Quality Specialist, Data Integrity

Triumvira is a multi-national, clinical stage biotechnology company located in Hamilton, Ontario with its headquarters in Austin, Texas.   

We are a fast-paced, innovative, forward-thinking, and highly collaborative culture of scientists, technologists, R&D and other professionals that focus on therapies for small tumors.  Over the last year, our headcount increased by 46% over the last year and we have one of the most exciting portfolios in the Canadian biotech sector! It’s a great time to be part of Triumvira Immunologics.

JOB OVERVIEW

The Data Integrity Quality Specialist coordinates quality assurance program to prevent or minimize risk to the integrity of data, provides independent oversight to the data integrity program for the facility including data generation and review. This inpidual will work in a detail oriented, compliant manner to ensure the facility operations align with corporate policies and procedures as well as cGMPs and industry data integrity expectations. The Quality Specialist will assist in hosting audits and tracking audit responses to ensure they are timely and complete. This role supports the overall quality culture and corporate objectives for regulatory compliance.

JOB DUTIES

Maintain Data Integrity System for the site, including ownership of Data Integrity SOPs and development.

Conduct routine Data Integrity related training.

Performs review of raw data and study reports supporting regulatory filings.

Audits data from batch record review and stability reports for entry to global database.

Review data and summary reports for qualifications, validations, and transfer protocols.

Performs pre and post review of change controls and associated action plans for validation activities.

Audits data from Analytical and Quality Control Laboratories for entry to global database.

Oversees the investigation of discrepancies relating to data integrity.

Provides oversight to stability programs.

Provides oversight and administration of GMP IT Systems (Computerized data systems)

Assist in hosting internal and regulatory audits.

Other duties as required and directed by the relevant Manager

COMPETENCIES

·        Excellent communication skills (written and oral) and capable of leading and directing inter-departmental project teams

·        Strong interpersonal skills

·        Self-motivated, flexible, and a good team player

·        Meticulous, focused, and detail-oriented

·        Excellent organization and time management skills with the ability to prioritize own work based on departmental and site requirements. 

EDUCATION & CERTIFICATIONS 

·        Bachelor’s degree in biology, chemistry, or a related scientific discipline

·        Training or certification in quality field preferred

·        Experience in data integrity

·     Certification in computer system validation, 21 CFR Part 11, and data integrity is desired. 

WORK-RELATED SKILLS & EXPERIENCE

·        2 years’ work experience in quality system processes

·        Knowledge of FDA and Health Canada regulations and standards, especially in the areas of cell therapy, bioanalytical testing, and clinical research a plus

·        Experience in document and data integrity
o   Oversight and management of scientific study reports and data

o   Working knowledge of data management with or without using third-party solutions

o   Working knowledge of Adobe PDF and electronic signature tools.