Performs routine and non-routine quality control testing of in-process samples, raw materials, and commercial or developmental materials under cGMP, FDA, and international requirements. Reviews data, investigates abnormalities, ensures equipment performance, maintains documentation, and escalates issues. Requires laboratory experience with analytical instrumentation, including HPLC and HPLC-MS, plus knowledge of regulatory guidelines and good laboratory practices.
Job DescriptionQualifications
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 in-process 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 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 in-process samples (developmental and commercial), raw materials, 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
- A Bachelor's degree (B.S.) in Chemistry or a related life sciences field
- 2-5 years of relevant experience within the Industry
- Exposure to and knowledge of FDA regulations and guidelines
- Knowledge of cGMP guidelines or international regulations (i.e., International Committee on Harmonization (ICH) Q7)
- Knowledge of analytical equipment and instrumentation utilized for the testing of in-process samples. May require cross-training to support raw material and microbiological testing.
- May require handling of highly potent API material.
- Proficient with Microsoft Word and Excel
- Familiarity with the following laboratory disciplines is highly desired:
- Chemstation
-UV analysis
-HPLC
-HPLC-MS
Additional Details
This job has a full time weekly schedule. Applications for this job will be accepted until at least October 26, 2026 or until the job is no longer posted.The full-time equivalent pay range for this position is $34.00 - $53.13/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 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 www.agilent.com/en/accessibility.Travel Required: NoShift: DayDuration: No End DateJob Function: Quality/RegulatorySimilar Jobs
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