Quality Associate 1 - Operations

Bloomington Bagel Company; Bloomington (IN); On-site; USD 55,000 - 75,000; 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

401(k) with company match

Job summary

Singota Solutions in Bloomington, IN, is seeking a Quality Associate 1 - Operations to provide QA oversight for daily manufacturing and supply chain activities. The role focuses on document accuracy, batch record reviews, and regulatory compliance on the shop floor.

Responsibilities include in-process reviews, inspections of labels and packaging, GDP adherence, and collaboration with suppliers on qualification studies.

Qualifications

• Bachelor’s Degree or equivalent in a science-related field preferred.
• 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 record review, room release, equipment release, logbook and documentation review, and process oversight.
• Perform and/or oversee quality inspections including labels, components, filled vials, and packaging.
• Assist with the review of sampling, dispensing, shipping, and receiving material packets for GDP adherence.
• Perform Acceptable Quality Limit (AQL) sampling on products/materials and maintain visual inspection qualification status.
• Collaborate with applicable suppliers to provide oversight for shipping qualification studies and review supplier protocols.
• Perform status changes of material and/or finished product in the inventory system.
• Become gowning qualified to perform Quality functions within cleanrooms.
• Process shipments and receipts of controlled substances and maintain qualification status.
• Represent Quality Assurance at project and technical meetings.
• Author deviations, CAPAs, and change controls.
• Write and review SOPs related to Quality systems within SCM and Manufacturing.
• Perform other duties as assigned by Quality Manager.
• Comply with quality and safety management systems in documentation, training, SOPs, and procedures.
• Work with other departments to meet business needs.

Education

Bachelor’s Degree or equivalent experience - science related field

Job description

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.

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