Job Summary:
We are seeking an experienced and knowledgeable Quality Assurance (QA) Auditor to support our cGMP Supplier Quality operations and external audit program, as needed.
Reporting to the Vice President of Quality, the QA Auditor will support the execution of Suppler Quality Management (SQM) and Audit Programs for late-stage clinical operations. This role will ensure supplier qualifications and external audits are performed in a timely manner to meet quality and business objectives.
The ideal candidate will have three to five years of supplier quality experience in GMP-regulated environments, with demonstrated expertise in supplier qualification, audit execution, and quality oversight.
Key Responsibilities
Collaborate with QA leadership to enhance and maintain procedures related to the selection, qualification and ongoing management of GMP suppliers, as well as the execution of the external audit program.
Maintain GMP vendor files and the Approved Supplier List (ASL), and perform periodic assessment to ensure all vendor certifications, licenses, and required documentation remain current and compliant.
Support the drafting, review, and maintenance of Quality Technical Agreements, as required.
Apply auditing expertise to support the supplier and external audit schedule, including developing audit plans and conducting routine quality audits of GMP suppliers and service providers.
Maintain accurate and up-to-date audit reports, audit responses, and associated corrective and preventive actions (CAPAs).
Conduct follow-ups on supplier audit corrective actions to ensure timely and effective closure.
Support the QA Operations team in the investigation of product quality complaints, quality events, incidents and CAPAs related to materials or supplier-provided services.
Write, revise, and review Standard Operating Procedures (SOPs) and other GMP documentation in support of continuous improvement initiatives to enhance Supplier Quality efficiency and compliance.
Qualifications, Experience & Competencies
Bachelor’s degree in a Life Sciences discipline preferred.
Minimum of three (3) years of Supplier Quality experience working within a cGMP-regulated Quality Assurance environment; cell therapy experience preferred
Current auditor certification (i.e., ASQ Certified Quality Auditor) strongly preferred
Demonstrated knowledge and practical application of GMP principles, including 21 CFR parts 210 and 211, as they relate to supplier quality oversight.
Ability to work independently with minimal supervision while managing multiple priorities effectively.
Strong interpersonal and collaboration skills, with a demonstrated ability to work in a team-based environment.
Ability to apply a risk-based approach to supplier qualification, auditing, and quality decision-making.
Willingness and ability to travel up to one week per month to support on-site supplier and external audits.
Kaztronix is an equal opportunity employer and does not discriminate on the basis of race, color, national origin, sex, age, religion, disability, veteran status or any other consideration made unlawful by federal, state or local laws. In addition, all human resource actions in such areas as compensation, employee benefits, transfers, layoffs, training and development are to be administered objectively, without regard to race, color, religion, age, sex, national origin, disability, veteran status or any other consideration made unlawful by federal, state or local laws.
By applying to the position, you acknowledge that your information will be used by Kaztronix in processing your application.
