Description
Duties:Lead/support validation efforts and deliverables for projects requiring validation.
Create and execute validation test scripts and document test results in accordance with standards.
Review and evaluate validation assessments for application systems/projects.
Review/revise validation policy and SOP's as directed.
File validation documentation within following Quality Assurance guidelines.
Utilize business analysis, communication and technical skills to prepare and execute software quality validation to test and implement maintenance release of applications.
Author and submit functional requirements consisting of job flows and program specifications.
Author system requirements and work closely with helpdesk and supplier to determine their information requirements and measure performance against expectations.
Assist in customer resolution.
Lead and execute company product software life cycle and its quality testing documentation, develops preliminary findings for review with business stakeholders and agencies of record and/or management.
SKILLS:
Qualifications:
Outstanding verbal and written communication skills, customer service focused
Information Technology background, experience within a Quality/Regulated environment
System Audit/Validation background/experience
Excellent organizational and project management skills including SDLC
Associate Degree minimum or equivalent combination of education and work experience
Minimum 2 years of experience with validated systems within a regulated industry
Experience writing Standard Operating Procedures and validation policies
Advanced knowledge and understanding of IT concepts and word processing and spreadsheet skills
Laboratory, product, and manufacturing knowledge/experience are a plus
Experience in company software life cycle required.
100% Compliance expected with applicable corporate and divisional policies and procedures, in addition to applicable federal and/or state laws.
Provide level 2 Helpdesk support for the application and its ecosystem
Experience with Software Medical Device applications.
Excellent written and verbal communication skills.