Deviation Investigator, GMP & CAPA Champion

TechDigital Group; Bothell (WA); On-site; USD 80,000 - 110,000; Full time

Job summary

An established industry player is seeking a Deviation Investigator to join their Manufacturing Sciences and Technology team. This pivotal role involves overseeing deviation records and ensuring compliance with regulatory standards. The ideal candidate will have a strong background in GMP compliance and FDA/EMA regulations, along with excellent communication and analytical skills. You will collaborate cross-functionally to investigate deviations, implement corrective actions, and drive continuous improvement initiatives. If you are passionate about quality and have a proactive approach to problem-solving, this opportunity is perfect for you to make a significant impact in a dynamic environment.

Qualifications

• 5+ years of cGMP experience in biotech or cellular therapy preferred.
• 2+ years managing deviation and CAPA records required.

Responsibilities

• Manage deviations to achieve right first time and on-time phase completion.
• Lead investigations and facilitate CAPA definition and implementation.

Skills

GMP compliance

FDA/EMA regulations

Communication skills

Cross-functional collaboration

Root cause analysis

Attention to detail

Education

Bachelor's degree in Science or Engineering

Tools

Electronic quality record management system

Job description

An established industry player is seeking a Deviation Investigator to join their Manufacturing Sciences and Technology team. This pivotal role involves overseeing deviation records and ensuring compliance with regulatory standards. The ideal candidate will have a strong background in GMP compliance and FDA/EMA regulations, along with excellent communication and analytical skills. You will collaborate cross-functionally to investigate deviations, implement corrective actions, and drive continuous improvement initiatives. If you are passionate about quality and have a proactive approach to problem-solving, this opportunity is perfect for you to make a significant impact in a dynamic environment.