Specialist III, Quality Assurance (Raw Material Qualification)

Quality Assurance ProfessionalCarex 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.What You'll DoSupport raw material lifecycle management, including drafting, editing, reviewing, and approving specifications and qualification documentationReview raw material qualification protocols and reports and ensure adherence to periodic requalification cyclesPerform risk assessments evaluating impact to product quality, patient safety, and regulatory compliancePartner with Supplier Quality Audits to support supplier qualification and requalification activitiesMaintain the Approved Supplier List (ASL) within the eQMSCollaborate with suppliers to resolve quality issues, discrepancies, and non-conformancesReview supplier change notifications and assess potential impactInitiate and manage raw material-related change controlsManage Supplier Corrective Action Requests (SCARs) in alignment with procedures and agreementsSupport deviation investigations, CAPAs, and root cause analysis for material-related issuesProvide quality oversight during onboarding and lifecycle management of materialsCollect and review supplier documentation such as CoAs, CoCs, and compliance statementsManage document control activities including scanning, uploading, categorization, and routing within EDMSAssist with preparation and maintenance of procedural documentationTrack, trend, and analyze raw material quality metricsSupport additional QA activities as neededWhat You'll BringBachelor's degree in Chemistry, Biology, Biochemistry, or related scientific field preferred5+ years of Quality Assurance experience in a GMP-regulated biotech or pharmaceutical environmentStrong experience in raw material release, supplier quality, and/or material qualificationWorking 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 preferredExperience with EDMS and ERP systems in regulated environments preferredProficiency in Adobe Acrobat, Microsoft Office, and SmartSheetStrong communication skills with the ability to engage professionally with external partnersDetail-oriented with strong organizational and prioritization skillsAbility to work independently and manage multiple priorities in a fast-paced environmentAbility to follow established procedures, policies, and work instructions consistentlyCarex 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.