Senior QA Auditor

About the Role

As a Senior QA Auditor, you will carry out systematic and independent examinations (i.e., audits) 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 applicable regulatory requirements. You will report findings to the Study Director or Responsible Person and Testing Facility Management. Additionally, you will build and maintain effective working relationships throughout the organization and mentor/coach lower-level staff.

Responsibilities

• 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 (e.g., Method Validations, 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 and works with internal clients to ensure findings are clearly communicated and understood.
• Evaluates inspection finding responses to ensure they address the findings appropriately.
• Ensures through phase and data inspections that 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 in both small intradepartmental groups and complex multi-departmental interactions.
• Maintains necessary documentation of QA records and study files.
• Notifies management of observed quality and compliance trends in inspected areas.
• Autonomously performs SOP QA review, client hosting, regulatory agency hosting, and external test site/clinical site/bioanalytical laboratory qualifications.
• Under supervision, performs tasks such as 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 involves management when necessary.
• Interprets and trains 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.

Requirements

• Bachelor's degree or higher in a scientific discipline, or equivalent combination of education and experience.
• 2-3 years of related technical experience and/or training.
• A 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) is recommended.
• Well-versed with Microsoft Office Suite.

Training needs for this position include on-the-job training in performing audits and inspections, 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.

Work Authorization & Sponsorship

Applicants must be legally authorized to work in the United States. Altasciences is unable to provide sponsorship, sponsorship transfers, or visa maintenance for this position.

Pay

The pay range estimated for this position is $80,000 - $87,000 annually. Hourly rates/salaries vary within the range based on factors including, but not limited to, prior relevant experience, skills, education, certification, location, as well as internal equity and market data.

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
• Telework when applicable

Incentive Programs

• Training & Development Programs
• Employee Referral Bonus Program