Sr IT Quality Control Specialist - Remote US
Sarah Cannon Research Institute•Nashville, TN
•Remote
About The Position
The Senior IT Quality Control Specialist oversees quality control and assurance of software, process, and data integrity validation processes. Provides guidance and support to operational teams within Sarah Cannon Research Institute to ensure compliance with GxP, 21 CFR Part 11, and regulatory requirements. Works closely and effectively with Global Quality and Education, IT QC Specialists, Validation Specialists, Business Owners, Product Owners, and Product Analysts. This is a remote position based in the US; relocation assistance and visa sponsorship are not available.
Requirements
- Bachelor's Degree required; professional qualified experience may be substituted for education.
- Direct experience in QA/QC role overseeing computerized systems validation
- 5+ years' professional work experience in a clinical research, biotech, or pharmaceutical environment focused in FDA GxP requirements for systems, 21 CFR Part 11 and FDA software validation guidelines.
Nice To Haves
- Experience in GCP clinical space, such as CRO or SMO, is highly preferred
- Experience and knowledge of EU regulations, e.g., Annex 11 is preferred.
- Knowledge of industry and international standards for software quality, such as GAMP V, PIC/S, ICH, etc.
- Knowledge of pharmaceutical, biologics, CRO, and clinical sites 21 CFR Part 11 requirements and software validation principles.
Responsibilities
- Provides guidance to research operations and IT on the interpretation of corporate and regulatory requirements (standards/policies/procedures) related to software validation, quality management, and GxP and oversees quality activities related to software, process, and data integrity validation.
- Provides review of validation life cycle documents including validation assessments, 21 CFR Part 11 assessments, system validation plans, risk management plans, and validation summary reports in adherence with SOPs, corporate policies, standards, and government regulations to ensure completeness and accuracy.
- Provides quality guidance through the cycle of preparation, execution, data analysis, and report writing for IQ, OQ, and PQ protocols.
- Conducts and/or assists with periodic review of system documentation according to defined schedule to ensure continued compliance with SOPs, corporate policies, standards, and government regulations.
- Provides quality review and approval of change request documentation related to changes that impact validated systems and/or processes.
- Other duties as assigned.
Benefits
- Comprehensive benefits to support physical, mental, and financial well-being.
- Competitive compensation package.
- Annual bonus or long-term incentive opportunities may be offered.
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What This Job Offers
Job Type
Full-time
Career Level
Senior
