Sr. GMP Technician

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 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 Technician*
* ** General Requirements*
* + Following local procedures

+ Completing required training

+ Adhering to GMP requirements for documentation of activities

+ Cleaning, sanitizing, and breaking down equipment

+ Operating GMP manufacturing/cleaning equipment

** Education*
* + High School Diploma

+

Certifications:

Not required, but a certification in pharm processing would be beneficial

** Experience*
* + 2-4 years' experience in a GMP facility

** 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

+ Must be able to stand, walk, and/or move about 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.  ()  for more information on benefits and perks that may be available to you as a member of the Kelly Talent Community.

Why Kelly ®  Science & Clinical?

Kelly Science & Clinical is your connection to premier scientific and clinical companies looking to hire industry experts just like you. Our team creates expert talent solutions to solve the world's most critical challenges. Every day, we match science professionals with dream jobs that fit their skills, interests, and career goals-it's the way we think job searching should be. Nearly 100 percent of our science recruiters have a professional background and education in science, so we know a thing or two about the science market and how to get your expertise noticed.

About Kelly

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