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
Perform microbiological testing and sample collection to support environmental monitoring (EM) and utilities systems
Participate in verification of microbiological methods and method transfers
Participate in the development of training programs for microbiologist
Lead and/or participate in investigations related to laboratory operations and non-conforming results
Identify, track, and facilitate resolution of technical issues
Proactively identify and work collaboratively to resolve problems taking risk-based and compliant approaches to solutions
Author and/or review SOPs, protocols, reports, test methods, and product specification documents as applicable
Promote a quality mindset and quality excellence approach to all activities
Travel (up to 10%) may be required

Qualification

Microbiology testingCGMP experienceEnvironmental monitoringSterile injectable manufacturingAseptic processingQuality mindsetProject managementInterpersonal skillsWritten communicationSelf-motivated

Required

Bachelor's degree in a scientific discipline (microbiology degree preferred) with a minimum of 2+ years of Quality/cGMP experience in the pharmaceutical industry
Strong project management, organization, and execution skills
Microbiology testing and environmental monitoring experience
Participation in activities to support regulatory agency inspections required
Excellent interpersonal and written communication skills and experience using various software/electronic applications required
Self-motivated, flexible, and able to work in a small, fast-paced, dynamic, environment
Ability to work autonomously and within established guidelines, procedures, and practices
Committed to delivering high-quality results, working with others to overcome challenges, and focusing on what matters
Continuously looking for opportunities to learn, build skills, and share knowledge with others

Preferred

Experience in sterile injectable manufacturing, aseptic processing, and facility qualification
Environmental monitoring per Annex 1 requirements
Experience with the following microbiological testing and procedures: Sterility testing and method suitability testing per USP - Acceptance testing and use of biological indicators

Company

Civica Rx

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Civica Rx was created in late 2018 to secure the supply of important medicines hospitals use every day.

H1B Sponsorship

Civica Rx has a track record of offering H1B sponsorships. Please note that this does not guarantee sponsorship for this specific role. Below presents additional info for your reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (7)
2024 (2)
2022 (1)
2021 (2)

Funding

Current Stage
Growth Stage
Total Funding
$3M
2025-08-07Grant· $3M

Leadership Team

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Ned McCoy
CEO
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Dave Sehgal
Chief Manufacturing and Supply Chain Officer
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Company data provided by crunchbase