QA Specialist _ Supplier Quality

Cencora, Inc.; Columbus (OH); On-site; USD 85,000 - 110,000; Full time

Job summary

Columbus, OH - Cencora, Inc. recherche un QA Specialist - Supplier Quality pour soutenir les activités d’assurance qualité des fournisseurs et veiller à la conformité des matières et services.

Vous effectuerez des évaluations fournisseurs, des audits, et assurerez le suivi des actions correctives et préventives. Le candidat idéal possède au moins 3 ans d’expérience dans un environnement réglementé et une connaissance approfondie des GMP; un diplôme de sciences de la vie et une certification CQA

Qualifications

• Baccalauréat ou diplôme équivalent et expérience dans un environnement réglementé (GxP/GDP, GMP).
• Connaissances GMP, qualification des fournisseurs, audits et accords qualité et pharmacovigilance.
• Expérience minimum de 3 ans en Assurance Qualité, Qualité Fournisseurs, Systèmes de Qualité ou fonction qualité associée.
• Connaissance des exigences réglementaires et des procédures internes.
• Excellente aptitude à la documentation traçable et auditabilité.

Responsibilities

• Soutenir la qualification et l’audit des fournisseurs pour assurer la conformité.
• Maintenir les dossiers qualité, les rapports d’audit et les indicateurs de qualité des fournisseurs.
• Participer aux actions correctives et préventives et suivre leur clôture.
• Travailler avec les équipes qualité, achat, production et affaires réglementaires.
• Communiquer les exigences qualité et soutenir les activités liées à la chaîne d’approvisionnement.
• Conduire ou assister aux audits fournisseurs et au monitoring des performances.
• Assurer la traçabilité et la conformité documentaire et les rapports de révision.
• Contribuer au processus d’amélioration continue et à la gestion des incidents qualité.

Skills

Documentation discipline

Communication skills

Attention to detail

Quality system requirements

GMP knowledge

Auditing

Quality management systems (QMS)

Regulatory requirements

Education

Bachelor’s degree in life sciences / related field

CQA Certification

ISO 9001 Lead Auditor (preferred)

Equivalent combination of education and experience

Job description

QA Specialist \\_ Supplier QualityNous utilisons des témoins et des technologies de suivi pour vous offrir une meilleure expérience de navigation, analyser le trafic sur le site et améliorer le site Web.# AmerisourceBergen Carrières - Commencez ici un avenir plus sain!## QA Specialist \\_ Supplier QualityPostuler: Columbus, OH: Temps Plein: Publié aujourd'hui: R2616660Our team members are at the heart of everything we do. At Cencora, we are united in our responsibility to create healthier futures, and every person here is essential to us being able to deliver on that purpose. If you want to make a difference at the center of health, come join our innovative company and help us improve the lives of people and animals everywhere. Apply today!# **Job Details**The Supplier Quality Specialist supports the quality and compliance of materials and services provided by suppliers for American Health Packaging, a Cencora business. This role is primarily responsible for performing supplier evaluations, audit activities, quality documentation, supplier performance monitoring, and issue resolution to help ensure supplier adherence to applicable industry standards, internal procedures, and regulatory requirements. The Specialist works cross-functionally with Quality Assurance, Procurement, Manufacturing, and Regulatory Affairs to support supplier qualification, maintain quality records, monitor supplier quality performance, and assist with corrective and preventive action activities. The successful candidate must demonstrate strong documentation discipline, effective communication skills, attention to detail, and the ability to apply quality system requirements within pharmaceutical, packaging, or healthcare-regulated environments. Some travel will be required to support supplier audits and related supplier quality activities. * Training and Support: Assist with training and guidance for internal teams and suppliers on quality standards, procedures, documentation expectations, and regulatory compliance requirements.* Supplier Evaluation and Qualification: Perform supplier assessments, qualification activities, and audit preparation to evaluate quality management systems, capabilities, and compliance with applicable standards.* Supplier Quality Program Support: Assist with maintaining supplier quality processes, procedures, records, and program requirements in alignment with corporate policies and regulatory expectations.* Supplier Audits and Monitoring: Participate in supplier audit planning, execution, follow-up, and monitoring activities to help identify risks, track findings, and verify timely closure of supplier commitments.* Performance Metrics: Track and analyze supplier quality indicators, including audit outcomes, deviations, complaints, CAPA status, and other performance trends that support continuous improvement.* Issue Resolution: Support investigations of supplier-related quality events and assist with documentation, coordination, and follow-up of corrective and preventive actions.* Cross-Functional Collaboration: Partner with Quality Assurance, Procurement, Manufacturing, and Regulatory Affairs to communicate supplier quality requirements and support supplier-related quality activities.* Documentation and Reporting: Maintain accurate supplier quality records, audit documentation, quality incident files, SOPs, work instructions, and management review inputs as assigned.* Regulatory Compliance: Maintain awareness of applicable regulations, standards, and internal procedures to support compliant supplier quality management practices.* Continuous Improvement: Support quality improvement initiatives by identifying trends, recommending process improvements, and promoting consistent supplier quality practices.**Education:** * Bachelor’s degree is required; an equivalent combination of education and directly relevant experience may be considered. **Experience:** * CQA (Certified Quality Auditor) Certification is required at time of hire or must be obtained within one year of hire date.* Minimum of 3 years of experience in Quality Assurance, Supplier Quality, Quality Systems, or a related quality function within pharmaceutical manufacturing, pharmaceutical packaging, healthcare, or another regulated environment is required.* Demonstrated working knowledge of GMP requirements, supplier qualification, auditing, quality and pharmacovigilance agreements, deviations, complaints, CAPA, documentation practices, and quality management system processes is required. Bachelor's degree in life sciences, business administration, supply chain, or a related field or equivalent experience required.2+ years of experience in quality assurance/quality management within a regulated and/or operational services environment (e.g., GxP/GDP, logistics/distribution), or a related field required.Certified ASQ Certified Quality Auditor (CQA), ISO 9001 Lead Auditor (QMS), or equivalent preferred.Working knowledge of GCP, GMP, GDP, and applicable quality and regulatory requirements relevant to the role.Ability to work under general guidance and prioritize assigned workload within a defined plan.Ability to identify straightforward issues, apply established methods or precedents, and escalate atypical items with supporting context.Ability to maintain accurate, auditable, and traceable documentation to support compliance and effective handoffs.Effective written and verbal communication skills to clarify requirements, provide status updates, and coordinate within the function.Strong organizational skills and attention to detail to manage records, action tracking, and review inputs consistently.Proficiency in Microsoft Office applications and quality management systems, with the ability to use standard tools and reports to support execution and reporting.Full command of English language, written and oral.Proficiency with standard productivity tools and Quality Management Systems (QMS).# ******What Cencora offers******We provide compensation, benefits, and resources that enable a highly inclusive culture and support our team members’ ability to live with purpose every day. In addition to traditional offerings like medical, dental, and vision care, we also provide a comprehensive suite of benefits that focus on the physical, emotional, financial, and social aspects of wellness. This encompasses support for working families, which may include backup dependent care, adoption assistance, infertility coverage, family building support, behavioral health solutions, paid parental leave, and paid caregiver leave. To encourage your personal growth, we also offer a variety of training programs, professional development resources, and opportunities to participate in mentorship programs, employee resource groups, volunteer activities, and much more. For details, visit https://www.virtualfairhub.com/cencoraTemps Plein