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QC Analyst

QC Analyst

AgilentBoulder, CO, United States
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Job Description

Agilent inspires and supports discoveries that advance the quality of life. We provide life science, diagnostic and applied market laboratories worldwide with instruments, services, consumables, applications and expertise. Agilent enables customers to gain the answers and insights they seek so they can do what they do best : improve the world around us. Information about Agilent is available at www.agilent.com.

Conducts routine and non-routine analysis and reviews of analytical data for raw materials, in-process, release, 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. Completes projects to with supervision. Has a clear understanding of Good Laboratory Practices (GLPs), cGMPS, and other regulatory requirements. Actively engages in continuous improvement of processes and procedures. Proven ability to exercise judgment and appropriately escalates issues to QC management.

Shift : Monday to Friday, 2 : 30 p-11 : 00 pm

ESSENTIAL DUTIES AND RESPONSIBILITIES : includes the following :

  • 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 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

Qualifications

  • A Bachelor's degree (B.S.) or equivalent experience in Analytical Chemistry or related life sciences field
  • 2+ years industry experience and / or training; or equivalent combination of education and experience.
  • Proven knowledge of cGMP guidelines as well as international regulations (i.e., International Committee on Harmonization (ICH) Q7) pertaining to Quality Control programs that support production of APIs, stability and drug product release.
  • Demonstrated knowledge of analytical equipment and instrumentation, HPLC experience working in a GMP environment is preferred
  • Knowledge of FDA regulations and guidelines
  • Proven skills in coordinating and managing day to day tasks and working in collaboration to accomplish deadlines and objectives
  • Personal leadership skills and fosters working in a team environment
  • 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.

    For more information about equal employment opportunity protections, please view the 'EEO is the Law' poster available here :

    https : / / www.dol.gov / ofccp / regs / compliance / posters / pdf / eeopost.pdf,

    https : / / www.dol.gov / ofccp / regs / compliance / posters / pdf / OFCCP_EEO_Supplement_Final_JRF_QA_508c.pdf

    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 contact +1-262-754-5030 (US and Canada only) or email [email protected]. EOE AA M / F / Vet / Disability.

    Additional Details

    This job has a full time weekly schedule. Applications for this job will be accepted until at least September 16, 2025 or until the job is no longer posted.

    The full-time equivalent pay range for this position is $31.92 - $49.88 / 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 : No

    Shift : Day

    Duration : No End Date

    Job Function : Quality / Regulatory

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