Quality Control Analyst

Posted 3 Days Ago
Be an Early Applicant
Frederick, CO, USA
In-Office
34-53 Hourly
Mid level
Biotech
The Role
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.
Summary Generated by Built In
Job Description

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

Qualifications
  • 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/locations

Agilent 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/Regulatory

Skills Required

  • Bachelor’s degree in Chemistry or a related life sciences field
  • 2–5 years of relevant industry experience
  • Exposure to FDA regulations and guidelines
  • Knowledge of cGMP guidelines or international regulations such as ICH Q7
  • Knowledge of analytical equipment and instrumentation for in-process sample testing
  • Proficiency with Microsoft Word and Excel
  • Familiarity with ChemStation
  • Familiarity with UV analysis
  • Familiarity with HPLC
  • Familiarity with HPLC-MS

Agilent Technologies Compensation & Benefits Highlights

The following summarizes recurring compensation and benefits themes identified from responses generated by popular LLMs to common candidate questions about Agilent Technologies and has not been reviewed or approved by Agilent Technologies.

  • Retirement Support — The core U.S. package highlights a generous 401(k) match as a strength. Retirement programs are positioned as competitive within the company’s total rewards.
  • Equity Value & Accessibility — An Employee Stock Purchase Plan at a discount provides accessible equity and augments total compensation. Ownership opportunities are presented as a notable advantage alongside retirement benefits.
  • Leave & Time Off Breadth — Flexible Time Off, company holidays, a personal holiday, and paid volunteer time create a broad leave offering. Time off can accrue into multiple weeks in the first year, supporting flexibility.

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The Company
HQ: Santa Clara, CA
17,369 Employees
Year Founded: 1999

What We Do

Analytical scientists and clinical researchers worldwide rely on Agilent to help fulfill their most complex laboratory demands. Our instruments, software, services and consumables address the full range of scientific and laboratory management needs—so our customers can do what they do best: improve the world around us. Whether a laboratory is engaged in environmental testing, academic research, medical diagnostics, pharmaceuticals, petrochemicals or food testing, Agilent provides laboratory solutions to meet their full spectrum of needs. We work closely with customers to help address global trends that impact human health and the environment, and to anticipate future scientific needs. Our solutions improve the efficiency of the entire laboratory, from sample prep to data interpretation and management. Customers trust Agilent for solutions that enable insights...for a better world.

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