Quality Control Specialist I/II Position Available In Wake, North Carolina

Quality Control Specialist I/II Kriya Therapeutics Inc 4105 Hopson Road, Morrisville, NC 27560 About Kriya Kriya is a biopharmaceutical company whose mission is to develop life-changing gene therapies for diseases affecting millions of patients around the world. We leverage our proprietary computational engine, in-house manufacturing infrastructure, and integrated design platform to engineer technologies and therapeutics with the potential to transform the treatment of a broad universe of diseases of high unmet need, with a focus on metabolic disorders, neurology, and ophthalmology. We are proud to have been named Triangle Business Journal’s Life Sciences 2024 “Best Private Company to Work For,” recognized by Forbes as one of “America’s Best Startup Employers of 2024,” and honored as one of BioSpace’s “2025 Best Places to Work.” Who You Are Individual technical contributor within the Quality Control department responsible for the management of reference standards, controls, and critical reagents. They are expected to set a positive example for junior QC contributors and provide support where necessary. How You Contribute Owns the full lifecycle of all reference standards, controls, and critical reagents within the QC laboratory, including preparing/sourcing, qualification/release, stability assessments, lot-to-lot bridging, and trending. Coordinate with the Analytical Development to transfer technical knowledge of reference standard and select other new method technologies to the QC labs. Own and execute method qualification/validation protocols as assigned by management. Develop laboratory procedures, electronic notebook (ELN) templates, and supporting training materials for assigned projects. Execute routine analytical testing. Support/address investigations regarding out of specifications (OOS) results, invalid or atypical test results following quality procedures for methods within their subject matter expertise. 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. What You Bring to the Team Education & Experience BS degree in Chemistry, Microbiology, Biological Sciences, or related field Advanced degree preferred 5+ years of relevant experience An equivalent combination of education and experience is acceptable Competencies 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 Experience with PCR and cell-based potency assays is preferred 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 Working Conditions Primarily in an office or laboratory setting May involve standing, sitting, and using laboratory equipment for extended periods. Some lifting of equipment or materials may be required. Discover True Collaborative Teamwork We have an ambitious set of goals, but our confidence – and our inspiration – stems from our people. From California to North Carolina, our teammates bring a spirit of Collaboration, Leadership, and Innovation to their work every day. We’re always looking for teammates with the drive and energy to help us grow. If you want to be a part of a company with an entrepreneurial culture, a bold vision, and a meaningful purpose, join us. What We Offer Medical, Dental and Vision 401(k) with Company Match Short and Long-term Disability Benefits Company Paid Holidays Flexible Time Off Cyber Safety protection EAP Life Insurance Equity and more! Kriya is an equal opportunity employer. We celebrate diversity and are committed to creating an inclusive environment for all employees. All job requirements in the job description provided indicate the minimum level of knowledge, skills, and/or abilities deemed necessary to perform the job competently. Job descriptions are an overview of the duties, responsibilities, and requirements of the position. Employees may be required to perform other job-related assignments as requested.