Sr GMP Technician
Rahway, New Jersey
Kelly Science and Clinical FSP is currently seeking a Sr GMP Technician for a long-term engagement in Rahway, NJ with one of our Global Pharmaceutical clients. This person will join our Kelly FSP (Functional Service Provider) division, a managed solution provider and business unit of Kelly Services, Inc. This role is full-time and is offering full benefit options. As a Kelly FSP employee you may be eligible for Medical, Dental, Vision, 401K and a variety of other benefits to choose from. You may also be eligible for paid time off, including holiday, vacation, and sick/personal time.
- Following local procedures
- Completing required trainings
- Adhering to GMP requirements for documentation of activities
- Cleaning, sanitizing, and breaking down equipment
- Operating GMP manufacturing/cleaning equipment
High School Diploma
Not required but a certification in pharm processing would be beneficial
2-4 years’ experience in a GMP facility
- 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.
- Good interpersonal skills and attention to detail.
- Previous experience in cleaning 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 to don and wear cleanroom/protective gowning and equipment, including but not limited to gowning, goggles, face shields, and protective gloves. PPE are essential for the health and safety of employees
- Perform operations within ISO Class clean rooms
- Employee 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
Must be able to stand, walk, and/or move about for 40% of a shift