Sr Quality Assurance Auditor

Location: Philadelphia, Pennsylvania, United States; Pennsylvania remote also listed

Company

hirify.global, part of Thermo Fisher Scientific, develops technology and supports clinical science to help advance life-changing therapies.

What you will do

• Plan, conduct, lead, and report internal, external, vendor or supplier, customer, registrar, and regulatory audits according to SOPs and electronic document management processes.
• Manage audit findings, quality events, CAPAs, root cause activities, effectiveness checks, and timely closure, escalating significant quality concerns when appropriate.
• Track and trend audit activities, compliance reports, CAPAs, and quality metrics, communicating significant risks and trends to management.
• Review source documents, case report forms, reports, and system development and validation deliverables for accuracy, consistency, and compliance.
• Partner with development and cross-functional teams to identify compliance risks, resolve quality issues, improve processes, and strengthen the QMS.
• Provide quality guidance and training, mentor colleagues, develop or revise SOPs, and maintain technical and industry knowledge through training.

Requirements

• Associate’s degree or equivalent is required, preferably in life sciences, clinical trials, quality management, computer science, or a related field.
• Quality or quality systems certification, such as ASQ Auditor certification or auditor training, or equivalent experience.
• At least 5 years of relevant experience in Quality Assurance, auditing, validation, and/or SDLC systems within a regulated industry, preferably pharmaceutical, CRO, biotechnology, or medical device.
• Strong working knowledge of GCP, ICH Guidelines, software validation requirements, QMS, 21 CFR Part 11, Annex 11, and applicable electronic records and electronic signatures regulations.
• Demonstrated leadership experience, including supporting, guiding, or mentoring colleagues.
• Strong problem-solving, documentation, organizational, interpersonal, written, and verbal communication skills, with the ability to manage multiple priorities and collaborate across functions.
• Proficiency with Microsoft Word and Excel.
• Ability to travel up to 10%, lift up to 25 lbs., and work at a computer for extended periods.

Nice to have

• Familiarity with medical and/or clinical trial terminology.
• Experience in pharmaceutical, CRO, biotechnology, or medical device environments is preferred.

Culture & Benefits

• Medical, dental, and vision coverage.
• Tuition reimbursement.
• Employee assistance and wellness programs.
• Life and disability insurance.
• Inclusive workplace committed to diversity and equal opportunity.