Quality Assurance Leader - GMP Operations

simtrabps; Bloomington (IN); On-site; USD 90,000 - 120,000; Full time

Job summary

Simtra BioPharma Solutions in Bloomington, Indiana, is seeking a Quality Supervisor to join the QA Leadership Team. They provide direct support to Quality Operations and Manufacturing to ensure finished products meet required specifications by supervising QALO personnel and ensuring regulatory compliance.

This role drives training, investigations, document control, and continuous improvement initiatives within a GMP environment, coordinating with cross-functional teams to maintain high-quality

Qualifications

• Bachelor's degree in a science field with 2 years in pharma quality/GXP
• Alternative: Associate's degree with ≥3 years in pharma quality/GXP
• No degree with ≥5 years in pharma quality/GXP
• Minimum of 2 years of leadership experience
• Knowledge of FDA CFR 210,211 and GDP
• Knowledge of aseptic manufacturing processes
• Strong interpersonal/communication/influencing skills
• Computer proficiency in Word, Excel, and Outlook

Responsibilities

• Able to perform all primary responsibilities of QALO personnel
• Grow, manage, develop and evaluate QALO personnel
• Provides rapid, quality-first decision-making with cross-functional teams
• Ensures training and compliance of QALO staff
• Authors and reviews investigation/deviation reports
• Leads ongoing daily QALO activities and assists cross-functional areas
• Ensures tasks are completed to meet quality and site metrics
• Authors, revise and review SOPs, batch records and related docs
• Ensure compliance with regulations and safety
• Participate in process/product improvement projects and audits

Skills

Leadership experience

Regulatory knowledge

Communication skills

GXP/GDP knowledge

Aseptic manufacturing knowledge

Education

Bachelor's degree in science

Associate's degree in science

Tools

Microsoft Word

Microsoft Excel

Outlook

Job description

Simtra BioPharma Solutions in Bloomington, Indiana, is seeking a Quality Supervisor to join the QA Leadership Team. They provide direct support to Quality Operations and Manufacturing to ensure finished products meet required specifications by supervising QALO personnel and ensuring regulatory compliance.

This role drives training, investigations, document control, and continuous improvement initiatives within a GMP environment, coordinating with cross-functional teams to maintain high-quality