Job Details
Title: GMP Clean room Technician
Location: Frederick, MD
Duration: 12 Months on W2
The Cell Therapy Specialist will perform and/or verify all tasks associated with the manufacture of commercial product following batch records and standard operating procedures (SOPs) to ensure safe and compliant operations as well as works as part of a team to execute GMP runs in close collaboration with Materials Management, Quality Control and Quality Assurance.
Responsibilities of the Cell Therapy Specialist include:
Successfully troubleshoots processing and equipment issues while communicating said issues to management
Completes required training assignments to maintain necessary technical skills and knowledge and to ensure compliance with cGMP requirements
Authors and/or revises SOPs that are technically sound, provides clear instructions to align with cGMP requirements and supports efficient operations
Routinely monitors, cleans, prepares and operates sophisticated automated cell processing, cell expansion and filling equipment in Grade B/C clean rooms
o all required PPE and gowning for classified GMP manufacturing areas is provided by the company.
Finds opportunities for improvement in manufacturing efficiencies and compliance while assisting with investigations/deviations and change controls
Basic Requirements:
BA / BS Degree in Sciences Field
OR
AA Degree with 1+ years of cGMP experience
OR
High School Degree and 2+ years of cGMP experience