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The Role
Perform supplier qualification, audits, and ongoing monitoring to ensure GMP compliance. Maintain supplier files and approved lists, support internal and client audits, manage audit findings/CAPAs, and contribute to continuous improvement and SOPs. Interface cross-functionally and support inspection readiness.
Summary Generated by Built In
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.
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.
4. Comply with quality and safety management systems including requirements for documentation, training, system use, SOPs, processes and procedures
5. General support required of a company where everyone is expected to perform multiple tasks both inside and outside their department to meet the needs of the business.
Requirements
Travel and Other Responsibilities:
1. Travel as needed to complete supplier onsite audits; must be willing and available to support audits off-site.
2. 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:
1. Bachelor’s Degree or equivalent experience
2. Minimum of 1 year of pharmaceutical experience is desired, preferably within a Quality role.
3. Experience with auditing and supplier qualification is highly desirable.
Benefits
- Dental insurance - effective day one of employment
- Health insurance - effective day one of employment
- Vision insurance - effective day one of employment
- Health savings account
- Life & AD&D insurance
- Short & long term disability
- Paid time off & holidays
- Employee Assistance Program
- Tuition assistance
- Sam's Club Basic membership reimbursement
- 401(k) with company match
Singota Solutions is an Equal Opportunity Employer
Skills Required
- Bachelor's degree or equivalent experience
- Willingness to travel for onsite supplier audits
- Ability to communicate with suppliers, clients, regulatory bodies, and internal departments
- Analytical mindset to evaluate deviations, CAPAs, and audit findings
- Effective written and verbal communication for audit reports and SOPs
- Ability to interpret and apply GMP and regulatory guidelines
- Capability to manage multiple audits, supplier assessments, and documentation tasks
- Self-motivated to lead audits, initiate quality records, and follow through on observations
- Maintain lead auditor qualification (serve as lead auditor for onsite and internal audits)
- Minimum of 1 year of pharmaceutical experience, preferably in Quality
- Experience with auditing and supplier qualification
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The Company
What We Do
Singota Solutions is a cGMP-compliant and FDA-registered Contract Development and Manufacturing Organization (CDMO) based in Bloomington, Indiana. The company helps clients in the pharmaceutical, animal health, and biotechnology industries accelerate drug development. They specialize in aseptic manufacturing, formulation development, supply chain management, and analytical testing, using robotic technology to produce high-quality injectable medicines in vials, syringes, and cartridges.
