Quality Associate 1 - Operations

Singota Solutions; Bloomington (IN); On-site; USD 52,000 - 66,000; Full time

Benefits offered by this job

Dental insurance

Health insurance

Vision insurance

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 reimb

401(k) with company match

Job summary

Singota Solutions in Bloomington, IN, is seeking a Quality Associate 1 - Operations to provide QA oversight and guidance in daily supply chain and manufacturing activities. You will review batch records, perform inspections, and interface with internal teams, clients, and regulators to ensure compliant documentation and processes.

Ideal candidates have a science background and 1–3 years pharma QA exposure, including aseptic manufacturing and GDP adherence.

Qualifications

• Bachelor’s degree or equivalent experience in a science-related field.
• 1–3 years pharmaceutical experience is desired, preferably in a quality role.
• Experience with aseptic manufacturing and supply chain operations is highly desirable.

Responsibilities

• Provide on-the-floor QA support for Manufacturing and Supply Chain including in-process batch review and documentation oversight.
• Perform and/or oversee quality inspections of labels, components, filled vials, and packaging.
• Review sampling, dispensing, shipping, and receiving material packets for GDP adherence.
• Perform AQL sampling on products/materials and maintain inspection status.
• Collaborate with suppliers to oversee shipping qualification studies and review protocols/reports.
• Change status of material and finished product in the inventory system.
• Become gowning qualified to perform QA functions in cleanrooms.
• Process shipments and receipts of controlled substances and maintain status as authorized personnel.
• Represent QA at project/technical meetings as needed.
• Author deviations, CAPAs, and change controls as needed.
• Write/review SOPs related to Quality systems in SCM and Manufacturing.
• Perform other duties as assigned and ensure compliance with SOPs and regulatory standards.
• Comply with quality and safety management systems and collaborate with other departments.

Skills

Positive attitude

Strong work ethic

Time management

Communication skills

Team player

Education

Bachelor’s degree or equivalent experience in science-related field

Job description

Bloomington, United States | Posted on 08/21/2026

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: Quality Associate 1 - Operations

Department: Quality Assurance

Position Type: Full-time, non- exempt

Reports to: Quality Assurance Supervisor

Location: Bloomington, IN (Onsite)

General Description:

The Quality Associate 1-Operations position provides Quality oversight, assistance and guidance in daily operations related to Supply Chain Management and Manufacturing. This position is primarily responsible for ensuring compliance and accuracy of all documentation and data related to the release of materials for shipping and receiving. This role is also responsible for providing oversight and in-process reviews of Manufacturing batch records and related documentation. This role must also positively interface with internal key stakeholders, clients and regulatory agencies regarding quality and regulatory issues.

1. Provide on the floor QA support for Manufacturing and Supply Chain including in-process batch record review, room release, equipment release, logbook and documentation review, and process oversight.

2. Perform and/or oversee quality inspections including, but not limited to: labels, components, filled vials, and packaging.

3. Assist with the review of sampling, dispensing, shipping, and receiving material packets for GDP adherence.

4. Perform Acceptable Quality Limit (AQL) sampling on products/materials and maintain visual inspection qualification status.

5. Collaborate internally as well as with applicable suppliers to provide oversight for shipping qualification studies. Oversight includes review and approval of supplier provided protocols and reports.

6. Perform status change of material and/or finished product per the validated inventory management system.

7. Become gowning qualified to perform Quality functions within the cleanrooms (line clearances, batch execution support).

8. Process shipments and receipts of controlled substances, maintain qualification status as controlled substance authorized personnel.

9. Represent Quality Assurance at various project and technical meetings, as needed.

10. Author deviations, CAPAs, and change controls as needed.

11. Write and review Standard Operating Procedures related to Quality systems within Supply Chain Management and Manufacturing.

12. Perform other duties as assigned by the Quality Manager. Perform all responsibilities in accordance with company guidelines and Standard Operating Procedures and appropriate industry and regulatory standards and guidelines.

13. Comply with quality and safety management systems including requirements for documentation, training, system use, SOPs, processes and procedures

14. Work in collaboration with other departments to meet the needs of the business.

Requirements

Characteristics required include:

1. Demonstration of positive attitude and professional presence.

2. Strong work ethic and the ability to work in a fast-paced environment.

3. Demonstration of good organizational and time management skills.

4. Good communication skills, adept at working individually and as a team.

Work Experience and Education Requirements and Preferences:

1. Bachelor’s Degree or equivalent experience- science related field preferred.

2. Minimum 1-3 years pharmaceutical experience is desired, preferably in a Quality role.

3. Experience with aseptic manufacturing and supply chain operations is highly desirable.

• 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

Singota Solutions is an Equal Opportunity Employer and does not discriminate on the basis of race or ethnicity, religion, sex, national origin, age, veteran disability or genetic information or any other reason prohibited by law in employment.