ELM Qualification Analyst
3 weeks ago
One of our large pharmaceutical clients is seeking to bring on an ELM Qualification Analyst to join their growing 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
Qualifications:
- Bachelor’s Degree in a scientific field
- Minimum 2 years of experience working within a QC GMP environment with troubleshooting exposure of equipment
- Experience with technical writing - writing protocols, procedures, and validation documentation
- Technically proficient in understanding GMP instrumentation
- Go-getter personality with team-oriented mindset
- Experience with Empower, SAP Sustain, SAP Meridian Cloud or Trackwise is a plus
Pay: $40.00-$60.00/hr (flexible based on years of experience)
Hours: Monday-Friday, 9:00am-5:00pm
Hiring Method: Multiyear contract – After 1 year on contract, the individual will have the opportunity to apply for a permanent role or have their contract renewed for another year
PTO: 10 PTO days annually & 6 paid sick days
Benefits: Medical, Dental, Vision and 401K plans available
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.
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Malvern, United States Insight Global Full timeOne of our large pharmaceutical clients is seeking to bring on an ELM Qualification Analyst to join their growing 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...
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