GMP Equipment Scientist

HIRING METHOD - 1 Year Long Contract with extension OR possible permanent conversionAmenities - 10 Days of PTO 6 Sick Days Paid Holidays RATE: $36.75hr to $45.97hr.Exact compensation may vary based on several factors, including skills, experience, and education.Healthcare benefit packages for this role will start on the 1st day of employment and include medical, dental, and vision insurance, financial protection benefits, as well as HSA, FSA, and DCFSA account options. 401k retirement account access is offered starting on the 90th day with employer matching after one year of service. Employees in this role are also entitled to paid sick leave andor other paid time off as provided by applicable law.JOB DESCRIPTION-Bachelor degree in Scientific field -Minimum 4 years of experience working within a Quality GMP environment with troubleshooting exposure of equipment - USP, EP and Compendial standards -Minimum 4 years of experience with qualification of GMP instrumentation -Excellent GxP understanding -Strong experience utilizing Microsoft Office -Go-getter personality with team-oriented mindsetNice to Have Skills & Experience-Empower, SAP, Meridian, Kneat system experience -Trackwise or Comet experience -Background with cell counters, flow cytometers, plate readers, PCR machines, DNA sequencing, ddPCR equipment -Experience with technical writing - creating protocols and procedures, validation documentation Experience working with 21 CFR Part 11 assessment or ANNEX 11 assessmentOne of our large pharmaceutical clients is looking to hire an Qualification Analyst for the Equipment Lifecycle Management team within the Quality department. This individual will be responsible for following Quality Control procedures on the installation, qualification, and maintenance of GMP analytical instruments for the Clinical Release and Stability lab in Malvern PA. Responsibilities will include: -Leading and participating in cross-functional teams. -Communicating with vendors to coordinate maintenance and troubleshooting activities. -Must follow Good Documentation practices. -Draft and execute instrument qualification protocols, site operating procedures, and other technical documents with minimal guidance once trained on internal processes. -Draft protocols, supporting documents, and procedures for new instruments and equipment. -Write and execute QC analytical equipment qualifications -Connect with QA to follow up on investigations to understand the root cause -Overall Equipment lifecycle management

Created: 2025-02-21