Senior Quality Assurance Auditor

This is a fully remote position, open to applicants in Pennsylvania.

📋 Description

• Plan, execute, direct, and report on internal, external, vendor/supplier, customer, registrar, and regulatory audits in accordance with relevant Standard Operating Procedures (SOPs) and electronic document management system protocols.

• Oversee and track audit findings, quality incidents, corrective and preventive actions (CAPAs), root cause analysis, and effectiveness evaluations, ensuring timely resolution and escalating significant quality issues when necessary.

• Monitor and analyze audit activities, compliance reports, CAPAs, and quality metrics, effectively communicating significant trends and risks to management.

• Conduct Quality Assurance reviews of source documents, case report forms (CRFs), reports, and system development and validation outputs for accuracy, consistency, and compliance.

• Collaborate with development and cross-functional teams to identify compliance risks, address quality concerns, and implement process enhancements, with a specific emphasis on the audit program and Quality Management System.

• Offer quality-related guidance and training to colleagues, assist in root cause analysis, and mentor staff as assigned.

• Create or update SOPs, support departmental and regulatory standards, and stay informed about current technical and industry knowledge through relevant training.

⛳️ Requirements

• An Associate’s degree or equivalent is required, preferably in life sciences, clinical trials, quality management, computer science, or a related area.

• Certification in quality or quality systems, such as ASQ Auditor certification or equivalent training, or relevant experience.

• A minimum of 5 years of pertinent experience in Quality Assurance, auditing, validation, and/or software development lifecycle (SDLC) systems within a regulated sector, ideally in pharmaceuticals, contract research organizations (CROs), biotechnology, or medical devices.

• In-depth knowledge of Good Clinical Practice (GCP), ICH Guidelines, software validation requirements, Quality Management Systems (QMS), 21 CFR Part 11, Annex 11, and relevant regulations regarding electronic records and electronic signatures.

• Proven leadership experience, including the ability to support, guide, or mentor colleagues.

• Excellent problem-solving, documentation, organizational, interpersonal, and written and verbal communication skills, with the capacity to manage multiple priorities and collaborate effectively across various functions.

• Proficient in common business software, including Microsoft Word and Excel; familiarity with medical and/or clinical trial terminology is a plus.

• Willingness to travel up to 10% and lift up to 25 lbs.; this position may require extended periods of computer use.

🏝️ Benefits

• Competitive compensation.

• Medical, dental, and vision coverage.

• Tuition reimbursement.

• Employee assistance and wellness programs.

• Life and disability insurance.