Quality Control Analyst
Agilent Technologies
Summary
Agilent Technologies is looking to add a Quality Control Analyst to its high-performance quality team working at the state-of-the-art, contract API manufacturing facility that specializes in Nucleic Acid Chemistries located in Frederick, Colorado.
Job description
This position coordinates and conducts routine and non-routine testing to support process water monitoring, environmental monitoring, and compressed gas monitoring. Responsibilities also include testing to support cleaning verification for equipment release to support manufacturing activities. Understanding and experience with Standard Operating Procedures, current Good Manufacturing Practices (CGMPs), and other regulatory requirements are required.
The QC Analyst will also work on complex problems to drive improvement. This position requires experience with in-process analysis utilizing analytical instrumentation for UV Analysis, HPLC, and HPLC-MS. The ability to support occasional weekend and evening work is required.
Responsibilities/Duties
- Exercise judgment within broadly defined practices and policies in selecting methods, techniques, and evaluation criteria for obtaining results
- Outstanding communication skills, both written and oral, and the ability to communicate directly with peers and area managers
- Conducts analysis associated with clinical and non-clinical laboratory studies under current Good Manufacturing Practices (cGMP) regulations and guidance per Food and Drug Administration (FDA) and Organization for Economic Co-Operations and Development (OECD)
- Reviews data for compliance to specifications, reports results, and troubleshoots abnormalities
- Troubleshoots, investigates, and resolves laboratory testing failures and drives solutions to improve quality control laboratory programs through corrective and preventive actions
- Ensure equipment is performing well and coordinates preventative maintenance
- Ensure good documentation practices are followed
- May require working with highly potent APIs
Qualifications
- A Bachelor's degree (B.S.) in Chemistry or related life sciences field
- 0-2 years of relevant experience within the Industry
- Exposure and knowledge of FDA regulations and guidelines
- Knowledge of cGMP guidelines or international regulations (i.e., International Committee on Harmonization (ICH) Q7)
- Knowledge of analytical equipment and instrumentation utilized for the testing of in-process samples. This position may require cross-training to test raw material and microbiological samples.
- Proficient with Microsoft Word and Excel
- Familiarity with the following laboratory disciplines is desired: ChemStation, HPLC, and UV analysis
Requirements
- Bachelor's degree (B.S.) in Chemistry or related life sciences field
- 0-2 years of relevant experience within the Industry
- Exposure and knowledge of FDA regulations and guidelines
- Knowledge of cGMP guidelines or international regulations (e.g., ICH Q7)
- Knowledge of analytical equipment and instrumentation utilized for the testing of in-process samples
- Proficient with Microsoft Word and Excel
- Familiarity with ChemStation, HPLC, and UV analysis is desired
Benefits
- Bonus
- Stock
- Medical, Dental & Vision
- 401(k) Matching
Company overview
Agilent Technologies is a global leader in life sciences, diagnostics, and applied markets, delivering innovative solutions that advance scientific discovery and improve quality of life. Founded in 1999 as a spin-off from Hewlett-Packard, the company has grown into a major player in analytical instrumentation and laboratory services. With approximately 18,000 employees worldwide and annual revenues exceeding $6.5 billion, Agilent provides a comprehensive portfolio of instruments, software, services, and consumables that serve laboratories across pharmaceutical, biotechnology, clinical diagnostics, environmental, food safety, and academic research sectors. The company's product offerings span chromatography systems, mass spectrometry, spectroscopy, cell analysis platforms, molecular diagnostics, and laboratory informatics solutions. Agilent's expertise extends beyond hardware to include comprehensive laboratory management services through its CrossLab division, which helps customers optimize laboratory operations, ensure regulatory compliance, and maximize research productivity. The company's commitment to innovation and customer support has made it a trusted partner for scientists and researchers worldwide who rely on Agilent's technologies to address complex analytical challenges and drive scientific breakthroughs.