JD262

Job Title: Quality Assurance Specialist – Supplier Management

Department: Quality Assurance

Reports to: Quality Assurance Supervisor

Location: Bloomington, IN (Onsite, only local candidates will be considered)

Position Type: Full-time, exempt

General Description:

The 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 crossfunctional communication and a strong professional presence when interfacing with internal and external stakeholders, clients, and regulatory authorities regarding quality and compliance matters.

Supplier Quality Management:

1. Perform initial assessments and periodic reassessments of applicable GMP suppliers in accordance with Singota policies and procedures.

2. 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.

3. Assign and maintain supplier risk classifications based on the criticality of supplied materials or services, quality history, and audit outcomes.

4. Maintain the approved GMP supplier list in collaboration with other departments.

5. Maintain up-to-date supplier files including audit reports, Quality Agreements, risk assessments, and relevant GMP documentation.

6. Monitor supplier performance via the supplier complaint process and incorporate results into the supplier assessment process. Escalate negative trends to management.

7. Perform routine assessments of supplier change notifications to ensure changes are adequately documented and risks are appropriately assessed.

8. Support the maintenance of Quality Agreements to clearly define roles, responsibilities, and communication pathways.

9. Support continuous improvement initiatives for the supplier management program.

Auditing and Compliance:

1. Serve as a lead auditor for onsite supplier audits and internal audits; maintain lead auditor qualification.

2. Plan, schedule, and execute internal and supplier audits to ensure compliance with applicable GMP regulations.

3. Prepare detailed audit reports outlining observations and classifications (e.g., critical, major, minor) per applicable guidelines and regulations.

4. Support inspection readiness by ensuring supplier documentation and audit records are organized, accurate, and readily accessible.

5. Track and assess responses to audit findings, ensuring timely and appropriate corrective and preventive actions are implemented.

6. Participate in client audits and regulatory inspections in a supporting role.

7. Participate in audit response activities by collaborating with departments and initiating applicable quality records.

8. Participate in deviations, CAPAs, and change controls, as needed.

9. Generate and analyze metrics related to audit performance, supplier compliance, and quality system health; present findings to management as needed.

10. Stay current with changes to GMP regulations and industry best practices; apply knowledge to ensure continued compliance of supplier and audit programs.

11. Write and review Standard Operating Procedures (SOPs) related to the auditing program.

12. Ensure accuracy and compliance of documentation in accordance with company and regulatory guidelines.

Training and Team Collaboration:

1. Participate in the training and onboarding of new Quality Assurance staff.

2. Represent the Quality Assurance function at project and technical meetings, as needed.

3. Collaborate cross-functionally to support audit responses and continuous improvement initiatives.

Travel and Other Responsibilities:

4. Travel as needed to complete supplier onsite audits; must be willing and available to support audits off-site.

5. Perform other duties as assigned by the Supervisor, in alignment with company guidelines and industry best practices.

Characteristics required include:

1. Comfortable communicating with internal departments, external suppliers, clients, and regulatory bodies.

2. Analytical mindset to evaluate complex quality data, deviations, CAPAs, and audit findings.

3. Demonstration of positive attitude and professional presence.

4. Excellent time management to balance audits, reporting, and team responsibilities.

5. Effective written and verbal communication skills, especially for audit reports, SOPs, and cross-functional collaboration.

6. Able to interpret and apply GMP and regulatory guidelines in a practical setting.

7. Capable of managing multiple audits, supplier assessments, and documentation tasks simultaneously.

8. Self-motivated to lead audits, initiate quality records, and follow through to address observations.

9. Capable of working with minimal supervision while meeting deadlines and quality objectives.

10. Adapts to changing schedules and priorities in a dynamic QA environment.

Education and Work Experience Requirements:

Singota Solutions is an Equal Opportunity Employer