Pharmaceutical Microbiology Specialist - cGMP Focus

BioSpace

Petersburg (VA)

On-site

USD 75,000 - 110,000

Full time

10 days ago

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Job summary

Civica's Petersburg, Virginia site seeks a Microbiologist to support the microbiology laboratory for sterile injectable manufacturing, ensuring FDA-compliant quality systems and cGMP practices.

You will perform and review procedures, participate in environmental monitoring, qualify equipment, and help train staff while advancing a culture of quality and continuous improvement. Travel may be required.

Qualifications

  • Bachelor’s degree in a scientific discipline with at least 4 years in quality/cGMP in the pharmaceutical industry.
  • Strong project management, organizational, and execution skills.
  • Microbiology testing and environmental monitoring experience.
  • Participation in activities to support regulatory agency inspections is required.
  • Excellent interpersonal and written communication skills, and experience with various software/electronic applications, are 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.

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, endotoxin, microbial ID, and growth promotion studies.
  • Conduct and maintain qualifications of laboratory equipment and ongoing maintenance/calibration.
  • Establish and coordinate test sampling plans.
  • Perform microbiological testing and sample collection to support environmental monitoring and utilities systems.
  • Participate in verification of microbiological methods and method transfers.
  • Participate in development of training programs for microbiologists.
  • Lead or participate in investigations related to laboratory operations and non-conforming results.
  • Identify, track, and facilitate resolution of technical issues.
  • Conduct quality risk assessments related to microbiology and environmental monitoring.
  • Author/review SOPs, protocols, reports, test methods, and product specs as applicable.
  • Promote a quality mindset and quality excellence across activities.
  • Travel may be required.

Skills

Project management
Communication
Autonomy
Team collaboration

Education

Bachelor’s degree in science

Tools

LIMS
Electronic lab notebook
GxP software

Job description

Civica's Petersburg, Virginia site seeks a Microbiologist to support the microbiology laboratory for sterile injectable manufacturing, ensuring FDA-compliant quality systems and cGMP practices.

You will perform and review procedures, participate in environmental monitoring, qualify equipment, and help train staff while advancing a culture of quality and continuous improvement. Travel may be required.

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