Sr. Quality Assurance Specialist

Role Summary

Senior QA Specialist to support biologics manufacturing operations, ensuring compliance with cGMP standards, internal procedures, and regulatory requirements.

Responsibilities

• Provide on-the-floor QA support for manufacturing operations across all production areas.
• Perform electronic batch record review and QA approval of in-process and finished product documentation.
• Review GMP documentation for product disposition including inventory verifications, batch records, investigations, change control, laboratory reports, validation protocols and reports, calibration and maintenance documentation and batch summary reports.
• Support internal and external audits.
• Support environmental monitoring investigations and aseptic process assessments.
• Support root cause analysis and corrective/preventive actions for complex quality events.
• Collaborate cross-functionally‚Äîincluding Process Dev, QC, Manufacturing, and Validation‚Äîto support scale‚Äëup, tech transfer, and inspection readiness.
• Support raw material and lot release activities and quality system updates as needed.
• Represent Quality for technology transfers and new product introductions.
• Work with accuracy, urgency and a continuous improvement perspective.

Qualifications

• Bachelor‚Äôs degree in life science, biology, biotechnology, or a related scientific discipline.
• 5+ years of experience in QA or QC within a biologics or pharmaceutical manufacturing environment.
• Previous experience working in a GMP regulated facility.
• Familiarity with large molecule drug substance manufacturing, cleanroom practices, and microbiological testing methods.
• In depth understanding of cGMP, FDA, and EU regulatory requirements.
• Excellent communication, documentation, and organizational skills.
• Ability to make key quality decisions on the floor.
• Ability to work independently and collaborate effectively with cross-functional teams.
• Familiar with Master Control, LIMS and Kneat applications.