Senior Quality Assurance Auditor - Planet Pharma : Job Details

Senior QA Auditor

Position Details:

• Hiring Timeline: ASAP
• Location: Onsite in Scranton, PA.
• Direct Hire: Permanent Placement
• Compensation: Market Rate - $80,000+ (Dependent on experience)
• Experience Required: 2-3 years
• Education: Bachelor's degree in a scientific discipline or equivalent combination of education and experience.

Top Skills Required:

About the Role

We are seeking a Senior QA Auditor to join our team. In this role, you will be responsible for conducting systematic and independent audits of study-related activities and documents. Your primary goal is to ensure that studies are executed, data is recorded, analyzed, and reported accurately, and that all procedures align with the protocol, standard operating procedures (SOPs), GLP regulations (21 CFR Part 58 and Part 11), and applicable regulatory requirements. The Senior QA Auditor will also report findings to the Study Director, Responsible Person, and Testing Facility Management. Additionally, you will be responsible for mentoring and coaching junior staff while maintaining effective relationships across the organization.

Responsibilities

• Audit various phases of nonclinical and laboratory studies to ensure regulatory compliance.
• Conduct audits across multiple disciplines, including Method Validations and Non-Clinical GLP Studies.
• Perform in-life audits, process audits, vendor qualifications, and equipment/software validation audits.
• Execute facility audits to confirm regulatory compliance.
• Act as the lead auditor for studies and projects, managing audit activities.
• Maintain computerized files and records to support audit activities.
• Support project planning and implementation, providing risk-based compliance opinions and guidance.
• Write and issue detailed inspection reports, ensuring findings are clearly communicated to internal teams.
• Review responses to inspection findings to ensure compliance.
• Ensure that SOPs involved in study execution are current and followed.
• Identify opportunities for process improvements based on audit observations and participate in improvement activities.
• Maintain necessary documentation of QA records and study files.
• Monitor quality and compliance trends, notifying management of any concerns.
• Conduct SOP QA reviews, client hosting, regulatory agency hosting, and external site qualifications.
• Under mentorship, interpret FDA regulations, manage projects, review regulatory guidance, investigate quality issues, and assist with data collection and analysis.
• Recommend procedure modifications when needed, involving management for process improvements.
• Provide training on GLP regulations and offer auditing and process improvement guidance.
• Support self-development and participate in training sessions related to QA, regulatory affairs, and validation.

Qualifications

• Education: Bachelor's degree in a scientific discipline or equivalent combination of education and experience.
• Experience: 2-3 years of technical experience in QA auditing, with at least two years in a GLP-regulated environment.
• Certifications: Professional certifications such as RQAP-GLP (Registered Quality Assurance Professional-GLP) or ASQ-CQA (Certified Quality Auditor) are preferred.
• Skills: Proficiency with Microsoft Office Suite.
• Training: On-the-job training will be provided, with additional opportunities to attend seminars and meetings in Quality Assurance, regulatory affairs, and validation.