Packaging QA Lead - Night Shift (Quality & Compliance)

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 1:

Paid Holidays

Paid Time Off

Job summary

Simtra BioPharma Solutions in Bloomington, IN is seeking a Quality Assurance Lead - Packaging to join the QA Leadership Team. You will oversee QA Associates on the Packaging line and ensure products meet specifications on the production floor.

This role requires a science degree or equivalent experience, leadership skills, and a strong grasp of FDA/GxP regulations, with hands-on oversight of inspections, labeling, and change control.

Qualifications

• Bachelor’s degree (preferred science discipline) with 2 years of Pharmaceutical Quality/Manufacturing or other GXP experience, or Associate’s with 3 years, or no degree with 5 years experience.
• Minimum of 2 years in a leadership role.
• Knowledge of inspection/labeling/packaging equipment and processes is preferred.
• Good interpersonal communication skills and strong regulatory knowledge (FDA/GxP).
• Strong technical writing skills and proficiency with MS Office and enterprise software.

Responsibilities

• Lead QA Inspectors for required quality inspections and label control.
• Interview, hire, coach, and develop staff; conduct performance reviews.
• Manage change control activities and deviation investigations.
• Oversee adherence to Quality Systems, audits, validations, and inspections.
• Collaborate with Production, Engineering, and Maintenance to resolve issues.

Skills

Leadership

Team leadership

Regulatory understanding

Problem solving

Communication

Technical writing

Attention to detail

Quality mindset

Education

BSc in science preferred

Associate degree

No degree acceptable with 5+ years experience

Tools

D365

Veeva

ROBAR

Microsoft Word

Microsoft Excel

Microsoft Outlook

Job description

Simtra BioPharma Solutions in Bloomington, IN is seeking a Quality Assurance Lead - Packaging to join the QA Leadership Team. You will oversee QA Associates on the Packaging line and ensure products meet specifications on the production floor.

This role requires a science degree or equivalent experience, leadership skills, and a strong grasp of FDA/GxP regulations, with hands-on oversight of inspections, labeling, and change control.