QC Instrument Lifecycle Specialist II — Elevate Lab Compliance

Aequor

Swiftwater (Monroe County)

On-site

USD 85,000 - 110,000

Full time

40 hours ago
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Job summary

Aequor seeks a Quality Control Instrument Support Specialist II to support lifecycle management of QC instrumentation at the Swiftwater, PA site. You will ensure instrumentation is qualified, compliant, and available for laboratory operations through calibration, maintenance, qualification, and documentation in line with cGMP and quality standards.

Collaborate with QC labs, Engineering, QA, Manufacturing, and external vendors to maintain inspection readiness and drive continuous improvement in

Qualifications

  • Bachelor's degree in Life Sciences or related discipline.
  • Minimum 2 years of experience in a cGMP-regulated pharmaceutical, biotechnology, medical device, or quality control laboratory environment.
  • Working knowledge of cGMP regulations, data integrity principles, and quality systems.
  • Experience with instrument qualification and maintenance practices.
  • Proficiency with computerized systems used in laboratory and quality environments.

Responsibilities

  • Support the qualification, calibration, preventive maintenance, troubleshooting, and retirement of QC laboratory instrumentation.
  • Coordinate instrument lifecycle management to ensure equipment remains compliant, reliable, and fit for intended use.
  • Assist with vendor management and service coordination for laboratory equipment.
  • Support instrumentation documentation and asset management systems.
  • Author, review, and revise GMP documentation (protocols, reports, SOPs, URS, technical assessments).
  • Support laboratory inspection readiness and regulatory audit preparedness.
  • Initiate, investigate, and support resolution of deviations, investigations, CAPAs, and change controls.
  • Lead or participate in projects to improve laboratory efficiency, reliability, and compliance.

Skills

cGMP regulations
Data integrity
Quality systems
Instrument qualification
Computerized systems

Education

Bachelor's degree in Life Sciences or related discipline

Job description

Aequor seeks a Quality Control Instrument Support Specialist II to support lifecycle management of QC instrumentation at the Swiftwater, PA site. You will ensure instrumentation is qualified, compliant, and available for laboratory operations through calibration, maintenance, qualification, and documentation in line with cGMP and quality standards.

Collaborate with QC labs, Engineering, QA, Manufacturing, and external vendors to maintain inspection readiness and drive continuous improvement in

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