KBI: US - Principal QA Specialist

Position Summary

This individual is responsible for the compliance review of Biopharmaceutical GMP data. This includes the review and approval of in-process, release, and stability test data. The Principal QA Specialist provides QA oversight of analytical and microbial laboratory activities, including but not limited to method qualification, method transfers, method validations, creation and revision of test methods, specifications, stability studies, laboratory investigations, and laboratory deviations.

The role ensures patient safety and regulatory compliance while supporting product lifecycle activities for timely delivery of products to clients for patients. The specialist collaborates with clients, laboratories, manufacturing, QA batch disposition, and other internal stakeholders to achieve site, operational, and department-specific goals, cultivating and maintaining a quality culture. It may also serve as a team lead for specific responsibilities.

• Perform timely review of test data for in-process, release, and stability samples.
• Assure activities comply with required procedures, cGLP, and cGMP requirements.
• Review and approve method verification, transfer, qualification, and validation related to the testing of in-process, release, and stability samples.
• Provide QA support for deviations, CAPAs, laboratory investigations, change controls, and projects related to laboratory processes, instruments, specifications, methods, and SOPs.
• Attend relevant operational meetings in support of manufacturing operations, analysis, and disposition activities.
• Support client audits and regulatory inspections as required.
• Assist with special projects such as implementation of new processes to support site, operational, and department goals.
• Serve as trainer/mentor for QA specialists and cross-trainer for employees in other departments to support individual development goals.
• Perform other activities as assigned by management.

• Bachelor’s degree and 10+ years of experience, or Master’s degree and 6+ years of experience in a QA, QC, or cGMP environment in biopharmaceuticals or equivalent.
• Demonstrated strong interpersonal skills, ability to work in a team environment, attention to detail, and excellent problem-resolution skills.
• Strong understanding of FDA, EU, and cGMP regulations required.
• Experience in quality control and quality systems beneficial.

$113,000 - $156,000

KBI Biopharma, Inc. is an EEO/AA employer and actively seeks to diversify its workforce. Therefore, all qualified applicants, regardless of race, color, national origin, religion, gender, gender identity, sexual orientation, age, disability or veteran status, are strongly encouraged to apply.