Quality Associate 1 - Operations

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: 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.\tProvide 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.\tPerform and/or oversee quality inspections including, but not limited to: labels, components, filled vials, and packaging. 3.\tAssist with the review of sampling, dispensing, shipping, and receiving material packets for GDP adherence. 4.\tPerform Acceptable Quality Limit (AQL) sampling on products/materials and maintain visual inspection qualification status. 5.\tCollaborate 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.\tPerform status change of material and/or finished product per the validated inventory management system. 7.\tBecome gowning qualified to perform Quality functions within the cleanrooms (line clearances, batch execution support). 8.\tProcess shipments and receipts of controlled substances, maintain qualification status as controlled substance authorized personnel. 9.\tRepresent Quality Assurance at various project and technical meetings, as needed. 10.\tAuthor deviations, CAPAs, and change controls as needed. 11.\tWrite and review Standard Operating Procedures related to Quality systems within Supply Chain Management and Manufacturing. 12.\tPerform 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.\tComply with quality and safety management systems including requirements for documentation, training, system use, SOPs, processes and procedures 14.\tWork 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.\tBachelor’s Degree or equivalent experience- science related field preferred. 2.\tMinimum 1-3 years pharmaceutical experience is desired, preferably in a Quality role. 3.\tExperience with aseptic manufacturing and supply chain operations 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