Computer System Validation Specialist
2 days ago
We are seeking a highly skilled Computer System Validation Specialist to join our team at Northern Biomedical Research. As a key member of our QA department, you will play a critical role in ensuring the quality and integrity of our computer systems and processes.
Key Responsibilities:- Develop and implement efficient software/computer validation programs for GLP environments
- Identify computerized systems validation needs through in-house assessments or by coordinating needs assessments with external teams
- Partner with business and validation teams for site computer validation projects
- Develop software/computer validation protocols and final reports, as well as coordinate and perform activities per protocols
- Maintain site Master Validation Schedule and periodically review validated systems
- Assist QA in auditing vendors of cGMP-related software and hardware
- Evaluate vendor validations and add company-specific protocols as required to complete validation
- Provide technical counsel on issues and concerns regarding validation plans and protocol designs
- Train company personnel as needed on SOPs
- Minimum: Bachelor's degree or equivalent
- Experience: 5-10 years' experience in Computer System Validations
- Knowledge of GxP
- Level of proficiency necessary for competence in the position as identified by the department training website
- Knowledge of GLPs (21 CFR Part 11) and other federal regulations relating to information technology
- Advanced understanding of laboratory operations and data collection
- Ability to work effectively under time constraints
- Adaptability/Flexibility
- Conflict Resolution
- Critical Thinking
- Resilience
- The person filling this position will spend approximately 80% in an office setting and 20% in the laboratory
- Exposure to animal pathogens and chemicals
- Handling of, and/or exposure to animal tissue and zoonotic organisms
- Ability to don and wear personal protective gear, including N95 masks and respirators
- Physical Requirements: Ability to lift and carry up to 50lbs. Occasionally ascend/descend ladders and stairs
- Ability to work beyond typical work schedule, including evenings, weekends, extended shifts with short notice
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