Jobs at Singota Solutions (Now Hiring) — 3 open

Associate Quality Assurance Specialist – Supplier Management

Monroe County, Indiana, United States · On-site

Entry level

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 c…

Skills: Supplier management, GMP compliance, Auditing, Quality assurance, Risk assessment

Singota Solutions

Quality Associate 2 – Batch Release

Monroe County, Indiana, United States · On-site

Mid level

Skills: Batch release, Quality assurance, Good documentation practices, Regulatory compliance, Deviation management

Singota Solutions

Business Development Executive

Monroe County, Indiana, United States · On-site

Senior

Skills: Technical Service Sales, Business Development, Client Relationship Management, Negotiation, Project Planning

Associate Quality Assurance Specialist – Supplier Management

Singota Solutions

Monroe County, Indiana, United States • On-site

Apply

Entry level

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Full-time
bachelor degree
Dental insurance, Health insurance, Vision insurance, Health savings account, Life & AD&D insurance, Short & long term disability
Posted 2d ago
~40 hrs/week

Responsibilities

The Associate Quality Assurance Specialist is responsible for the approval, monitoring, and reassessment of GMP suppliers to ensure regulatory compliance. This role also involves conducting internal and supplier audits, managing quality documentation, and supporting inspection readiness.

Requirements

Candidates should possess a Bachelor's degree or equivalent experience, with at least one year of pharmaceutical experience preferred. Strong communication skills, an analytical mindset, and experience with auditing or supplier qualification are highly desirable.

Full job description

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

Related keywords

GMPQuality AssuranceSupplier ManagementAuditingPharmaCAPADeviationsChange ControlSOPRegulatory ComplianceQuality AgreementsRisk AssessmentInspection ReadinessDocumentationStakeholder Management

About Singota Solutions

LinkedIn Visit site

Focused on Faster

Industry: Pharmaceutical Manufacturing
Company size: 51-200 employees
Founded: 2006
Headquarters: Bloomington, IN
LinkedIn followers: 4,676

Singota Solutions is a cGMP compliant, FDA registered Contract Development and Manufacturing Organization (CDMO), providing the pharmaceutical industry with formulation development, supply chain and materials management, analytical testing, labeling and kitting services, and aseptic manufacturing. Founded in 2006, and headquartered in Bloomington, Indiana, Singota serves 200+ clients offering them superior, quality driven outsourcing services. The company assists its clients in moving their products from “the bench” to the market with quality, speed, reliability, responsiveness, innovation and transparency. Singota is heavily focused on continuously increasing the efficiencies of its services, thereby reducing drug development process lead-times.

Offices: 4320 W Zenith Drive, Bloomington, IN 47404, US

parenteral product testingpharmaceutical storageparenteral production packaging and labelingaseptic fillingclinical manufacturingCDMOpharmaceutical product developmentFDA RegisteredcGMP CompliantTesting

View all jobs at Singota Solutions

About Singota Solutions

LinkedIn Visit site

Focused on Faster

Industry: Pharmaceutical Manufacturing
Company size: 51-200 employees
Founded: 2006
Headquarters: Bloomington, IN
LinkedIn followers: 4,676

Offices: 4320 W Zenith Drive, Bloomington, IN 47404, US

View all jobs at Singota Solutions

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Jobs at Singota Solutions (Now Hiring) — 3 open

Singota Solutions

Associate Quality Assurance Specialist – Supplier Management

Monroe County, Indiana, United States · On-site

Entry level

Skills: Supplier management, GMP compliance, Auditing, Quality assurance, Risk assessment

Singota Solutions

Quality Associate 2 – Batch Release

Monroe County, Indiana, United States · On-site

Mid level

Skills: Batch release, Quality assurance, Good documentation practices, Regulatory compliance, Deviation management

Singota Solutions

Business Development Executive

Monroe County, Indiana, United States · On-site

Senior

Skills: Technical Service Sales, Business Development, Client Relationship Management, Negotiation, Project Planning

Associate Quality Assurance Specialist – Supplier Management

Singota Solutions

Monroe County, Indiana, United States • On-site

Apply

Entry level

Tired of cold applications?

Sign up with Clera and we'll reach out the moment a role actually fits you — no more spraying applications into the void.

Full-time
bachelor degree
Dental insurance, Health insurance, Vision insurance, Health savings account, Life & AD&D insurance, Short & long term disability
Posted 2d ago
~40 hrs/week