Specialist III, Quality Assurance (Raw Material Qualification)

About the role

This role is a key member of the Supplier Quality team, responsible for supporting supplier qualification, material risk assessment, specification development, and change control activities. The position plays an important role in ensuring compliance with regulatory requirements while contributing to supplier performance monitoring and continuous improvement across pre-clinical, clinical, and commercial manufacturing programs.

Responsibilities

• Support raw material lifecycle management, including drafting, editing, reviewing, and approving specifications and qualification documentation
• Review raw material qualification protocols and reports and ensure adherence to periodic requalification cycles
• Perform risk assessments evaluating impact to product quality, patient safety, and regulatory compliance
• Partner with Supplier Quality Audits to support supplier qualification and requalification activities
• Maintain the Approved Supplier List (ASL) within the eQMS
• Collaborate with suppliers to resolve quality issues, discrepancies, and non-conformances
• Initiate and manage raw material-related change controls
• Manage Supplier Corrective Action Requests (SCARs) in alignment with procedures and agreements
• Support deviation investigations, CAPAs, and root cause analysis for material-related issues
• Provide quality oversight during onboarding and lifecycle management of materials
• Collect and review supplier documentation such as CoAs, CoCs, and compliance statements
• Manage document control activities including scanning, uploading, categorization, and routing within EDMS
• Auxiliary QA activities as needed

Requirements

• Bachelor’s degree in Chemistry, Biology, Biochemistry, or related scientific field preferred
• 5+ years of Quality Assurance experience in a GMP-regulated biotech or pharmaceutical environment
• Strong experience in raw material release, supplier quality, and/or material qualification
• Familiarity with 21 CFR Parts 210/211, ICH Q7, and global regulatory expectations (FDA, EMA, Health Canada)
• Experience with ICH Q3, Q8, Q9, Q10, and Q11 preferred
• Experience with EDMS and ERP systems in regulated environments preferred
• Proficiency in Adobe Acrobat, Microsoft Office, and SmartSheet
• Strong communication skills with the ability to engage professionally with external partners
• Detail-oriented with strong organizational and prioritization skills
• Ability to work independently and manage multiple priorities in a fast-paced environment
• Ability to follow established procedures, policies, and work instructions consistently

Qualifications

• Must be authorized to work in the US (both now and in the future)

Skills

• Strong communication skills
• Detail-oriented
• Organizational and prioritization skills
• Ability to work independently and manage multiple priorities in a fast-paced environment
• Ability to follow established procedures, policies, and work instructions consistently

Benefits

• Commensurate with experience

Pay

• TBD

Schedule

• TBD

Carex Consulting Group is an equal opportunity employer. We are committed to equal employment opportunity regardless of race, color, ancestry, religion, sex, national origin, sexual orientation, age, marital status, disability, gender identity, or Veteran status.