Associate Microbiologist — GMP Lab & Quality Impact

BioSpace; Petersburg (VA); On-site; USD 65,000 - 95,000; Full time

Job summary

Civica, Inc. in Petersburg, VA seeks an Associate Microbiologist to support microbiology testing and environmental monitoring, ensuring regulatory compliance.

The role contributes to the new fill-finish facility producing generic sterile injectables and oversees procedures and records for FDA-aligned operations. The candidate will work in a fast-paced environment, maintain lab equipment, support investigations, and collaborate on risk-based solutions to ensure quality medicines are reliably

Qualifications

• Bachelor’s degree in a scientific discipline (microbiology preferred) with a minimum of 2 years QA/cGMP experience.
• Strong organizational and execution skills.
• Microbiology testing and environmental monitoring experience.
• Participation in activities to support regulatory agency inspections is required.

Responsibilities

• Perform microbiological testing methods consistent with USP testing requirements.
• Maintains laboratory equipment as well as ongoing maintenance and calibration.
• Executes 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 investigations related to laboratory operations and non-conforming results.
• Identify, track, and facilitate resolution of technical issues.
• Participate in risk assessments related to microbiology and environmental monitoring.
• 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.

Skills

Organizational skills

Communication skills

Autonomous work

Regulatory experience

Education

Bachelor’s degree in a scientific discipline (microbiology preferred)

Job description

Civica, Inc. in Petersburg, VA seeks an Associate Microbiologist to support microbiology testing and environmental monitoring, ensuring regulatory compliance.

The role contributes to the new fill-finish facility producing generic sterile injectables and oversees procedures and records for FDA-aligned operations. The candidate will work in a fast-paced environment, maintain lab equipment, support investigations, and collaborate on risk-based solutions to ensure quality medicines are reliably