Senior Specialist QA – Quality Assurance

About the role

The Senior Specialist, Quality Assurance acts as a technical expert supporting quality systems, validation activities, and regulatory compliance in a regulated manufacturing environment. The role reviews and approves product documentation, validation protocols, environmental reports, and quality records while leading investigations and cross‑functional initiatives.

Key responsibilities

• Review and approve product manufacturing procedures (MPs) and process validation protocols.
• Approve environmental characterization reports and planned incident documentation.
• Release sanitary utility systems in accordance with quality requirements.
• Represent Quality on incident triage and New Product Introduction (NPI) teams.
• Serve as designee for the QA Manager on the local Change Control Review Board (CCRB).
• Collaborate with Manufacturing, Facilities, Utilities, Validation, and Process Development teams.
• Lead investigations and ensure timely closure of quality events.
• Own and maintain site quality program procedures and perform advanced data trending and compliance assessments.

Required profile

• Doctorate + 2 years of directly related experience OR Master’s + 4 years OR Bachelor’s + 6 years OR Associate’s + 10 years OR High School/GED + 12 years.
• Strong knowledge of manufacturing, distribution, QA, QAL, validation, and process development.

Required skills

• KNEAT, CDOCS, SCADA, TrackWise, Maximo.
• Good Documentation Practices (GDP) and Data Integrity compliance.
• Computer System Validation (CSV) and equipment validation.
• Facilities & Utilities commissioning and qualification.
• Risk assessments and risk management.
• SOP development, revision, and document review/approval.