Quality Assurance Specialist - Contractor at Kriya Therapeutics Inc – Morrisville, North Carolina

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

The Quality Assurance Specialist Contractor position supports Manufacturing and Supply Chain operations by providing reviews of batch production records and documents, raw material and consumable inspection and release, review and approval of product shipments from the warehouse. This position will regularly gown into the manufacturing suites during processing activities and observe activities, review documents, and provide cGMP guidance as needed. This position will work closely with the Manufacturing and Supply Chain teams to ensure any observed errors are corrected within a timely manner for batch disposition. This position also provides various administrative support of Kriya’s Quality Management Systems through document scanning, organization of files, and other document control support as needed.

How You Contribute

• Review executed batch production records and applicable documents, which may include but are not limited to e-logbooks, paper logbooks, EM data, equipment printouts.
• Perform Grade C/D level gowning into the manufacturing suites and provide real time review of the records, changeover activities, and walk-throughs of the suites.
• Provide cGMP and quality guidance to help resolve issues that occur during processing.
• Provide Quality Assurance review and disposition of consumables and raw materials.
• Coordinate with Manufacturing and Supply Chain on completion of corrections in a timely manner and prepare completed batch documentation for disposition.
• Provide administrative support for the QMS system as required.
• Perform area inspections of the manufacturing suites and warehouse area on a routine basis.
• Identify and implement continuous improvement initiatives and participate in improvement activities.
• Other quality assurance duties to support batch production release, as necessary.

What You Bring to the Team

Education & Experience

• Minimum – bachelor’s degree preferably in a science, engineering or related field and Biotechnology coursework.
• 1-2 years working in a Quality position in a GMP environment, preferably with grade C/D level gowning experience.

Competencies

• Thorough knowledge of cGMPs and biotechnology derived product regulations.
• Experience working in a cleanroom environment and comfortable with gowning and overseeing GMP processing and aseptic techniques.
• Ability to manage daily work activities of this role with minimal supervision.
• Strong orientation for quality and cGMPs.
• Strong collaborative skills.
• Highly self-motivated and detail oriented.
• Demonstrated level of respect for individuals.
• High level of integrity and personal responsibility.

Working Conditions

• Primarily desk-based, generally in an office or home office setting.
• Involves extended periods of sitting and computer use.
• Must be able to don grade C and D level cleanroom gowning and work in a cleanroom environment.
• Must be willing to work outside of normal business hours, as necessary, to support the manufacturing process.

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.

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.