Senior QA Auditor, GLP

CareAbout•Dorval, QC

5d•Onsite

About The Position

At Altasciences, we are dedicated to assisting in the discovery, development, and manufacturing of new drug therapies to expedite their delivery to patients. The Senior QA Auditor, GLP is responsible for conducting systematic and independent examinations (audits) of study-related activities and documents. This role ensures that studies are conducted, and data are recorded, analyzed, and reported in accordance with the protocol, Standard Operating Procedures (SOPs), Good Laboratory Practice (GLP) regulations (21 CFR Part 58 and Part 11), and applicable regulatory requirements. The Senior QA Auditor will report findings to the Study Director or Responsible Person and Testing Facility Management. This position involves building and maintaining effective working relationships across the organization and mentoring junior 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.
Minimum of two years auditing in a GLP-regulated environment.
Microsoft Office Suite.
Good communication (both written and verbal in French & English).

Nice To Haves

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 recommended.
Training needs include on-the-job training in performing audits 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.

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, including Method Validations and Non-Clinical GLP Studies.
Performs process audits, vendor qualifications, and equipment and software validation audits.
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 appropriately address the findings.
Ensures through phase and data inspections that SOPs involved in study conduct 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 and external test site/bioanalytical laboratory qualifications.
Performs 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 assistance is necessary for process improvement/resolution.
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.