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Carex is partnering with a Pharmaceuticals industry partner to hire a Quality Assurance professional to support the raw materials program within a GMP-regulated environment. 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.
Job Responsibility
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
Review supplier change notifications and assess potential impact
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
Assist with preparation and maintenance of procedural documentation
Track, trend, and analyze raw material quality metrics
Support additional 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
Working knowledge of 21 CFR Parts 210/211, ICH Q7, and global regulatory expectations (FDA, EMA, Health Canada)
Familiarity 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
Nice to have
Familiarity with ICH Q3, Q8, Q9, Q10, and Q11
Experience with EDMS and ERP systems in regulated environments