Quality Assurance Lead, Packaging – 3rd Shift

Socket.dev; Bloomington (IN); On-site; USD 95,000 - 125,000; Full time

Benefits offered by this job

Day One Benefits

Medical & Dental Coverage

401(k) with Company Match

Paid Holidays & PTO

Education Assistance Program

Job summary

Simtra BioPharma Solutions in Bloomington, IN seeks a QA Lead for Packaging to join the Quality Assurance Leadership Team. This role directs 3rd shift QA associates and manufacturing packaging to ensure finished products meet specs.

You will lead QA inspectors, enforce regulatory standards, and drive improvements on the production floor. Responsibilities include scheduling inspections, coaching staff, audits readiness, and collaboration with production, engineering, and maintenance to resolve

Qualifications

• Bachelor’s degree (preferred science) with 2+ years in QA/Manufacturing or related GXP field.
• 2+ years in a leadership role is required.
• Knowledge of inspection/labeling/packaging equipment and processes is preferred.
• Strong written and verbal communication; FDA/GMP fundamentals expected.
• Proficiency with Microsoft Office and enterprise software used in QA.

Responsibilities

• Lead QA Inspectors and supervise packaging quality oversight.
• Ensure compliance with regulatory standards and Simtra SOPs.
• Plan and schedule QA inspections and label control activities.
• Coach and develop staff; conduct performance reviews and objectives.
• Drive quality objectives and audit readiness for the department.
• Participate in process improvements, validations, and data reporting.
• Coordinate change control, deviation handling, CAPAs, and related docs.
• Collaborate with Production, Engineering, and Maintenance to resolve issues.

Skills

Leadership

Interpersonal communication

FDA Regulations knowledge

GXP compliance

Technical writing

Problem solving

MS Word/Excel/Outlook

Enterprise software (D365, Veeva, ROBi

Education

Bachelor’s degree in science

Associate’s degree with 3+ years in QA/Manufacturing

No degree with 5+ years in QA/Manufacturing

Tools

D365

Veeva

ROBAS

Job description

Simtra BioPharma Solutions in Bloomington, IN seeks a QA Lead for Packaging to join the Quality Assurance Leadership Team. This role directs 3rd shift QA associates and manufacturing packaging to ensure finished products meet specs.

You will lead QA inspectors, enforce regulatory standards, and drive improvements on the production floor. Responsibilities include scheduling inspections, coaching staff, audits readiness, and collaboration with production, engineering, and maintenance to resolve