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Agilent Technologies Life Sciences Chemical Analysis business is looking to add an Advanced Quality Control Microbiologist to their high-performance quality team working at the state-of-the-art, contract API manufacturing facility that specializes in Nucleic Acid Chemistries located in Boulder, Colorado.
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.
This position coordinates and conducts routine and non-routine microbiological analysis to support and refine the cleaning validation program. Responsibilities also include analysis of water monitoring, raw materials, in process, active pharmaceutical ingredients (APIs), stability samples and other requested testing according to Standard Operating Procedures, current Good Manufacturing Practices (cGMPs) and other regulatory requirements as needed.
The Intermediate Microbiologist will also work on complex problems to drive improvement in the microbiology/cleaning validation program, which requires sampling process water and executing Microbiology analysis. Future duties for this role will include raw materials and in process testing.
ESSENTIAL DUTIES AND RESPONSIBILITIES:
Exercises judgment within broadly defined practices and policies in selecting methods, techniques and evaluation criteria for obtaining results.
Outstanding communication skills, both written and oral, and will be expected to communicate directly with peers and area managers.
Conducts analysis associated with clinical and non-clinical laboratory studies under current Good Manufacturing Practices (GMP) regulations and guidance per Food and Drug Administration (FDA) and Organization for Economic Co-Operations and Development (OECD).
Coordinates and performs microbiological analysis on cleaning validation samples, raw materials, in-process materials, APIs (developmental and commercial) and other requested testing as per written procedures.
Reviews data for compliance to specifications, and reports and troubleshoots abnormalities.
Troubleshoots, investigates, and resolves microbiological failures and drives solutions to improve the microbiological program through effective corrective and preventive actions.
Ensures equipment is performing well and coordinates preventative maintenance.
Ensures good documentation practices are followed.
* Typically 2+ years of relevant experience for entry to this level
* A Bachelor's degree (B.S.) or equivalent in Microbiology or related life sciences field with 2+ years related experience and/or training; or equivalent combination of education and experience
* Knowledge of cGMP guidelines as well as international regulations (i.e., International Committee on Harmonization (ICH) Q7) pertaining to the microbiology and cleaning validation programs in support production of APIs and drug products
* Knowledge of analytical equipment and instrumentation utilized for the testing of microbiological samples
* Knowledge of FDA regulations and guidelines
* Must be able to use judgment and discretion to drive work assignments, and escalate to management appropriately.
* Personal leadership skills and works well with a team.
* Works cross functionally to complete projects and testing
* Knowledge of and skills in using computer software and hardware applications, including Microsoft Word and Excel
Agilent Technologies, Inc. is an Equal Employment Opportunity and Affirmative Action employer. We value diversity 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.
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