Quality Control Analyst
Agilent Technologies
Summary
The Quality Control Analyst will conduct routine and non-routine analysis and review to support in-process 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.
Job description
Effectively engages in continuous improvement of processes and procedures. Proven ability to exercise judgment and appropriately escalate issues to QC management.
Essential duties and responsibilities
- Outstanding communication skills, both written and oral, and will be expected to communicate directly with 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 in-process samples (developmental and commercial), raw materials, 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
Requirements
- Bachelor's degree (B.S.) in Chemistry or a related life sciences field
- 2-5 years of relevant experience within the Industry
- Exposure to and knowledge of FDA regulations and guidelines
- Knowledge of cGMP guidelines or international regulations (i.e., ICH Q7)
- Knowledge of analytical equipment and instrumentation utilized for the testing of in-process samples
- May require cross-training to support raw material and microbiological testing
- May require handling of highly potent API material
- Proficient with Microsoft Word and Excel
- Familiarity with Chemstation, UV analysis, HPLC, HPLC-MS is highly desired
Benefits
- Bonus
- Stock
- Medical, Dental & Vision
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.