QA Lead - Packaging (Night Shift)

Simtra BioPharma Solutions; Bloomington (IN); Presencial; USD 85.000 - 120.000; Jornada completa

Ventajas ofrecidas por este puesto de trabajo

Medical & Dental Coverage

401(k) Matching

Time Off Program

Descripción de la vacante

Simtra BioPharma Solutions in Bloomington, Indiana, is seeking a QA Lead – Packaging to join the Quality Assurance Leadership Team. This role provides oversight for QA Associates on the 3rd shift and ensures finished products meet specifications, with direct support to packaging operations.

The position requires a Bachelor’s in a science field (or equivalent experience), 2+ years in leadership, and strong documentation and GMP knowledge. On-site role with comprehensive benefits.

Formación

• Pharmaceutical quality/manufacturing experience with GXP knowledge.
• Experience in a leadership role and staff development.
• Strong written and verbal communication and problem-solving abilities.
• Familiarity with FDA regulations and quality systems.
• Proficiency in Microsoft Office and enterprise software.

Responsabilidades

• Lead QA Inspectors and ensure quality inspections and label control.
• Act as SME on QA procedures for Inspection and Packaging.
• Plan and schedule QA work with production teams.
• Hire, coach and evaluate staff and set development plans.
• Drive quality objectives and timely delivery aligned with site goals.
• Support change controls, validations, deviations, CAPAs, and data trends.
• Collaborate with production, engineering, and maintenance to resolve issues.

Educación

Bachelor’s degree (preferred science discipline)

Associate’s degree with 3+ years of Pharmaceutical Quality/Manufacturing or other GXP regulated experience

5+ years Pharmaceutical Quality/Manufacturing or other GXP experience (no degree)

2+ years in a leadership role

Strong interpersonal communication skills

Good and technical writing skills

Working knowledge of FDA Regulations and GMP

Computer proficiency: Word, Excel, Outlook; enterprise software (D365, Veeva, ROBAR)

Herramientas

D365

Veeva

ROBAR

Descripción del empleo

Simtra BioPharma Solutions in Bloomington, Indiana, is seeking a QA Lead – Packaging to join the Quality Assurance Leadership Team. This role provides oversight for QA Associates on the 3rd shift and ensures finished products meet specifications, with direct support to packaging operations.

The position requires a Bachelor’s in a science field (or equivalent experience), 2+ years in leadership, and strong documentation and GMP knowledge. On-site role with comprehensive benefits.