QA Specialist _ Supplier Quality

Cencora, Inc.; Columbus (OH); Vor Ort; USD 85.000 - 120.000; Vollzeit

Zusammenfassung

Cencora, Inc. is seeking a Supplier Quality Specialist to support materials and services from suppliers for American Health Packaging, a Cencora business.

The role involves supplier evaluations, audits, documentation, performance monitoring, and CAPA to ensure GMP-compliant supply chains in a regulated healthcare environment. You will work with Quality Assurance, Procurement, Manufacturing, and Regulatory Affairs; travel to supplier sites is expected.

Qualifikationen

• Bachelor’s degree required; relevant experience considered.
• 3+ years in QA, supplier quality, or related regulated environment.
• GMP/GCP/GDP knowledge and supplier qualification experience required.

Aufgaben

• Assist with training internal teams and suppliers on quality standards and regulatory compliance.
• Perform supplier assessment, qualification activities, and audits.
• Maintain supplier quality records and program documentation.
• Monitor supplier quality performance and CAPA status.
• Support investigations of quality events and corrective actions.
• Collaborate with QA, Procurement, Manufacturing, and Regulatory Affairs.
• Maintain regulatory awareness to support compliant supplier quality practices.
• Support continuous improvement initiatives in supplier quality processes.

Kenntnisse

Quality Assurance

Auditing

Documentation discipline

Cross-functional collaboration

Regulatory compliance

Attention to detail

Ausbildung

Bachelor’s degree (life sciences, chemistry, biology, or related)

CQA Certification

ISO 9001 Lead Auditor (QMS)

GMP/GDP knowledge

Tools

Microsoft Office

Quality Management Systems (QMS)

Jobbeschreibung

Our 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.

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 escape 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/cencora

Full time

Equal Employment Opportunity

Cencora is committed to providing equal employment opportunity without regard to race, color, religion, sex, sexual orientation, gender identity, genetic information, national origin, age, disability, veteran status or membership in any other class protected by federal, state or local law.

The company’s continued success depends on the full and effective utilization of qualified individuals. Therefore, harassment is prohibited and all matters related to recruiting, training, compensation, benefits, promotions and transfers comply with equal opportunity principles and are non-discriminatory.

Cencora is committed to providing reasonable accommodations to individuals with disabilities during the employment process which are consistent with legal requirements. If you wish to request an accommodation while seeking employment, please call 888.692.2272 or email [e-mail]. We will make accommodation determinations on a request-by-request basis. Messages and emails regarding anything other than accommodations requests will not be returned

Affiliated Companies

Affiliated Companies: Amerisource Health Services, LLC