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