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Kelly Science, Engineering, Technology & Telecom · 1 day ago

Senior GMP Technician

Rahway, NJ

Full-time

Onsite

Senior Level

Kelly Science, Engineering, Technology & Telecom is seeking a Senior GMP Technician. The role involves preparing disinfectants, cleaning processing rooms, and maintaining materials inventory while ensuring compliance with GMP regulations and documentation standards.

Staffing & Recruiting

Hiring Manager

Kellie Pharr

Responsibilities

Prepare the appropriate disinfectants as per SOP

Understand the dwell time for all cleaning agents/chemicals

Cleaning of the processing rooms following manufacturing processes and as required per procedure. Remove all trash/biohazard waste bags from the MFG area

Stocks all gowning materials in all air locks and locker rooms

Execute cleaning of major and minor pieces of equipment and ancillary equipment

Disassembly and reassembly of equipment per procedure (as required)

Perform cleaning activities on the isolators and filling line

Perform cleaning verification activities to support cleaning validation

Accurately documenting activities in the appropriate logbooks

Able to work with a respirator during special assignments, if required

Maintain materials inventory

Report any unexpected observations to area management

Perform tasks under minimal supervision, and within tight timelines to meet production schedule

Coordinate with engineers & maintenance personnel in facility upkeep

Author and revise SOPs and logbooks

Reviews logbooks at the end of the shift to ensure proper GDP

Qualification

GMP regulationsCleaning validationInterpersonal skillsAttention to detailTeamwork

Required

Good interpersonal skills and attention to detail

Previous experience in cleaning the GMP area is required

Must be able to follow GMP regulations during operations, including adherence to written procedure and contemporaneous documentation

Must be able to record data accurately and legibly

Ability to perform in a team setting in a controlled environment for long periods of time

Physically capable of donning and wearing cleanroom/protective gowning and equipment, including but not limited to gowning, goggles, face shields, and protective gloves

Perform operations within ISO Class clean rooms

Employees must be able to lift and/or move up to 40 pounds

Must be able to squat, bend, kneel, and or reach for 40% of a shift