Quality Assurance Lead - Night Shift

Simtra BioPharma Solutions; Bloomington (IN); On-site; USD 90,000 - 120,000; Full time

Benefits offered by this job

Medical & Dental Coverage

401(k) Retirement Savings Plan with 公司

Paid Holidays

Paid Time Off

Job summary

Simtra BioPharma Solutions in Bloomington, IN is seeking a Quality Supervisor to join the Quality Assurance Leadership Team. Reporting to the Quality Manager, you will oversee QALO personnel on the production floor, ensuring finished products meet specifications and regulatory guidelines.

You will collaborate with Manufacturing and cross-functional teams, drive quality improvements, and uphold SISPQ principles, with a schedule of Friday evening to Monday morning shifts and overtime as needed for

Qualifications

• Bachelor’s degree (preferred science discipline) plus 2 years in Pharmaceutical Quality/Manufacturing or 3 years with Associate’s degree.
• Minimum 2 years of leadership experience.
• Working knowledge of FDA CFR 210,211 and GDP; Good Documentation Practices required.
• Knowledge of aseptic manufacturing processes is required.
• Proficiency with MS Word, Excel, Outlook and enterprise software (examples: D365, Blue Mountain, Veeva).

Responsibilities

• Perform the primary responsibilities of QALO personnel.
• Grow, manage, develop and evaluate QALO personnel including hiring.
• Provide rapid, quality-first decision-making with manufacturing and cross-functional teams.
• Ensure training and compliance of QALO associates and Quality Technicians.
• Draft and approve investigation/deviation reports.
• Lead daily QALO activities and assist cross-functional areas.
• Ensure tasks are completed to meet Quality and site metrics.
• Draft, revise and review SOPs, batch records and related documentation.
• Ensure compliance with federal, state, local regulations and safety policies.
• Lead and participate in process/product improvement projects and validations.
• Support audit readiness and stay current with regulatory requirements.

Skills

Leadership

GXP/Regulatory Knowledge

Aseptic manufacturing

Quality oversight

Problem solving

Communication

Education

Bachelor’s degree (preferred science)

Associate’s degree

No degree with 5+ years experience

Tools

D365

Blue Mountain

Veeva

Microsoft Word

Excel

Outlook

Job description

Simtra BioPharma Solutions in Bloomington, IN is seeking a Quality Supervisor to join the Quality Assurance Leadership Team. Reporting to the Quality Manager, you will oversee QALO personnel on the production floor, ensuring finished products meet specifications and regulatory guidelines.

You will collaborate with Manufacturing and cross-functional teams, drive quality improvements, and uphold SISPQ principles, with a schedule of Friday evening to Monday morning shifts and overtime as needed for