Quality Supervisor – Pharma QA Leadership (GMP)

Simtra US LLC; 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 1:

Time Off Program – Holidays & PTO

Paid Parental Leave

Education Assistance Program

Employee Assistance Program

Onsite Campus Amenities

Job summary

Simtra BioPharma Solutions in Bloomington, IN, seeks a Quality Supervisor to lead the Quality Assurance Leadership Team, supervising QALO personnel and ensuring finished products meet specifications. The role interfaces with Manufacturing and cross-functional teams to uphold regulatory standards and Simtra SOPs.

The QALO Associate III role drives compliance, supports continuous improvement, and maintains site metrics while championing SISPQ in manufacturing operations.

Qualifications

• Bachelor's degree in a science discipline and 2 years of pharmaceutical quality/manufacturing or related GXP experience, or an associate's degree with 3+ years, or no degree with 5+ years of experience.
• Familiarity with FDA CFR 210, 211 and GDP.
• Knowledge of aseptic manufacturing processes.

Responsibilities

• Lead QALO activities and ensure quality oversight on the production floor.
• Coach and develop QALO personnel, including hiring and performance reviews.
• Provide rapid, quality-first decision-making with manufacturing and cross-functional teams.
• Ensure training and compliance of QALO associates and Quality Technicians.

Skills

Leadership

Regulatory knowledge

Problem-solving

Communication

Interpersonal skills

Education

Bachelor's degree in science field

2+ years in Pharmaceutical Quality/Manufacturing or GXP

Tools

Microsoft Word

Excel

Outlook

D365

Blue Mountain

Veeva

Job description

Simtra BioPharma Solutions in Bloomington, IN, seeks a Quality Supervisor to lead the Quality Assurance Leadership Team, supervising QALO personnel and ensuring finished products meet specifications. The role interfaces with Manufacturing and cross-functional teams to uphold regulatory standards and Simtra SOPs.

The QALO Associate III role drives compliance, supports continuous improvement, and maintains site metrics while championing SISPQ in manufacturing operations.