Senior QA Auditor

CareAbout

114d

About The Position

The Senior QA Auditor is responsible for carrying out systematic and independent examination (i.e., audit) of multiple study related activities and documents, to determine whether the evaluated study related activities were conducted, and the data were recorded, analyzed, and accurately reported according to the protocol, standard operating procedures (SOPs), GLP (21 CFR Part 58 and Part 11) and the applicable regulatory requirements. The Senior QA Auditor is responsible for reporting any findings to the Study Director or Responsible Person and Testing Facility Management. The Senior QA Auditor is responsible for building and maintaining effective working relationships throughout the organization and is responsible for mentoring/coaching lower-level staff.

Requirements

• Bachelor degree or higher in a scientific discipline, or equivalent combination of education and experience.
• Two to three years related technical experience and/or training.
• A minimum of two years auditing in a GLP-regulated environment.
• Professional certification such as RQAP-GLP or ASQ-CQA is recommended.
• Microsoft Office Suite proficiency.

Nice To Haves

• Attendance at training seminars, regional and national meetings in Quality Assurance, regulatory affairs and validation.
• Continual GLP training.

Responsibilities

• Audits phases of nonclinical and laboratory studies, reports, and performs related duties to ensure regulatory compliance.
• Audits all disciplines including Method Validations and Non-Clinical GLP Studies.
• Performs in-life audits, process audits, vendor qualifications, equipment and software validation audits.
• Performs facility audits to ensure 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 SOPs 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.
• Maintains necessary documentation of QA records and study files.
• Notifies management of observed quality and compliance trends in the areas inspected.
• Performs SOP QA review, client hosting, regulatory agency hosting and external test site/clinical site/bioanalytical laboratory qualifications.
• Interprets 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.
• Interprets and can train on GLP and associated regulatory documents.
• Carries out appropriate self-development efforts as directed.
• Assists with regulatory training of staff.

Benefits

• Health/Dental/Vision Insurance Plans
• 401(k)/RRSP with Employer Match
• Paid Vacation and Holidays
• Paid Sick and Bereavement Leave
• Employee Assistance & Telehealth Programs
• Training & Development Programs
• Employee Referral Bonus Program
• Annual Performance Review

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level
• Education Level: Bachelor's degree
• Number of Employees: 251-500 employees