GMP Compliance Specialist

Applies GMP/GLP in all areas of responsibility, as appropriate.· Independently engage and collaborate with coworkers, customers, and management within a GMP environment· Work with multiple analytical testing group in a GMP environment to harmonize cGMP operations with the goal of minimizing departures, deviation observations, and deviations· Ensure adherence to highest quality and efficiency standards in laboratory operations· Anticipate quality events or issues and elevate them to the appropriate management immediately· Participate in conducting and assisting with investigations, writing quality events, and putting effective CAPAs in place· Help develop and manage an internal walkthrough system· Conduct walkthroughs of lab spaces to support client and regulatory inspection readiness· Assist with training oversight· Help develop and lead training session for our staff· Help maintain a compliance SharePoint site· The compliance program is under continuous development and additional project and job responsibilities could be added in the future as the program evolves.