Sr. QA Auditor

Must sit onsite in their Scranton location- 130 Discovery Drive Scott Township, PA 18447

Open on salary based on experience - 60k - 100k

REQUIRED:

• 2-3 years of related QA experience
• Minimum of two years auditing in a GLP-regulated environment
• Professional certification such as RQAP-GLP (Registered Quality Assurance Professional-GLP) or ASQ-CQA (American Society of Quality– Certified Quality Auditor) or other certification is preferred
• Microsoft Office Suite
• Training needs for this position include on-the-job training in performing audits and inspections, and independent reading of professional articles, journals and internal SOPs. Attendance at training seminars, regional and national meetings in Quality Assurance, regulatory affairs and validation, along with continual GLP training.

What You'll Do Here

• Audits phases of nonclinical and laboratory studies, reports, and performs related duties (e.g., issues audits and QA statements) to ensure regulatory compliance.
• Audits all disciplines (examples of disciplines include Method Validations, Non- Clinical GLP Studies).
• Performs in-life audits, process audits, vendor qualifications, equipment and software validation audits.
• Performs facility audits to ensure that the facility is in compliance with regulations.
• Acts as lead auditor on studies and projects.
• Maintains computerized files to support audit activities.
• Supports project planning and implementation.
• Provides risk-based compliance opinions and guidance.
• Writes and issues inspection reports. Works with internal clients to ensure that inspection findings are clearly communicated and understood. Evaluates inspection finding responses to ensure they are written to address the findings appropriately.
• Ensures through phase and data inspections that the SOPs, which are involved in the conduct of a study, are current and practiced.
• Identifies and communicates opportunities for process improvements based on audit and inspection observations. Participates in and guides process improvement activities in both small intradepartmental groups as well as complex and possible multi-departmental interactions.
• Maintains necessary documentation of QA records and study files.
• Notifies management of observed quality and compliance trends in the areas inspected.
• Autonomously performs SOP QA review, client hosting, regulatory agency hosting and external test site/clinical site/bioanalytical laboratory qualifications.
• Under supervision of a mentor/coach, performs the following tasks: interpretation of FDA, regulations; project management; regulatory guidance review; quality issue investigations; and QA data collection, trending and analysis.
• Recommends modifications in procedures to fit special needs or problems and involve manager when assistance in process improvement/resolution is necessary.
• Interprets and can train on GLP and associated regulatory documents to facilitate auditing and process improvement recommendations.
• Carries out appropriate self-development efforts as directed.
• Assists with regulatory training of staff.