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Laboratory Equipment Specialist

4 months ago

Malvern, United States Insight Global Full time

Required Skills and Experience:

-Bachelor degree in Scientific field

-Minimum 2 years of experience working within a QC GMP environment with troubleshooting exposure of equipment

-Excellent GxP understanding

-Technically proficient in understanding GMP instrumentation

-Strong experience utilizing Microsoft Office

-Go-getter personality with team-oriented mindset


Nice to Have Skills and Experience:

-Software experience with Empower SAP Sustain, SAP Meridian Cloud, Trackwise

-Experience with technical writing -- writing protocols and procedures, validation documentation


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 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