Quality Associate 2 - Batch Release

Singota Solutions; Bloomington (IN); On-site; USD 65,000 - 90,000; Full time

Benefits offered by this job

Dental insurance

Health insurance

Vision insurance

Health savings account

Life & AD&D insurance

Disability insurance

Paid time off & holidays

Employee Assistance Program

Tuition assistance

Sam's Club membership reimbursement

401(k) with company match

Job summary

Singota Solutions in Bloomington, IN is seeking a Quality Associate 2 – Batch Release to manage batch records and release activities in a QA-driven environment.

The role requires a science-related bachelor’s degree and 3–5 years of pharmaceutical experience, with GDP knowledge and aseptic manufacturing exposure preferred.

Qualifications

• Bachelor’s degree in a science-related field or equivalent.
• 3–5 years pharmaceutical experience, preferably in a Quality role.
• Knowledge of Good Documentation Practices (GDP).
• Experience in aseptic manufacturing and laboratory operations is desirable.

Responsibilities

• Responsible for the issuance, review, and release of batch records and protocols.
• Disposition of materials within the electronic inventory management system and release documentation.
• Collaborate with various departments to ensure record specifications are accurate and deviations are investigated.
• Interface with clients to provide support for review and release of records related to client material or product.
• Author complex deviations, CAPAs, and change controls as needed.
• Participate in the training of new Quality Assurance staff.
• Support continuous improvement of the site’s Quality Systems.
• Generate and issue controlled labeling material for manufacturing operations; review for legibility and compliance.
• Review and disposition Quality Control/Development Laboratory records.
• Write and review SOPs related to Quality Systems within Manufacturing and QC/Development.
• Develop and issue Quality operational metrics.
• Represent Quality Assurance at project and technical meetings.
• Perform other duties as assigned by supervision.

Skills

Excellent communication

Positive attitude

Time management

Attention to detail

Education

Bachelor’s degree or equivalent – science

Job description

Bloomington, United States | Posted on 07/29/2026

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 2 – Batch Release

Department: QA

Reports to: Quality Assurance Supervisor

Location: Bloomington, IN (Onsite)

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

General Description:

The Quality Associate 2 – Batch Release is responsible for managing the workflow of records for Manufacturing and QC/Development activities in accordance with company, client and regulatory quality standards, including the appropriate disposition of materials or manufactured product. This position is responsible for reviewing records for accuracy and completeness and for identifying discrepancies or issues that could result in product impact.

1. Responsible for the issuance, review, and release of batch records and protocols. Ensure records are executed in accordance with procedures and regulatory requirements.

2. Perform disposition of materials within the electronic inventory management system, issue appropriate release documentation.

3. Collaborate with various departments to ensure record specifications are accurate and related deviations are thoroughly investigated.

4. Interface with clients to provide support for review and release of records related to client material or product.

5. Author complex deviations, CAPAs, and change controls as needed.

6. Participate in the training of new Quality Assurance staff.

7. Support continuous improvement of the site’s Quality Systems.

8. Generate and issue controlled labeling material for manufacturing operations. Review for legibility, accuracy, and compliance to company, client, and regulatory standards.

9. Review and disposition Quality Control/Development Laboratory records.

10. Write and review Standard Operating Procedures related to Quality Systems within Manufacturing and QC/Development.

11. Responsible for the development and issuance of Quality operational metrics.

12. Represent Quality Assurance at various project and technical meetings.

13. Must perform other duties as assigned by supervision. Responsible for notifying supervision when issues arise.

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

Requirements

Skills and Physical Activity Requirements:

1. Excellent internal and external communication.

2. Demonstration of positive attitude and professional presence.

3. Good time management and organizational skills.

4. Detail orientated, must be able to perform thorough reviews of documentation.

Education and Work Experience Requirements:

1. Bachelor’s degree or equivalent work experience – science related field preferred.

2. Minimum 3-5 years pharmaceutical experience, preferably in a Quality role.

3. Must possess knowledge of Good Documentation Practices (GDP).

4. Experience in an aseptic manufacturing and laboratory operations is 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.