Quality Assurance Associate, Pharmaceutical Ops

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

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.