The QC Analyst is responsible for performing chemical and analytical testing to support Quality Control operations in a GMP-regulated laboratory environment. The role focuses heavily on HPLC analysis to ensure product quality, regulatory compliance, and adherence to internal procedures.
Key ResponsibilitiesPerform routine and non-routine chemical analysis using HPLC in accordance with approved analytical methods and GMP requirements
Accurately review, interpret, and document analytical data in laboratory notebooks, worksheets, and electronic systems
Ensure timely completion of testing activities while maintaining data accuracy and integrity
Support troubleshooting of analytical methods and assist with basic method optimization when required
Perform HPLC system setup, operation, and shutdown following established procedures
Execute equipment qualification, calibration, and routine maintenance activities for HPLC systems
Support Out of Specification (OOS), Out of Trend (OOT), and deviation investigations related to analytical testing
Ensure compliance with data integrity principles, including ALCOA+ requirements
Follow laboratory safety practices and GMP guidelines at all times
Collaborate with Quality Control, Quality Assurance, and cross-functional teams to support laboratory operations and project timelines
Participate in audits, inspections, and continuous improvement initiatives as required
Bachelor's degree in Chemistry, Pharmaceutical Sciences, or a related scientific discipline
Prior experience working as a QC Analyst or in a similar analytical role within a GMP-regulated environment
Strong hands-on experience with HPLC techniques, including method execution and data review
Solid understanding of GMP regulations and Quality Control laboratory practices
Experience with laboratory documentation, analytical investigations, and regulatory compliance
Exposure to OOS, OOT, and deviation investigations
Familiarity with electronic laboratory systems and data management tools
Experience supporting method troubleshooting or method validation activities
Strong attention to detail and high level of accuracy
Ability to work independently as well as collaboratively within a team environment
Effective problem-solving and analytical thinking skills
Clear written and verbal communication skills
Ability to manage multiple tasks and meet deadlines in a regulated setting
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