GLP QA Lead: Preclinical & Translational Research

University of Pennsylvania

Philadelphia (Philadelphia County)

On-site

USD 59,000 - 90,000

Full time

14 days+

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Benefits offered by this job

Health insurance

Tuition benefits

Retirement plans

Time off

Job summary

University of Pennsylvania, located in Kennett Square, PA, seeks a Quality Assurance Officer to manage GLP compliance for PSC-CORL and related facilities. The role ensures audits, SOP reviews, and training while coordinating inspections with FDA, IACUC, and USDA.

The position supports preclinical labs and cross-facility QA activities. The QA Officer will maintain GLP archives, develop SOPs, and guide staff on regulatory compliance, contributing to Penn’s high standards in research integrity and

Qualifications

Experience working in a GLP environment.
Strong knowledge of GLPs is required.
Experience in medical device development and/or gene therapy is preferred.
Ability to work collaboratively, multi-task, and prioritize in a fast-paced environment.
Strong analytical skills and attention to detail are required.
Experience meeting mission-critical deadlines.
Proficiency with Microsoft Word, Excel, and Access is required.

Responsibilities

Perform inspections and audits against study protocols and SOPs.
Review SOPs and training records to ensure standards.
Review study protocols and final written reports for GLP compliance.
Conduct facility audits and vendor qualifications.
Provide corrective actions with input from leadership.
Train staff on GLP and regulatory compliance.
Maintain on-site archives of retained study data and coordinate learner onboarding.