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
Kriya is an equal opportunity employer
We celebrate diversity and are committed to creating an inclusive environment for all employees
To apply for this job please visit workforcenow.adp.com.