Quality Assurance Supervisor - GMP Manufacturing Lead

Simtra US LLC; Bloomington (IN); On-site; USD 85,000 - 115,000; Full time

Benefits offered by this job

Medical & Dental Coverage

401(k) Retirement Plan with match

Flexible Spending Accounts

Job summary

Simtra BioPharma Solutions in Bloomington, IN is seeking a Quality Supervisor to join the Quality Assurance Leadership Team. You will support Environmental Monitoring, QALO and Manufacturing to ensure finished products meet specifications, supervising QALO staff and guiding quality oversight on the production floor.

This role emphasizes decision-making, regulatory compliance, and collaboration with cross-functional teams. Weekend AM hours are Friday, Saturday, and Sunday 7a-7:30p.

Qualifications

• Bachelor's degree (preferred) in science or related field.
• 2 years in Pharmaceutical Quality/Manufacturing or other GXP, or 3 years with Associate degree.
• Leadership experience: minimum 2 years.
• Knowledge of FDA CFR 210,211 and GDP.
• Experience with environmental monitoring preferred.
• Familiarity with isolator filling machines preferred.
• Knowledge of aseptic manufacturing processes.
• Strong interpersonal/communication/influencing skills.
• Proficient with MS Word/Excel/Outlook and enterprise software (e.g., D365, Veeva).
• Strong technical, analytical and problem-solving skills.

Responsibilities

• Perform primary EM and QALO responsibilities.
• Grow, manage and evaluate personnel including hiring.
• Provide rapid, quality-first decision-making with cross-functional teams.
• Ensure training and compliance of QALO associates and Technicians.
• Author and approve investigations and deviation reports.
• Lead daily QALO and environmental monitoring activities.
• Ensure tasks meet Quality and site metrics.
• Write, revise and review SOPs, batch records and docs.
• Ensure compliance with regulations and safety requirements.
• Lead process improvements, TE/DOE projects and data analysis.
• Lead audit readiness efforts and regulatory compliance.

Skills

Leadership

Quality assurance

Regulatory knowledge

Problem solving

Communication

GMP knowledge

Environmental monitoring

Aseptic manufacturing

Auditing

Training & development

Education

Bachelor's degree (preferred science)

Associate's degree

Tools

Excel

Outlook

D365

Veeva

Blue Mountain

Job description

Simtra BioPharma Solutions in Bloomington, IN is seeking a Quality Supervisor to join the Quality Assurance Leadership Team. You will support Environmental Monitoring, QALO and Manufacturing to ensure finished products meet specifications, supervising QALO staff and guiding quality oversight on the production floor.

This role emphasizes decision-making, regulatory compliance, and collaboration with cross-functional teams. Weekend AM hours are Friday, Saturday, and Sunday 7a-7:30p.