QA Operations Specialist - cGMP & Validation

Hong Kong Study Skills Research Institute; Holly Springs (NC); Sur place; USD 70 000 - 90 000; Plein temps

Résumé du poste

The Hong Kong Study Skills Research Institute is seeking a QA Specialist, Operations in Holly Springs, NC. This role involves providing QA oversight for Drug Substance Manufacturing processes, ensuring compliance with cGMP regulations and facilitating operational efficiency through various QA tasks.

The ideal candidate will have a BS/BA in Life Sciences or Engineering, 2+ years in a GMP environment, and knowledge of validation software. This position requires working 12-hour shifts in a regulated setting.

Qualifications

• 2+ years of relevant experience or a Master's with 0 years.
• 1–3 years’ experience in a GMP environment.
• Experience in Validation and Quality oversight in FDA-regulated facilities.

Responsabilités

• Provides QA oversight and supports DSM operations.
• Reviews Batch Records and implements immediate responses to deviations.
• Contributes to the development of QA documentation and processes.

Connaissances

GMP Quality Assurance

Validation

Attention to detail

Communication

Formation

BS/BA in Life Sciences or Engineering

Masters in Life Sciences or Engineering

Outils

Smartsheet

Trackwise

MasterControl

Kneat validation software

Description du poste

The Hong Kong Study Skills Research Institute is seeking a QA Specialist, Operations in Holly Springs, NC. This role involves providing QA oversight for Drug Substance Manufacturing processes, ensuring compliance with cGMP regulations and facilitating operational efficiency through various QA tasks.

The ideal candidate will have a BS/BA in Life Sciences or Engineering, 2+ years in a GMP environment, and knowledge of validation software. This position requires working 12-hour shifts in a regulated setting.