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 review to support release, stability testing per Standard Operating Procedures (SOP) and Analytical Methods in accordance with current Good Manufacturing Practices (cGMPs) and regulatory requirements. Has a clear understanding of Good Laboratory Practices (GLPs), cGMPS, and other regulatory requirements.
Effectively engages in continuous improvement of processes and procedures. Proven ability to exercise judgment and appropriately escalate issues to QC management.
Essential duties and responsibilities:
Outstanding communication skills, both written and oral, and will be expected to communicate directly 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 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.Exercises judgment within broadly defined practices and policies in selecting methods, techniques and evaluation criteria for obtaining results.SHIFT: DAY SHIFT Monday - Friday: 8 am - 4:30 pm, Monday -Friday
QualificationsBachelor’s Degree or equivalent experience in Analytical Chemistry or related life sciences field 0-2 years relevant experience lab experienceExperience with stability testing, HPLC, UV Vis, pH testing, and other analytical testing.Knowledge of cGMP guidelines as well as international regulations (i.e., International Committee on Harmonization (ICH) Q7) pertaining to Quality Control programs that support the production of APIs, stability, and drug product release is helpfulDemonstrated knowledge of analytical equipment and instrumentation, HPLC experience working in a GMP environment is preferredAbility to perform day to day tasks and working in collaboration to accomplish deadlines and objectives Knowledge of and skills in using computer software and hardware applications, including Microsoft Word and ExcelAdditional Details
This job has a full time weekly schedule. Applications for this job will be accepted until at least March 10, 2025 or until the job is no longer posted.The full-time equivalent pay range for this position is $26.08 - $40.75/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: https://careers.agilent.com/locationsAgilent 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.Travel Required: NoShift: DayDuration: No End DateJob Function: Quality/Regulatory