Quality Control Analyst III

At Pharmacyclics, our every effort is directed to bringing new therapies to life: treatments that help people return to the lives they love as quickly and easily as possible. We believe there is nothing more powerful than giving back in this way. We believe there is nothing more valuable than turning hope into reality and allowing people to focus on the splendor in every day. This is what we call the magic of normal—and we want this for as many people as possible.

Working within FDA cGMP regulations, perform testing for release and stability of intermediate product/starting materials, drug substance and drug products.Generate and record testing results accurately and document per applicable regulatory and Standard Operating Procedures (SOP) requirements.

* Perform release and stability testing according to SOPs and in compliance with cGMP regulations and guidelines. * Maintain meticulous laboratory notebook documentation of testing. * Analyze data using Waters Empower and other application software, e.g. Microsoft Excel. * Accurately enter data into Stability Laboratory Information Manager database. * Maintain cGMP compliance in the laboratory. * Participate in method validation and method transfer activities. * Write, revise and/or review SOPs. * Maintain extensive knowledge of SOPs and GMP regulations and guidelines. * Troubleshoot equipment problems.

* BS or MS in Chemistry, Biochemistry, Biology or related field * 2-5 years experience in pharmaceutical industry, preferably in QC * Knowledge of cGMPs related to QC operations * Instrumentation knowledge & experience (HPLC, GC, UV/Vis, NMR, FTIR) * Wet Chemistry * Experience with Waters Empower chromatography data software * Recognize atypical and out-of-specification results, instrument malfunctions, and methodology issues and participate in the investigation process * Excellent written and verbal skills * Ability to work independently and manage multiple analyses