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 in Clinical Release & Stability labs.
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.
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-Software experience with Empower SAP Sustain, SAP Meridian Cloud, Trackwise
-Experience with technical writing -- writing protocols and procedures, validation documentation
Benefit packages for this role will start on the 31st day of employment and include medical, dental, and vision insurance, as well as HSA, FSA, and DCFSA account options, and 401k retirement account access with employer matching. Employees in this role are also entitled to paid sick leave and/or other paid time off as provided by applicable law.