Quality Assurance Leader – GMP Pharma

Simtra BioPharma Solutions; Bloomington (IN); On-site; USD 90,000 - 130,000; Full time

Benefits offered by this job

Medical & Dental

Flexible Spending Accounts

Life and AD&D Insurance

401(k) with Company Match

Paid Holidays

Paid Time Off

Parental Leave

Adoption Reimbursement

Education Assistance

Employee Assistance Program

Community & Volunteer Program

Employee Ownership Plan

Disability Insurance

Vision Coverage

Identity Theft Protection

Legal Benefits

Onsite Amenities: Workout Facility

Onsite Amenities: Cafeteria

Onsite Amenities: Credit Union

Job summary

Simtra BioPharma Solutions is seeking a Quality Supervisor to join the Quality Assurance Leadership Team in Bloomington, IN. You will supervise QALO personnel, provide oversight for Environmental Monitoring and Manufacturing, and drive compliance with regulatory requirements while supporting continuous improvement on the production floor.

You will communicate effectively with cross-functional teams, prepare for audits, and lead process improvement initiatives.

Qualifications

• Bachelor’s degree (preferred science discipline) and 2 years of Pharmaceutical Quality/Manufacturing or other GXP experience, or Associate’s degree with 3 years, or no degree with 5 years of experience.
• Minimum of 2 years of leadership experience.
• Working knowledge of FDA CFR 210,211 and GDP.
• Experience with environmental monitoring preferred.
• Familiarity with isolator filling machines highly preferred.
• Knowledge of aseptic manufacturing processes required.
• Proficiency in Microsoft Word, Excel, and Outlook; ability to use enterprise software (D365, Blue Mountain, Veeva, etc.).
• Strong technical, analytical, and problem-solving skills.

Responsibilities

• Oversee EM, QALO, and Manufacturing areas to ensure product quality.
• Lead and develop QALO and QA personnel and manage performance.
• Collaborate with manufacturing for rapid, quality-first decision making.
• Ensure training and compliance of QA staff.
• Author and approve investigations, deviations, and SOPs.
• Maintain audit-ready status and regulatory understanding across the site.

Skills

Leadership

Regulatory knowledge

GDP knowledge

Environmental monitoring

Aseptic manufacturing

Problem-solving

FDA CFR 210/211

Isolator filling familiarity

Team collaboration

Education

Bachelor's degree in science

Associate's degree + 3 years experience

No degree + 5 years experience

Tools

Microsoft Word

Excel

Outlook

D365

Blue Mountain

Veeva

Job description

Simtra BioPharma Solutions is seeking a Quality Supervisor to join the Quality Assurance Leadership Team in Bloomington, IN. You will supervise QALO personnel, provide oversight for Environmental Monitoring and Manufacturing, and drive compliance with regulatory requirements while supporting continuous improvement on the production floor.

You will communicate effectively with cross-functional teams, prepare for audits, and lead process improvement initiatives.