Quality Control Principal Analyst

Job Description

Position Summary

This position is responsible for performing routine and complex techniques associated with daily QC release and provides investigative and technological orientation in implementing, executing and interpreting quality procedures and test methods. The successful candidate will substantially contribute to process and method improvements within the Quality Control laboratory.

• Perform UV-Vis spectrophotometry assays, LCS, HPLC/GC/SDS‑PAGE methods for in-process and final product samples.
• Perform maintenance on complex laboratory equipment including HPLC and GC systems.
• Investigate and troubleshoot Quality Control methods.
• Review QC data for compliance with procedures and specifications.
• Prepare statistical analysis of results and investigations related to 005/00T 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 documentation for new and current procedures and technical reports.
• Implement new technologies and instrumentation in the QC laboratory.
• Assume a leadership role in the QC laboratory.
• Provide technical leadership and guidance for major laboratory projects, including implementation of new quality control procedures and transfer of new methods.
• Identify deviations from QC methods and develop appropriate CAPAs.
• Recommend method improvements.
• Contribute to the interpretation of results and impact on products and methods.
• Represent QC as the primary 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.
• Operate in compliance with cGMPs.

• Experience with Dionex, GC, HPLC, gel electrophoresis, UV‑Vis spectroscopy and wet chemistry.
• Experience with Empower software.
• Bachelor’s Degree in life sciences and at least 6 years of experience in a cGMP lab environment, or Master’s Degree in life sciences and at least 4 years of experience in a cGMP lab environment.
• Proficient in MS Office and laboratory data management systems.
• Ability to present technical data.
• Ability to work independently on scientific projects.
• Familiarity with USP and global compendia regulations.
• Scientific technical writing ability, including authoring and revising SOPs and technical reports.
• Experience troubleshooting assay and equipment issues.

All your information will be kept confidential according to EEO guidelines.