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|Quality Control Analyst Representative ( Day Shift )|
Location: Boulder, CO
Employment Type: Full Time
Date Posted: 09/08/2021
Expire Date: 12/19/2021
Job Categories: Biotechnology and Pharmaceutical, Computers, Software, Finance/Economics, Healthcare, Practitioner and Technician, Information Technology, Installation, Maintenance, and Repair, Manufacturing and Production, Military, Executive Management, Quality Control, Research & Development, Medical
Quality Control Analyst Representative ( Day Shift )|
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 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.
At Agilent, we are looking for a proactive Quality Control Analyst Representative to conduct routine, non-routine analysis and review to support release. The expectation for this role is a clear understanding of Good Laboratory Practices (GLPs), cGMPS, and other regulatory requirements.
Essential duties and responsibilities:
Stability testing per Standard Operating Procedures (SOP) and Analytical Methods in accordance with current Good Manufacturing Practices (cGMPs) and regulatory requirements.
Actively engage in continuous improvement of processes and procedures.
Outstanding communication skills, both written and oral, and will be encouraged to communicate directly with project managers and management.
Conducts analysis associated with clinical and commercial under cGMP)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.
Exercises judgment within broadly defined practices and policies in selecting methods, techniques and evaluation criteria for acquiring results.
Follows good documentation practices and reviews data for compliance to specifications and reports, troubleshooting any abnormalities and advancing issues to QC management as appropriate.
Daily maintenance of equipment performance.
* Shift: Monday - Friday, Day Shift
* The Salary range for this position is: $57,440 - $72,000
* Benefits included in brief.
Typically 2-4 years of proven experience for entry to this level
* A Bachelor's degree (B.S.) 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.
* 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.
* Knowledge of analytical equipment and instrumentation, HPLC experience working in a GMP environment is preferred,
* Knowledge of FDA regulations and guidelines.
* Ability to coordinate and lead day to day tasks and working in collaboration to accomplish deadlines and objective while fostering a team environment.
* Works cross functionally to complete projects and testing.
* Experience 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 email@example.com or contact +1-262-754-5030.
For more information about equal employment opportunity protections, please see all of our notices for EEO below.
Equal Opportunity Employer Minorities/Women/Protected Veterans/Disabled