Quality Assurance Lead – EM/QALO On-the-Floor

Simtra US LLC; Bloomington (IN); On-site; USD 85,000 - 110,000; Full time

Benefits offered by this job

Day One Benefits

Medical & Dental Coverage

401(k) Retirement Savings Plan with 1:

Job summary

Simtra BioPharma Solutions in Bloomington, IN, is seeking a Quality Supervisor to join the QA Leadership Team. You will supervise QALO personnel, support Environmental Monitoring and Manufacturing, ensure regulatory compliance and implement Simtra SOPs on the production floor.

This role requires 2+ years of leadership in pharma/GXP, knowledge of FDA CFR 210,211, GDP, aseptic processes, and strong communication. First shift is Mon-Thu 6a-4:30p, with opportunities to drive continuous improvement.

Qualifications

• Bachelor's degree in science preferred with 2+ years of pharma/GxP experience.
• Leadership experience required.
• Knowledge of FDA CFR 210/211 and GDP.
• Environmental monitoring experience is a plus.
• Aseptic manufacturing knowledge is required.

Responsibilities

• Supervise EM and QALO personnel.
• Grow, manage, develop and evaluate personnel including hiring and performance reviews.
• Provide rapid, quality-first decision-making in collaboration with manufacturing and cross-functional teams.
• Ensure training and compliance of QALO associates and Quality Technicians.
• Author and approves investigation/deviation reports.
• Lead ongoing QALO and environmental monitoring activities and assist cross-functional areas to ensure successful execution.

Skills

Leadership

Regulatory knowledge

Environmental monitoring

GDP familiarity

Aseptic manufacturing

Analytical problem solving

MS Office / Enterprise software

Education

Bachelor's degree in Science (preferred)

Associate degree with 3+ years experience

No degree with 5+ years experience

Tools

D365

Blue Mountain

Veeva

Microsoft Office

Job description

Simtra BioPharma Solutions in Bloomington, IN, is seeking a Quality Supervisor to join the QA Leadership Team. You will supervise QALO personnel, support Environmental Monitoring and Manufacturing, ensure regulatory compliance and implement Simtra SOPs on the production floor.

This role requires 2+ years of leadership in pharma/GXP, knowledge of FDA CFR 210,211, GDP, aseptic processes, and strong communication. First shift is Mon-Thu 6a-4:30p, with opportunities to drive continuous improvement.