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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.
The Quality Control Analyst will:
Conduct routine and non-routine analysis and reviews of analytical data for stability, raw materials, in-process, microbiology/ cleaning validation program and other requested testing according to Standard Operating Procedures (SOP) and Analytical Methods in accordance with current Good Manufacturing Practices (cGMPs) and regulatory requirements
Complete projects with supervision and have a clear understanding of Good Laboratory Practices (GLPs), cGMPS, and other regulatory requirements
Effectively engages in continuous improvement of processes and procedures
Ability to exercise judgment and appropriately raises issues to QC management
Essential Duties and Responsibilities:
Outstanding interpersonal skills, both written and oral, and will be encouraged to collaborate with project managers and management
Conducts analysis associated with clinical and commercial under current Good Manufacturing Practices (GMP) regulations and guidance per Food and Drug Administration (FDA) and Organization for Economic Co-Operations and Development (OECD) as well as International regulations
Performs analysis on stability, raw materials, in-process materials, APIs (developmental and commercial), final product and other requested testing as per written procedures
Reviews data for compliance to specifications, and reports and troubleshoots abnormalities
Ensures equipment is performing well and communicates and takes appropriate action as necessary
Required to follow good documentation practices
Works cross-functionally to complete projects and testing
First shift hours: Mon-Friday, 8 am - 4 pm
QualificationsBachelor's or Master's Degree or equivalent
Post-graduate, certification, and/or license may be required
Generally, requires minimal to no prior relevant work experience
Demonstrated knowledge of analytical equipment and instrumentation and working in a GMP environment is helpful
Knowledge of FDA regulations and guidelines is helpful
Proven skills in coordinating and leading day to day tasks and working in collaboration to accomplish deadlines and objectives
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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.Agilent Technologies, Inc., is committed to diversity in the workplace 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 job_posting@agilent.com or contact +1-262-754-5030.For more information about equal employment opportunity protections, please visit www.agilent.com/en/accessibility.Pay Range$52,056.00-$81,338.00The salary range for this position may differ based on your actual work location.
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NoTravel RequiredNoScheduleSchedule:Full timeShiftDayDurationNo End DateJob FunctionQuality/Regulatory