QA Specialist _ Supplier Quality

myhrabc; Columbus (OH); On-site; USD 70,000 - 90,000; Full time

Job summary

Cencora is seeking a Supplier Quality Specialist for American Health Packaging to ensure supplier quality and regulatory alignment across QA, Procurement, Manufacturing, and Regulatory Affairs.

The role involves audits, formal documentation, CAPA support, and continuous improvement in a regulated healthcare environment. Travel to supplier sites may be required.

Qualifications

• Bachelor's degree is required; an equivalent combination of education and directly relevant experience may be considered.
• CQA Certification required at time of hire or within one year of hire date.
• Minimum of 3 years of experience in Quality Assurance, Supplier Quality, Quality Systems, or a related quality function in pharmaceutical packaging, healthcare, or a regulated environment.

Responsibilities

• Perform supplier evaluations, qualification activities, and audit preparation to assess quality management systems and compliance.
• Assist with supplier qualification, maintenance of quality records, and program requirements in line with corporate policies.
• Participate in supplier audit planning, execution, follow-up, and monitoring to identify risks and ensure timely closure of findings.

Skills

Supplier qualification

Auditing

GMP knowledge

CAPA

Documentation

Quality systems

Regulatory requirements

Pharma industry

Cross-functional collaboration

Education

Bachelor's degree in life sciences

Bachelor's degree in business administration

Bachelor's degree in supply chain

Job description

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.
• Bachelor's degree in life sciences, business administration, supply chain, or a related field or equivalent experience required.

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 escrow atypical items with supporting context.
• Ability to maintain accurate, auditable, and traceable documentation to support compliance and ef