Overview
Hybrid
$50 - $60
Contract - W2
Contract - 12 Month(s)
Skills
CSA Validation
GxP Assessment
Risk Assessment (RA)
Validation Plan (VP)
Test Plan (TP)
Validation Summary Report (VSR)
Job Details
Candidates must be LOCAL to the NEW YORK or NEW JERSEY area and COMMUTE into the office THREE TIMES A WEEK. NO RELOCATION CONSIDERED.
- 7-10+ years of successful, progressive experience with Computer System Validation and Computer Software Assurance
- Aptitude in GAMP 5 and 21 CFR Part 11 standards
- Previous experience in a GxP industry or a life sciences industry is required
- Technical competency in FDA regulations
- Expertise in generating, reviewing, and addressing CAPAs
- Strong written and verbal communication skills
- Strong ability to collaborate with the team
- Ability to work self-directed in the timely completion of project deliverables
- Practical experience with Data Integrity and ALCOA+ is a plus
Demonstrated Competencies:
- Technical Competency Develop an understanding of business requirements and work to translate the business requirements to the necessary CSV documents and supporting materials
- Time Management Able to follow strict deadlines, prioritize tasks, and work well under pressure
- Analytical Skills Identifies, researches, and demonstrates logical reasoning to communicate critical information
- Agility Meets objectives by responding to competing and changing priorities and multiple tasks under inflexible timelines
- Strong written and verbal communication skills
- Strong ability to communicate with other COE team members
- Strong analytical and problem-solving abilities
- Understands the purpose of CSA, is passionate about customer safety, data integrity, and product quality
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