IT Quality Assurance Associate

Payrate: $ 50.00 - $ 60.00/hr.

Position Summary:

The IT Quality Assurance Associate will support the implementation and operational aspects of IT systems while ensuring compliance with internal and external regulatory requirements.

Primary Job Responsibilities:

• Provide compliance guidance across IT and stakeholders, focusing on computerized system validation (CSV) in a GxP-regulated environment.
• Lead and oversee the validation and qualification processes for GxP computerized systems and infrastructure, both on-premises and cloud-based, ensuring adherence to 21 CFR Part 11 compliance and other relevant regulations.
• Review and approve CSV lifecycle documents, including validation plans, requirements, risk assessments, and validation summary reports.
• Evaluate new computerized systems or software for GxP impact and provide risk-based validation guidance.
• Review incidents and changes to computer systems for GxP impact, identifying necessary validation or qualification requirements.

Qualifications:

• Education: Bachelor’s degree in Computer Science, Information Technology, Life Sciences, or a related field.
• Experience: Minimum of 4 years of direct experience in validation within the pharmaceutical, biotechnology, or regulated healthcare industry.
• Proven experience in IT compliance and validation within a GxP-regulated environment, specifically with 21 CFR Part 11 compliance.
• Strong understanding of computerized system validation principles, regulatory requirements, and quality management systems.
• Excellent project management skills, with the ability to lead cross-functional teams and manage multiple projects simultaneously.
• Exceptional communication and interpersonal skills, with the capacity to work collaboratively with internal and external stakeholders.
• Detail-oriented with a strong analytical mindset and problem-solving capabilities.

Top Skills Required:

• Strong knowledge of regulatory guidelines and standards related to computer system validation in the pharmaceutical industry (e.g., FDA 21 CFR Part 11, GAMP 5).
• Experience in validating computerized systems used in the pharmaceutical industry.
• Knowledge of validation methodologies, risk assessment techniques, and validation documentation practices.

Pay Transparency:

The typical base pay for this role across the U.S. is: $ 50.00 - $ 60.00 /hr. Final offer amounts, within the base pay set forth above, are determined by factors including your relevant skills, education and experience and the benefits package you select. Full-time employees are eligible to select from different benefits packages. Packages may include medical, dental, and vision benefits, 10 paid days off, 401(k) plan participation, commuter benefits and life and disability insurance.

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