Sr. GMP Technician

Job detailsKelly 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 position is onsite. 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.Senior GMP TechnicianGeneral RequirementsFollowing local proceduresCompleting required trainingAdhering to GMP requirements for documentation of activitiesCleaning, sanitizing, and breaking down equipmentOperating GMP manufacturing/cleaning equipmentEducationHigh School DiplomaCertifications: Not required, but a certification in pharm processing would be beneficialExperience2-4 years' experience in a GMP facilityResponsibilitiesPrepare 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 equipmentDisassembly and reassembly of equipment per procedure (as required)Perform cleaning activities on the isolators and filling linePerform cleaning verification activities to support cleaning validationAccurately 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 upkeepAuthor and revise SOPs and logbooks.Reviews logbooks at the end of the shift to ensure proper GDP.RequirementsGood 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 RequirementsPhysically 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 employeesPerform operations within ISO Class clean roomsEmployees must be able to lift and/or move up to 40 poundsMust be able to squat, bend, kneel, and or reach for 40% of a shiftMust be able to stand, walk, and/or move about for 40% of a shift