Equipment Lifecycle Management Analyst

2 days ago


Malvern, United States Insight Global Full time

HIRING MODEL

1 YEAR LONG EXTENDING CONTRACT (10 DAYS OF PTO / 6 SICK DAYS)


Compensation:

$37/hr to $46/hr.

Exact compensation may vary based on several factors, including skills, experience, and education.

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.


Requirements:

-Bachelor degree in Scientific field

-Minimum 2 years of experience working within a Quality GMP environment with troubleshooting exposure of equipment – USP, EP and Compendial standards

-Minimum 2-3 years of experience with qualification of GMP instrumentation

-Excellent GxP understanding

-Strong experience utilizing Microsoft Office

-Go-getter personality with team-oriented mindset

Preferred:

-Empower experience

-Trackwise or Comet experience

-Background with HPLC instrumentation

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

Experience working with 21 CFR Part 11 assessment or ANNEX 11 assessment


Day to Day:

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 5 Quality labs 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


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