Quality Control Analyst

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, 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 escalates 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

Qualifications

• Bachelor’s Degree or equivalent experience in Analytical Chemistry or related life sciences field with one to three years related experience and/or training; or equivalent combination of education and experience

• 1+ years relevant experience

• 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 is helpful

• Demonstrated knowledge of analytical equipment and instrumentation, HPLC experience working in a GMP environment is preferred

• Ability 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 Excel

#LI-DT1

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 [email protected] or contact +1-262-754-5030.

For more information about equal employment opportunity protections, please visit www.agilent.com/en/accessibility.

Pay Range$63,840.00-$99,750.00

The salary range for this position may differ based on your actual work location.

Eligible for Company Car

No

Benefits in Brief

Travel RequiredNo

ScheduleSchedule:Full time

ShiftDay

DurationNo End Date

Job FunctionQuality/Regulatory