Jobs · Analyst · Texas

Microbiologist II - Non-Sterile

BioSpace · Houston, TX · 1 mo ago
AnalystFull-time

About the role

Eagle offers the highest quality in preparation testing for sterility, bacterial endotoxins, microbial detection, beyond-use dating (BUD) determination, and active ingredient potency. Our team is committed to performing top-tier quality control testing and working relentlessly with customers to find solutions for unexpected test results.

Schedule

  • 1st shift: Tuesday – Saturday (days off: Sunday and Monday), 7:00 AM – 4:00 PM
  • 2nd shift: Monday – Friday (days off: Saturday and Sunday), 11:00 AM – 8:00 PM

Responsibilities

  • Perform and result routine testing on samples in a timely manner independently, with some supervision, to meet assigned testing deadlines
  • Interpret results to determine pass or fail
  • Manufacturing and quality control testing for in-house media production
  • Perform complex testing with minimal supervision
  • Aseptic production of BSL-1 and BSL-2 microbial stocks
  • Record, report, and investigate unexpected test results with some supervision
  • Handle and maintain BSL-2 regulated microorganisms
  • Comply with company policies, SOPs, ISO 17025, BSLT-2 cGMPs, cGLPs, A2LA requirements, and Quality Control Guidelines
  • Perform standard operational maintenance and minimal troubleshooting of assigned equipment and systems to confirm operational readiness; notify supervisor and engineering of calibration failures or repair needs
  • Participate in cross-technology educational programs within the laboratory to learn all laboratory functions
  • Stay abreast of current technology and instruments, with emphasis on microorganisms, equipment and system troubleshooting, and microbiology/taxonomy issues
  • Provide technical assistance and back-up support in all laboratory workstations as required
  • Maintain current and accurate documentation
  • Assist with laboratory compliance audits and laboratory safety audits
  • Maintain a clean, orderly, and safe laboratory work area

Requirements

  • Bachelor’s degree in microbiology or related science field, including at least 12 semester hours of hands-on laboratory courses in microbiology and/or chemistry
  • MS or minimum 3 years of pharmaceutical/biochemical QC laboratory experience in a microbiology setting
  • Demonstrated relevant experience in a microbiology laboratory (Q.C., pharmaceutical, biotech, or clinical lab experience preferred), performing one or more of the following functions:
    • Microbial enumeration testing
    • Growth promotion testing
    • Streak for isolation
    • Testing with microorganisms
    • Environmental monitoring
    • Method suitability
    • Microbial identification
    • Gram staining
    • Pipetting small volumes
    • SOP/documentation revisions
  • Excellent analytical, decision-making, and interpersonal skills
  • Excellent verbal and written communication skills
  • Strong working knowledge and understanding of microbiology principles and methods, with the ability to communicate this information to others
  • Ability to multitask within a single task and across multiple tasks when applicable
  • Ability to solve routine and non-routine laboratory issues/problems
  • Physical dexterity to perform testing accurately and precisely
  • Ability to read, understand, and comply with company policies and SOPs, including safety rules and regulations
  • Ability to work independently with minimal supervision
  • Intermediate-level computer skills in Microsoft Office (Word, Excel, Outlook, PowerPoint)

Skills

  • Customer Service (Advanced)
  • Communication (Novice)
  • Active Listening (Novice)
  • Team Player: Works well as a member of a group
  • Detail Oriented: Capable of carrying out tasks with precision
  • Self-Starter: Inspired to perform without outside help
  • Ability to Make an Impact: Inspired to contribute to project or organizational success
  • Flexibility: Inspired to perform well with the ability to set your own schedule and goals

Preferred Qualifications

  • Experience in virology and fibology
  • SOP creation and implementation
  • 2+ years of GMP and/or cGMP experience

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