Job Description One 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 We are a company committed to creating diverse and inclusive environments where people can bring their full, authentic selves to work every day. We are an equal opportunity/affirmative action employer that believes everyone matters. Qualified candidates will receive consideration for employment regardless of their race, color, ethnicity, religion, sex (including pregnancy), sexual orientation, gender identity and expression, marital status, national origin, ancestry, genetic factors, age, disability, protected veteran status, military or uniformed service member status, or any other status or characteristic protected by applicable laws, regulations, and ordinances. If you need assistance and/or a reasonable accommodation due to a disability during the application or recruiting process, please send a request to HR@insightglobal.com .     To learn more about how we collect, keep, and process your private information, please review Insight Global's Workforce Privacy Policy: https://insightglobal.com/workforce-privacy-policy/ . Skills and Requirements -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 mindset -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 assessment null We are a company committed to creating diverse and inclusive environments where people can bring their full, authentic selves to work every day. We are an equal employment opportunity/affirmative action employer that believes everyone matters. Qualified candidates will receive consideration for employment without regard to race, color, ethnicity, religion,sex (including pregnancy), sexual orientation, gender identity and expression, marital status, national origin, ancestry, genetic factors, age, disability, protected veteran status, military oruniformed service member status, or any other status or characteristic protected by applicable laws, regulations, andordinances. If you need assistance and/or a reasonable accommodation due to a disability during the application or the recruiting process, please send a request to HR@insightglobal.com.