Clinical IT Quality Control Analyst
New
J
JobgetherClinical Research
Based in United StatesFull-TimeMiddle
SalaryCompetitive compensation based on factors including experience, skills, performance, equity considerations, market conditions, and geographic location. Potential eligibility for additional compensation such as annual bonus or long-term incentive opportunities.
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Job Details
- Experience
- At least 3 years of professional experience in clinical research, biotechnology, pharmaceutical, or a related regulated environment.
- Required Skills
- Quality Assurance
Requirements
- Bachelor’s degree or equivalent professional experience.
- Direct experience in a quality assurance or quality control role involving computerized systems validation.
- At least 3 years of experience in clinical research, biotechnology, pharmaceutical, or a related regulated environment.
- Strong experience with FDA GxP requirements for computerized systems and 21 CFR Part 11.
- Experience with FDA software validation guidance.
- Knowledge of software quality and validation standards such as GAMP V, PIC/S, and ICH.
- Understanding of clinical-site requirements relating to computerized systems validation.
- Strong analytical and documentation review skills for complex validation materials.
- Effective communication and collaboration skills for working across cross-functional teams.
- Ability to manage multiple priorities in a deadline-driven environment.
Responsibilities
- Provide quality and compliance guidance regarding software validation, quality management, GxP requirements, and regulatory standards.
- Oversee quality activities for software, processes, and data-integrity validation within computerized systems.
- Review validation lifecycle documentation including 21 CFR Part 11 assessments, validation plans, risk-management plans, and summary reports.
- Ensure validation documentation is accurate and aligned with SOPs, corporate policies, and regulatory requirements.
- Support quality activities throughout the preparation, execution, and reporting phases of IQ, OQ, and PQ protocols.
- Conduct periodic reviews of system documentation to confirm ongoing compliance with regulations.
- Perform quality reviews of changes affecting validated systems to ensure appropriate controls are maintained.
- Collaborate with IT QC, validation specialists, business owners, and global quality teams.
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