Agilent Technologies
Quality Control Analyst
Agilent Technologies, Boulder, Colorado, United States, 80301
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 pmQualifications
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 work in collaboration to accomplish deadlines and objectives.Knowledge of and skills in using computer software and hardware applications, including Microsoft Word and Excel.Pay Range:
$63,840.00-$99,750.00The salary range for this position may differ based on your actual work location.Eligible for Company Car:
NoBenefits in Brief:Travel Required:
NoSchedule:
Full timeShift:
DayDuration:
No End DateJob Function:
Quality/Regulatory
#J-18808-Ljbffr
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 pmQualifications
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 work in collaboration to accomplish deadlines and objectives.Knowledge of and skills in using computer software and hardware applications, including Microsoft Word and Excel.Pay Range:
$63,840.00-$99,750.00The salary range for this position may differ based on your actual work location.Eligible for Company Car:
NoBenefits in Brief:Travel Required:
NoSchedule:
Full timeShift:
DayDuration:
No End DateJob Function:
Quality/Regulatory
#J-18808-Ljbffr