Quality Supervisor, QA Line Ops — Weekend AM Shift

Simtra-Biopharma-Solutions; Bloomington (IN); On-site; USD 85,000 - 110,000; Full time

Benefits offered by this job

Medical & Dental Coverage

401(k) Retirement Savings Plan with 회사

Paid Holidays

Paid Time Off

Parental Leave

Education Assistance

Employee Assistance Program

Onsite Campus Amenities

Job summary

Simtra BioPharma Solutions in Bloomington, Indiana seeks a Quality Associate III (Quality Supervisor) to lead QA line operations on the production floor and ensure finished products meet specifications through supervision and cross-functional collaboration.

This role supports the Weekend AM Shift and leads ongoing quality oversight, training, and documentation efforts while ensuring compliance with FDA CFR 210/211, GDP, and Baxter quality standards.

Qualifications

• Degree or related experience in a regulated industry with quality focus.
• Leadership experience in a GMP environment is required.
• Strong knowledge of FDA CFR 210, 211 and GDP practices.
• Aseptic manufacturing understanding is required.

Responsibilities

• Provide quality oversight and chart review for QALO personnel.
• Grow and develop QALO staff including performance evaluation.
• Make rapid, quality-first decisions with manufacturing teams.
• Ensure training and compliance of QALO associates.
• Author investigation/deviation reports and CAPAs as needed.
• Lead daily QALO activities and cross-functional support.
• Draft and review SOPs, batch records, and related docs.
• Maintain compliance with all regulations and safety rules.
• Participate in process/product improvement and audits.

Skills

Leadership

Regulatory knowledge

Quality oversight

Problem solving

GxP experience

Aseptic processing

Education

Bachelor's degree (preferred science)

Associate's degree + 3+ years

No degree + 5+ years experience

Tools

Microsoft Word

Microsoft Excel

Microsoft Outlook

SAP

Veeva

TrackWise

Job description

Simtra BioPharma Solutions in Bloomington, Indiana seeks a Quality Associate III (Quality Supervisor) to lead QA line operations on the production floor and ensure finished products meet specifications through supervision and cross-functional collaboration.

This role supports the Weekend AM Shift and leads ongoing quality oversight, training, and documentation efforts while ensuring compliance with FDA CFR 210/211, GDP, and Baxter quality standards.