Specialist III, Quality Assurance (Raw Material Qualification)

Responsibilities

• Aid in raw material lifecycle management by drafting, editing, reviewing, and approving specifications.
• Review and approve raw material qualification protocols and reports to ensure compliance with periodic requalification cycles.
• Collaborate with internal functional teams to support supplier qualification and requalification as needed.
• Maintain the ASL by providing and entering qualification information into the eQMSC.
• Resolve quality issues, document discrepancies, and non-conformances with suppliers.
• Initiate and manage change controls related to raw materials.
• Manage Supplier Corrective Action Requests (SCARs) per internal procedures and applicable quality agreements.
• Support deviation investigations, CAPAs, and root cause analyses involving material issues.
• Oversee material onboarding and lifecycle management by requesting and reviewing supporting documentation from suppliers.
• Track and trend raw material-related quality metrics.
• Assist with other QA duties as needed.

Requirements

• A BS/BA in Chemistry, Biology, Biochemistry, or a related scientific field is preferred.
• Minimum of 5+ years of Quality Assurance experience in a GMP-regulated biotech or pharmaceutical manufacturing environment, with an emphasis on raw material release, Supplier Quality, and/or material qualification activities.
• Working knowledge of 21 CFR Parts 210/211, ICH Q7, and applicable global regulatory expectations (e.g., FDA, EMA, Health Canada), along with familiarity with relevant regulatory guidance documents.
• Prior experience with use of an Electronic Document Management System (EDMS) and an Enterprise Resource Planning (ERP) software in a regulated environment is preferred.
• Prior experience with use of ICH Q3, Q8, Q9, Q10, and Q11 is preferred.
• Competent knowledge of and ability to use Adobe Acrobat, Microsoft Office applications, and SmartSheet.
• Excellent interpersonal, verbal, and written communication skills.
• Ability to consistently communicate with external parties in a professional manner.
• Excellent attention to detail and organizational skills.
• Ability to work independently with minimal supervision as well as managing priorities within a face-paced environment.