Sr. GMP Technician

Senior GMP Technician
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.

Requirements

• 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.

Physical Requirements

• Physically capable of donning and wearing cleanroom/protective gowning and equipment, including but not limited to gowning, goggles, face shields, and protective gloves. PPE is essential for the health and safety of employees
• 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

As part of our promise to talent, Kelly supports those who work with us through a variety of benefits, perks, and work-related resources. Kelly offers eligible employees voluntary benefit plans including medical, dental, vision, telemedicine, term life, whole life, accident insurance, critical illness, a legal plan, and short-term disability.

As a Kelly employee, you will have access to a retirement savings plan, service bonus and holiday pay plans (earn up to eight paid holidays per benefit year), and a transit spending account. In addition, employees are entitled to earn paid sick leave under the applicable state or local plan.

Click here for more information on benefits and perks that may be available to you as a member of the Kelly Talent Community.