Packaging Quality Assurance Lead — 3rd Shift

Simtrabps; Bloomington (IN); On-site; USD 90,000 - 130,000; Full time

Benefits offered by this job

Day One Benefits

Medical & Dental Coverage

401(k) Retirement Savings Plan with Co

Education Assistance Program

Employee Assistance Program

Job summary

Simtra BioPharma Solutions in Bloomington, IN, is seeking a Quality Assurance Lead – Packaging to join the QA Leadership Team. You will supervise QA Associates on the Packaging line, ensuring finished products meet specifications and comply with FDA, GMP, and Simtra SOPs on the production floor.

This role requires strong leadership, solid regulatory knowledge, and the ability to coordinate with Production, Engineering and Maintenance to resolve issues, approve deviations and CAPAs, support

Qualifications

• Bachelor’s degree (preferred science) with 2 years Pharmaceutical Quality/Manufacturing or 3 years with Associate OR equivalent experience
• Minimum of 2 years in a leadership role
• Knowledge of inspection/labeling/packaging equipment and processes is preferred
• Strong technical writing skills and communication abilities
• Working knowledge of FDA Regulations, GMP and Good Documentation Practices

Responsibilities

• Lead QA Inspectors and provide QA oversight on Packaging operations
• Ensure compliance with regulatory standards and Simtra SOPs on the production floor
• Plan and schedule QA inspections and label control
• Hire, coach, and develop staff; conduct performance reviews
• Meet quality objectives efficiently, accurately, and timely
• Participate in process/product improvement projects and validations
• Maintain audit-ready state for Inspection and Packaging complex
• Approve deviations, CAPAs, and related documentation
• Manage change controls and data trends reporting
• Collaborate with Production, Engineering and Maintenance to resolve issues

Skills

Leadership

FDA Regulations

GXP Knowledge

Quality Systems

Problem Solving

Communication Skills

Education

Bachelor's degree in Science

Two years QA in pharma

Associate's degree with 3+ years

Tools

D365

Veeva

ROBAR

Job description

Simtra BioPharma Solutions in Bloomington, IN, is seeking a Quality Assurance Lead – Packaging to join the QA Leadership Team. You will supervise QA Associates on the Packaging line, ensuring finished products meet specifications and comply with FDA, GMP, and Simtra SOPs on the production floor.

This role requires strong leadership, solid regulatory knowledge, and the ability to coordinate with Production, Engineering and Maintenance to resolve issues, approve deviations and CAPAs, support