Quality Assurance Leader – Night Shift (GXP)

Simtra US LLC; Bloomington (IN); On-site; USD 85,000 - 120,000; Full time

Benefits offered by this job

Day One Benefits

Medical & Dental Coverage

401(k) with Company Match

Paid Holidays

Job summary

Simtra BioPharma Solutions (Simtra) is seeking a Quality Supervisor to join the Quality Assurance Leadership Team in Bloomington, IN. This role oversees QALO personnel, ensuring finished products meet specifications and regulatory standards, while driving quality on the production floor.

The position reports to the Quality Manager and collaborates with Manufacturing and cross-functional teams to uphold SISPQ principles and continuous improvement initiatives.

Qualifications

• Bachelor's degree in a science discipline and 2 years in Pharma QA/manufacturing or 3 years with Associate's degree or 5 years with no degree.
• Minimum 2 years of leadership experience.
• Working knowledge of FDA CFR 210,211 and GDP.
• Knowledge of aseptic manufacturing processes.
• Strong communication and interpersonal skills.

Responsibilities

• Supervise QALO personnel to ensure quality on the production floor.
• Lead training and performance evaluations for QALO staff.
• Provide rapid, quality-first decision-making with cross-functional teams.
• Ensure training/compliance of QALO associates and Quality Technicians.
• Author and approve investigation/deviation reports.
• Lead ongoing QALO activities and assist cross-functional areas.
• Ensure tasks are completed to meet quality/site metrics.
• Draft/revise SOPs, batch records and documentation as needed.
• Maintain compliance with regulations and safety.

Skills

Leadership experience

Regulatory knowledge

Quality assurance

Communication skills

Problem-solving

Education

Bachelor's degree in science

Associate's degree

No degree with experience

Tools

D365

Blue Mountain

Veeva

MS Office Suite

Job description

Simtra BioPharma Solutions (Simtra) is seeking a Quality Supervisor to join the Quality Assurance Leadership Team in Bloomington, IN. This role oversees QALO personnel, ensuring finished products meet specifications and regulatory standards, while driving quality on the production floor.

The position reports to the Quality Manager and collaborates with Manufacturing and cross-functional teams to uphold SISPQ principles and continuous improvement initiatives.