Position Summary
The Microbiologist I performs routine microbiological testing to support product quality and safety, ensuring compliance with USP, cGMP and ISO 17025 standard, accurate documentation, data integrity and basic lab support in a regulated environment.
What You Will Do
• Perform and result routine microbiological testing on samples in a timely manner, independently with some supervision, to meet assigned testing deadlines.
• Ensure accuracy and validity of results in accordance with SOPs and regulatory standards.
• Interpret test results to determine pass/fail status and escalate unexpected findings to senior staff.
• Record, report, and investigate unexpected test results with some supervision.
• Prepare samples, reagents, and media for daily testing activities.
• Support sample receipt and chain of custody documentation.
• Regularly handle BSL-1 and BSL-2 regulated microorganisms following proper safety and workflow practices.
• Maintain current and accurate documentation in compliance with GMP and GDP standards.
• Clean, organize, and maintain laboratory workspaces and equipment to ensure readiness and compliance.
• Perform standard operational maintenance and minimal troubleshooting of assigned equipment and systems to confirm equipment is operational prior to use. Notify supervisor and engineering promptly of calibration failures and repair needs.
• Ensure proper disposal of biohazard waste in accordance with SOPs.
• Comply with company policies and all applicable SOPs; adhere to ISO 17025, BSLT-2 cGMPs, cGLPs, A2LA requirements, and Quality Control Guidelines.
• Participate in training sessions and cross-technology educational programs to expand technical knowledge and proficiency in advanced microbiological techniques.
• Stay abreast of current technology and instruments, with emphasis on microorganisms, equipment troubleshooting, and microbiology/taxonomy issues.
• Provide technical assistance and back-up support across laboratory workstations as required.
• Overtime and occasional weekend hours may be required.
• Prepare and assist with special projects, as needed.
• Manufacturing and quality control testing for in-house media production.
• Aseptic production of BSL-1 and BSL-2 microbial stocks.
Who You Are
Who We Are
Serving customers since 2004, Eagle offers the highest quality in preparation testing for sterility, bacterial endotoxins, microbial detection, beyond-use dating (BUD) determination and active ingredient potency. State-of-the-art equipment, combined with the experience and knowledge of our team, makes Eagle the best choice for all testing needs. The Eagle team is committed not only to performing the best quality control testing, but also working relentlessly with our customers on solutions if tests receive unexpected results. Learn more at www.eagleanalytical.com.
Pcca Usa, Pcca Canada
PCCA is the leading supplier of pharmacy chemicals, pharmacy equipment, and pharmacy compounding education that empowers compounding pharmacies to make personalized medicine for unique patient health challenges.
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