Quality Control Biochem-Chemistry Testing

About the position

We deliver 4.3 billion healthcare solutions to people every year, thanks to the flawless planning and meticulous eye for detail of our Manufacturing & Supply teams. With your talent and ambition, we can do even more to protect people from infectious diseases and bring hope to patients and their families. This Principle Quality Control Analyst is responsible for performing some routine and complex techniques associated with daily QC release and provides an in-depth investigative and technological orientation in implementing, executing and interpreting quality procedures and test methods. Successful candidate will substantially contribute to process and method improvements within the Quality Control laboratory. We are an innovative global healthcare company with one purpose: to chase the miracles of science to improve people's lives. We're also a company where you can flourish and grow your career, with countless opportunities to explore, make connections with people, and stretch the limits of what you thought was possible. Ready to get started?

Responsibilities

• Perform testing on complex laboratory equipment including HPLC, UPLC, Mass Spectrometer and Dionex Ion Chromatography instrumentation.
• Investigate and troubleshoot Quality Control methods.
• Review QC Data for compliance to procedures and specifications.
• Prepare statistical analysis of results.
• Prepare investigations related to OOS/OOT results.
• Participate in training of less experienced staff on new procedures.
• Transfer methods from support groups to the QC laboratory.
• Formulate solutions to laboratory issues through testing of hypotheses.
• Develop and author complex and explicit documentation for new and current procedures and technical reports.
• Implement new technologies/instrumentation in the QC laboratory.
• Provide technical leadership and guidance for the successful completion of major laboratory projects.
• Implement new quality control procedures.
• Transfer and develop new methods.
• Identify deviations from QC methods and develop appropriate CAPAs.
• Recommend method improvements.
• Contribute substantially to the interpretation of results and subsequent impact to product/methods.
• Represent QC as the prime technical contact for laboratory projects.
• Work effectively with others to achieve shared goals and meet timelines.
• Interact with internal and external personnel on technical matters requiring coordination between sites.
• Work independently with minimal to no supervision and direction.

Requirements

• Bachelor's Degree in Life Sciences discipline and 6 years' experience in cGMP lab environment, or Master's Degree in Life Sciences discipline and 4 years' experience in cGMP lab Environment.
• Proficient in MS Office and lab-based data management systems.
• Ability to present technical data.
• Ability to work independently on scientific projects.
• Familiarity with USP and global compendial regulations.
• Scientific technical writing ability including authoring and revising SOPs or technical reports.
• Experience troubleshooting of assay and equipment issues.

Nice-to-haves

• Experience with Dionex, GC, HPLC, Gel Electrophoresis, UV Vis Spectroscopy and wet Chemistry.
• Experience with Empower software.
• Knowledge of lab-based data management systems.

Benefits

• High-quality healthcare.
• Prevention and wellness programs.
• At least 14 weeks' gender-neutral parental leave.