Quality Control Microbiology Analyst
Quality Control Microbiology Analyst
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Job Description
Job Description
The worlds 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 this role you will support product release stability testing environmental monitoring and cleaning verification activities under cGMP and GLP conditions. Youll 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
Conduct routine and non-routine microbiological and analytical testing in accordance with Standard Operating Procedures (SOPs) and current Good Manufacturing Practices (cGMPs).
Perform testing for Active Pharmaceutical Ingredients (APIs) final drug products and in-process samples.
Review and interpret data to ensure compliance with product specifications; troubleshoot and escalate abnormalities as necessary.
Conduct environmental monitoring cleaning verification and stability testing.
Ensure laboratory equipment is functioning properly and initiate corrective actions as needed.
Maintain thorough and accurate documentation following Good Documentation Practices (GDP).
Communicate effectively with project managers and internal stakeholders regarding test results timelines and any issues.
Participate in the continuous improvement of laboratory processes procedures and quality systems.
Collaborate cross-functionally to meet project timelines and operational goals.
Shift Schedule: Mondays to Fridays on an Evening Shift
Qualifications
Bachelors degree in Microbiology Life Sciences or related field.
Minimum of 2 years of experience in a Quality Control laboratory setting preferably in the pharmaceutical or biotechnology industry.
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
Knowledge of analytical equipment and instrumentation experience working in a GMP environment is preferred
Knowledge of FDA regulations and guidelines
Skills in coordinating and handling day to day tasks and working in collaboration to accomplish deadlines and objectives
Personal leadership skills and fosters working in a team environment
Works cross functionally to complete projects and testing.
Knowledge of and skills in using computer software and hardware applications including Microsoft Word and Excel
Familiarity with a wide range of microbiological and analytical techniques below is preferred:
Bacterial Endotoxin Testing (LAL Analysis)
Bioburden Testing (Membrane Filtration)
Total Organic Carbon (TOC) Testing
Compressed Gas Monitoring
Environmental Monitoring
UV Analysis
USP <61> testing
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: 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 or contact 1-. For more information about equal employment opportunity protections please visit Required: OccasionalShift:
DayDuration:
No End DateJob Function:
Quality/RegulatoryRequired Experience:
IC
Employment Type
Full-Time
