QC Analyst II at Agilent Technologies in Boulder, Colorado

Job Description:

Job Function
Quality/Regulatory

Travel Required
Occasional

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.

The world's most revolutionary biopharma companies are partnering with Agilent Technologies to advance the next frontier of medicine. Agilent continues to invest in the 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, life-saving medicines.

The Quality Control Analyst II conducts routine/non-routine analysis and review to support in-process, release, stability and raw materials according to Standard Operating Procedures (SOP) and Analytical Methods in accordance with current Good Manufacturing Practices (cGMPs) and regulatory requirements. Completes projects 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.

Duties and Responsibilities include 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.


• Exercises judgment within broadly defined practices and policies in selecting methods, techniques and evaluation criteria for obtaining results.

Job Type
Experienced

Shift
Day Shift

Qualifications

• Bachelors or Masters Degree or University Degree or equivalent.


• 4+ years relevant experience for entry to this level


• 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 the 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.

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 see all of our notices for EEO below.

Option to Work Remote
Yes

Schedule
Full-time

Secondary Locations
US-CO-Frederick All Buildings