This Principal QA Specialist is responsible for reviewing and approving GMP data, including in-process, release, and stability test results, ensuring compliance with cGMP and regulatory standards.
They oversee analytical and microbial laboratory activities such as method qualification, transfer, validation, and investigations, providing QA support for deviations, CAPAs, change controls, and projects.
The role involves collaborating with internal teams, supporting audits, and serving as a trainer or mentor for QA staff.
Minimum requirements include a Bachelor's degree with 10+ years or a Master's with 6+ years of QA/QC experience in biopharmaceuticals, strong regulatory knowledge, and interpersonal skills.
Salary ranges from $113,000 to $156,000.