Quality Auditor

About the role

The Quality Auditor ensures that in‑process and finished pharmaceutical products meet customer specifications and regulatory requirements. This position provides comprehensive manufacturing quality inspection services, including sampling, testing, documentation, and traceability, while supporting a Lean environment.

Key responsibilities

• Perform sampling, visual inspections, and testing of in‑process and finished goods using calibrated equipment such as laser micrometers and optical comparators.
• Release acceptable products for further processing or shipping and segregate non‑conforming items.
• Review inspection records to confirm compliance with specifications and proper documentation practices.
• Retain product samples, maintain batch records, and manage document disposition (filing, scanning, etc.).
• Generate rejection, deviation, and trace‑back investigation reports as directed.
• Print and manage quality system documents from Master Control, ShopFloor, or related software.
• Promote and support Lean initiatives and adhere to all corporate, site‑specific, and safety regulations.

Required profile

• High school diploma or GED required; associate degree in science, math, or related field preferred.
• 1+ year of experience in a cGMP environment or related field preferred.
• Reliable, punctual attendance and ability to work a 12‑hour shift rotation (2,2,3).
• Ability to read, write, and speak English.

Required skills

• Proficiency with calibrated test equipment (laser micrometer, optical comparator).
• Knowledge of ANSI, AQL, and ShopFloor systems.
• Basic computer skills and experience with document control software (Master Control, ShopFloor).
• Understanding of ISO standards and Good Documentation Practices (GDP).

What we offer

• Generous paid time off with flexible vacation, personal, and holiday leave.
• Performance‑based bonuses, service recognition, and employee appreciation programs.
• Inclusive, collaborative culture that values diversity, equity, and inclusion.
• Continuous learning opportunities, tuition assistance, and leadership development.
• Global career opportunities across North America, Europe, and Asia‑Pacific.
• Community involvement through volunteer programs and charitable initiatives.