QA Lead, Packaging – Night Shift (Pharma)

Inuplands; Bloomington (IN); Hybrid; USD 90,000 - 120,000; Full time

Benefits offered by this job

Medical & Dental Coverage

401(k) Retirement Savings Plan with 회사

Time Off Program (PTO & Holidays)

Education Assistance Program

Employee Ownership Plan

Onsite Campus Amenities

Job summary

Simtra BioPharma Solutions is seeking a Quality Assurance Lead – Packaging to join the QA Leadership Team in Bloomington. You will supervise QA Associates on nights and provide quality oversight to ensure finished products meet specifications and regulatory requirements.

You will lead inspections, participate in deviations, CAPAs, and change controls, and collaborate with production to ensure on-time, compliant results while maintaining audit readiness and strong cross-functional communication.

Qualifications

• Bachelor’s degree in a science discipline and 2 years in Pharmaceutical Quality/Manufacturing or related GXP field, or equivalent experience.
• Minimum 2 years in a leadership role.
• Knowledge of inspection/labeling/packaging equipment and processes preferred.
• Strong communication and regulatory writing skills.
• Familiarity with FDA regulations and Good Documentation Practices.

Responsibilities

• Lead QA Inspectors and provide guidance for quality inspections and label control.
• Interview, hire, coach, and develop QA staff; conduct performance reviews.
• Plan and schedule QA inspections and related activities to meet quality objectives.
• Drive compliance with regulatory standards and Simtra SOPs.
• Manage change controls, deviations, CAPAs, and related documentation.
• Collaborate with Production, Engineering, and Maintenance to resolve issues on batch processing.
• Support audits, validations, and related quality activities; maintain audit readiness.

Skills

Leadership

FDA Regulations

GXP Knowledge

Quality Systems

Technical Writing

Interpersonal Skills

Problem Solving

Labeling/Packaging Equipment

Education

Bachelor’s degree in science (preferred)

Associate’s degree with 3+ years in pharma/GXP

No degree with 5+ years in pharma/GXP

Tools

Microsoft Word

Excel

Outlook

Job description

Simtra BioPharma Solutions is seeking a Quality Assurance Lead – Packaging to join the QA Leadership Team in Bloomington. You will supervise QA Associates on nights and provide quality oversight to ensure finished products meet specifications and regulatory requirements.

You will lead inspections, participate in deviations, CAPAs, and change controls, and collaborate with production to ensure on-time, compliant results while maintaining audit readiness and strong cross-functional communication.