Specialist I, Quality Assurance

The Specialist I, Quality Assurance is an integral entry-level role focused on supporting the effective implementation of our quality policies and systems. In this position, you will assist in the management and documentation of quality processes—including deviations, change controls, CAPAs, and document control—and contribute to batch disposition support to ensure products meet our stringent quality standards. Your work directly aids in maintaining regulatory compliance and enhancing our operational excellence, while also providing a foundation for professional growth within a dynamic, fast-paced environment.

Physical Demands & Work Conditions

• Production Associates: Must have visual acuity of 20/20 (corrected or uncorrected) and normal color vision to safely perform critical tasks such as visual inspection of materials, equipment, and labeling, including distinguishing color-coded components in a GMP environment.
• Must meet cleanroom gowning requirements, including wearing full gowning (face coverings, gloves, hoods, goggles) for up to 3 consecutive hours at a time, minimal movement in the cleanroom, and working with or around human blood, blood-derived materials, cells, other biological materials, and alcohol-based sprays. Use of cosmetics (makeup, painted nails), jewelry, or facial piercings is not permitted in the cleanroom, and any skin conditions that cause shedding must be disclosed.