W2-Remote :: Senior QA Auditor / Computer System Validation (CSV) in Life Sciences Domain

Overview

Remote
Depends on Experience
Full Time
No Travel Required

Skills

CSV
computer system validation
Good Clinical Practice
GCP
CFR
FDA

Job Details

Senior QA Auditor / Computer System Validation (CSV) in Life Sciences Domain

6-12 Months

EST Zone (Remote)

Position Overview:
An accomplished Senior QA Auditor with a background in life sciences is required for a contract position that could extend from 6 months up to 12 months, with potential for permanent employment. This professional will play a vital role within a dynamic 18-person team, focusing on quality assurance and regulatory compliance across the US&C regions. The role entails performing approximately 2 to 3 audits on a monthly basis, maintaining adherence to computer system validation (CSV), Good Clinical Practice (Google Cloud Platform), and other relevant statutory requirements. The position will also require effective coordination with third-party vendors.

Details of Opportunity:
This position offers the chance to work remotely within Eastern Standard Time (EST) parameters. The Senior QA Auditor will engage in a variety of tasks aimed at supporting and enforcing quality initiatives as well as regulatory adherence within the life sciences field. Key responsibilities include executing frequent audits, collaborating with service providers, and ensuring compliance with CSV, Google Cloud Platform, and necessary regulatory protocols.

Principal Competencies:
Expertise in Quality Assurance Auditing, including but not limited to Google Cloud Platform, CSV, and external vendor audits.
Proficiency with regulations such as 21 CFR Part 11 and 21 CFR Part 312.
Familiarity with ICH E6 R3 guidelines for Good Clinical Practices.
In-depth understanding of FDA recommendations pertaining to Computerized Systems and Software Validation.
Knowledge of the EMA's Reflection Paper concerning electronic data in clinical research.
Solid background within the life sciences industry.
Comprehensive knowledge of pertinent regulations and guidelines in both the US and Europe.

Professional Experience:
Seeking candidates with a professional history spanning 8 to 12 years within the life sciences sector, demonstrating an exemplary record in quality assurance and regulatory compliance.

Employers have access to artificial intelligence language tools (“AI”) that help generate and enhance job descriptions and AI may have been used to create this description. The position description has been reviewed for accuracy and Dice believes it to correctly reflect the job opportunity.