Associate Quality Assurance Specialist – Supplier Management

Associate Quality Assurance Specialist – Supplier Management

Singota Solutions is a contract development and manufacturing organization (CDMO) focused on getting products to patients faster by being agile, accountable, and transparent. Our team of experts believe in collaboration and customizing our services to assist our clients through the drug development process. Our key services include drug formulation development, analytical testing, aseptic filling, pharmaceutical labeling and kitting, and supply chain management.

Why join Team Singota? We pride ourselves on a high-trust, high-accountability environment where we lift each other up. When you join Singota, you are a part of a team that respects, supports, and values its people. We celebrate wins together, brainstorm solutions together, and genuinely enjoy the work we do. The result? A team that's not just efficient, but also passionate, dedicated, and fun to work with.

Job Title:

Associate Quality Assurance Specialist – Supplier Management

Department:
Quality Assurance

Reports to:

Quality Assurance Supervisor

Location:

Bloomington, IN (Onsite)

Position Type:
Full-time, exempt, 40 hr/wk

General Description:

The Associate Quality Assurance Specialist – Supplier Management role will be primarily responsible for completing the approval, monitoring, and reassessment of GMP suppliers to ensure compliance with Singota processes and regulatory standards. This role also supports internal audits, client audits, and regulatory inspections. The position requires effective cross-functional communication and a strong professional presence when interfacing with internal and external stakeholders, clients, and regulatory authorities regarding quality and compliance matters.

• Perform initial assessments and periodic reassessments of applicable GMP suppliers in accordance with Singota policies and procedures.
• Conduct and/or support on-site and remote supplier audits in accordance with applicable guidelines and regulations. Generate audit reports and applicable supplier approval documentation.
• Assign and maintain supplier risk classifications based on the criticality of supplied materials or services, quality history, and audit outcomes.
• Maintain the approved GMP supplier list in collaboration with other departments.
• Maintain up-to-date supplier files including audit reports, Quality Agreements, risk assessments, and relevant GMP documentation.
• Monitor supplier performance via the supplier complaint process and incorporate results into the supplier assessment process. Escalate negative trends to management.
• Perform routine assessments of supplier change notifications to ensure changes are adequately documented and risks are appropriately assessed.
• Support the maintenance of Quality Agreements to clearly define roles, responsibilities, and communication pathways.
• Support continuous improvement initiatives for the supplier management program.

• Serve as a lead auditor for onsite supplier audits and internal audits; maintain lead auditor qualification.
• Plan, schedule, and execute internal and supplier audits to ensure compliance with applicable GMP regulations.
• Prepare detailed audit reports outlining observations and classifications (e.g., critical, major, minor) per applicable guidelines and regulations.
• Support inspection readiness by ensuring supplier documentation and audit records are organized, accurate, and readily accessible.
• Track and assess responses to audit findings, ensuring timely and appropriate corrective and preventive actions are implemented.
• Participate in client audits and regulatory inspections in a supporting role.
• Participate in audit response activities by collaborating with departments and initiating applicable quality records.
• Participate in deviations, CAPAs, and change controls, as needed.
• Generate and analyze metrics related to audit performance, supplier compliance, and quality system health; present findings to management as needed.
• Stay current with changes to GMP regulations and industry best practices; apply knowledge to ensure continued compliance of supplier and audit programs.
• Write and review Standard…