Quality Control Analyst

Agilent Technologies•Frederick, MD

About The Position

The Quality Control Analyst conducts routine and non-routine analyses and reviews to support in-process testing in accordance with Standard Operating Procedures, analytical methods, current Good Manufacturing Practices, and regulatory requirements. The role supports clinical and commercial work involving nucleic acid therapeutics and requires understanding of Good Laboratory Practices, cGMPs, and other applicable regulations. The analyst contributes to continuous improvement, exercises judgment in selecting methods and evaluation criteria, and escalates issues appropriately to QC management. The position performs testing on in-process samples, raw materials, and other requested materials; reviews data against specifications; troubleshoots abnormalities; and ensures equipment is performing properly. It requires strong written and verbal communication, including direct communication with management, and adherence to good documentation practices. Cross-training may be required to support raw material and microbiological testing, and the role may involve handling highly potent API material.

Requirements

Bachelor's degree (B.S.) in Chemistry or a related life sciences field.
2–5 years of relevant industry experience.
Exposure to and knowledge of FDA regulations and guidelines.
Knowledge of cGMP guidelines or international regulations, such as ICH Q7.
Knowledge of analytical equipment and instrumentation used to test in-process samples.
Proficiency with Microsoft Word and Excel.
Strong written and oral communication skills.

Nice To Haves

Familiarity with Chemstation.
Familiarity with UV analysis.
Familiarity with HPLC.
Familiarity with HPLC-MS.

Responsibilities

Conduct routine and non-routine analysis and review to support in-process testing in accordance with SOPs, analytical methods, cGMPs, and regulatory requirements.
Perform analyses for clinical and commercial work under applicable GMP regulations and guidance, including FDA, OECD, and international regulations.
Test in-process samples, raw materials, and other materials as requested, following written procedures.
Review data for compliance with specifications and reports, and troubleshoot abnormalities.
Ensure equipment is performing properly, communicate concerns, and take appropriate action.
Follow good documentation practices.
Exercise judgment in selecting methods, techniques, and evaluation criteria, and escalate issues appropriately to QC management.
Engage in continuous improvement of processes and procedures.
Communicate effectively in writing and verbally, including directly with management.