Job Description

Job Description

Job Description

The world's most revolutionary biopharma companies are partnering with Agilent Technologies to advance the next frontier of medicine. Agilent continues to invest in capacity and expansion of its Colorado operations. Join our team of professionals dedicated to the development and commercialization of nucleic acid therapeutics for life changing, lifesaving medicines.

We are seeking a detail-oriented and experienced Quality Control Microbiology Analyst to join our growing Quality team. In this role, you will support product release, stability testing, environmental monitoring, and cleaning verification activities under cGMP and GLP conditions. You'll play a key part in ensuring the quality and safety of pharmaceutical products while maintaining strict compliance with FDA, ICH, and international regulatory standards.

Key Responsibilities

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• Conduct routine and non-routine microbiological and analytical testing in accordance with Standard Operating Procedures (SOPs) and current Good Manufacturing Practices (cGMPs).
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• Perform testing for Active Pharmaceutical Ingredients (APIs), final drug products, and in-process samples.
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• Review and interpret data to ensure compliance with product specifications; troubleshoot and escalate abnormalities as necessary.
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• Conduct environmental monitoring, cleaning verification, and stability testing.
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• Ensure laboratory equipment is functioning properly and initiate corrective actions as needed.
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• Maintain thorough and accurate documentation following Good Documentation Practices (GDP).
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• Communicate effectively with project managers and internal stakeholders regarding test results, timelines, and any issues.
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• Participate in the continuous improvement of laboratory processes, procedures, and quality systems.
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• Collaborate cross-functionally to meet project timelines and operational goals.
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Shift Schedule: Mondays to Fridays on an Evening Shift

Qualifications

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• Bachelor's degree in Microbiology, Life Sciences, or related field.
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• Minimum of 2 years of experience in a Quality Control laboratory setting, preferably in the pharmaceutical or biotechnology industry.
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• Knowledge of cGMP guidelines as well as international regulations (i.e., International Committee on Harmonization (ICH) Q7) pertaining to Quality Control programs that support production of APIs, stability and drug product release
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• Knowledge of analytical equipment and instrumentation, experience working in a GMP environment is preferred
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• Knowledge of FDA regulations and guidelines
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• Skills in coordinating and handling day to day tasks and working in collaboration to accomplish deadlines and objectives
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• Personal leadership skills and fosters working in a team environment
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• Works cross functionally to complete projects and testing.
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• Knowledge of and skills in using computer software and hardware applications, including Microsoft Word and Excel
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• Familiarity with a wide range of microbiological and analytical techniques below is preferred:
  
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  • Bacterial Endotoxin Testing (LAL Analysis)
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  • Bioburden Testing (Membrane Filtration)
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  • Total Organic Carbon (TOC) Testing
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  • Compressed Gas Monitoring
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  • Environmental Monitoring
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  • UV Analysis
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  • USP <61> testing
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Additional Details

This job has a full time weekly schedule. Applications for this job will be accepted until at least September 12, 2025 or until the job is no longer posted.

The full-time equivalent pay range for this position is $31.92 - $49.88/hr plus eligibility for bonus, stock and benefits. Our pay ranges are determined by role, level, and location. Within the range, individual pay is determined by work location and additional factors, including job-related skills, experience, and relevant education or training. During the hiring process, a recruiter can share more about the specific pay range for a preferred location. Pay and benefit information by country are available at:

Agilent Technologies, Inc. is an Equal Employment Opportunity and merit-based employer that values individuals of all backgrounds at all levels. All individuals, regardless of personal characteristics, are encouraged to apply. All qualified applicants will receive consideration for employment without regard to sex, pregnancy, race, religion or religious creed, color, gender, gender identity, gender expression, national origin, ancestry, physical or mental disability, medical condition, genetic information, marital status, registered domestic partner status, age, sexual orientation, military or veteran status, protected veteran status, or any other basis protected by federal, state, local law, ordinance, or regulation and will not be discriminated against on these bases. Agilent Technologies, Inc., is committed to creating and maintaining an inclusive in the workplace where everyone is welcome, and strives to support candidates with disabilities. If you have a disability and need assistance with any part of the application or interview process or have questions about workplace accessibility, please email [email protected] or contact +1-262-754-5030. For more information about equal employment opportunity protections, please visit

Travel Required:
Occasional

Shift:
Day

Duration:
No End Date

Job Function:
Quality/Regulatory

Job Tags

Full time, Local area, Shift work, Afternoon shift, Monday to Friday,

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