Specialist/Sr. Specialist – Quality Control

SUMMARY:

We are seeking a Quality Control (QC) Specialist/Sr. Specialist to join the Quality Control team at Kriya Therapeutics. This individual will play a critical role in the qualification of new analytical methods for the QC laboratory using a range of technologies, such as HPLC/UPLC, ELISA, qPCR, ddPCR, capillary electrophoresis, and a range of other potential technologies. In addition, the individual will play a key role in the set up and ongoing support a new laboratory information management system (LIMS). They will also own or support change controls and laboratory investigations, as needed.

ESSENTIAL FUNCTIONS:

• Coordinate with the Analytical Development to transfer technical knowledge of new methods to the QC labs
• Own and execute method qualification/validation protocols
• Develop laboratory procedures, electronic notebook (ELN) templates, and supporting training materials
• Support the implementation of a new LIMS system by generating product, project, and stability builds
• Execute routine analytical testing
• Support/address investigations regarding out of specifications (OOS) results, invalid or atypical test results following quality procedures
• Develop, revise, and review general laboratory SOPs and stability protocols and reports as assigned by management
• Train and provide technical assistance and guidance to staff with regards to lab safety and analytical methods
• Ensure continuous lab compliance with applicable cGMP regulations and SOPs, and support regulatory audits

EDUCATION:

• Minimum BS degree in Chemistry, Microbiology, Biological Sciences, or related field with 5+ years of relevant experience

SKILLS AND REQUIREMENTS:

• Experience in developing materials and training QC Analysts in quality principles, procedures and analytical methods/equipment. Hands-on experience with analytical testing in a GMP or GLP environment
• Demonstrated experience in analyzing and interpreting data and information, drawing conclusions and making recommendations
• Strong knowledge of cGMP, SOPs, change controls, deviations, and other quality control processes
• Excellent and effective written, verbal communication and presentation skills

All interested applicants should send a cover letter and resume to [email protected]