Quality Associate, GMP Operations & Compliance

Singota Solutions; Bloomington (IN); Hybrid; 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

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.