GMP Support Associate

RoslinCT US•Hopkinton, MA

2d•$20 - $31

About The Position

Reporting to the Supervisor, GMP Support, this role supports and ensures that all cleaning activities are performed consistently, safely, and in alignment with current Good Manufacturing Practices (cGMP) and internal requirements. Responsible for ordering, movement, and inventory of GMP materials (e.g., cleaning, and process related materials). Collaborate with Manufacturing, Supply Chain/Operations, and the Facilities team to ensure timely access to the controlled areas, and materials.

Requirements

0-2 years of experience in a GMP-regulated environment
Proficiency in Microsoft Office Suite (Excel, Word, PowerPoint).
Effective problem-solving capabilities.
Strong oral and written communication skills.
Comfortable in a fast-paced and dynamic environment with minimal direction and able to adjust workload based upon changing priorities

Nice To Haves

Skilled in Microsoft Word, Excel, and commonly used Manufacturing and Quality systems (preferred)

Responsibilities

Responsible for the cleaning operations in classified and non-classified environments (e.g., Grade B-D, CNC)
Ensure all cleaning activities comply with cGMP, SOPs, and regulatory expectations
Orders, moves, and ensures the manufacturing inventory and kitting of GMP materials.
Perform and verify GMP-compliant kitting of materials for use in classified areas
Performs GMP kitting activities, maintaining traceability, status labeling, and the appropriate segregation.
Coordinate with Supply Chain and Warehouse teams to maintain adequate stock levels and avoid shortages
Coordinate timing with cross-functional teams on the availability of the classified areas
Other duties as assigned.