Apply the GAMP 5 Validation Life-cycle to Chemistry, Microbiology, and Environmental Monitoring and Controlled Temperature Units.
*** Develop validation documentation including GxP Assessments; Change Control; Validation Plans; Risk Assessments; Requirements, Design, and Functional Specifications; Supplemental Installation, Operational, and Performance Qualification Protocols; Traceability Matrices; Summary and Final Reports; and Standard Operating Procedures.
***Schedule validation and validation life-cycle deliverables.
*** Manage vendor installations and validation documentation.
*** Perform Gap Analysis on existing laboratory assets.
*** Conduct periodic assessments of previously validated assets.
*** Troubleshoot vendor instrument software applications.
*** Provide regulatory guidance regarding compliance with intended specifications, policies affecting final product integrity, and regulations to clients.
*** Provide site specific team management for junior level resources such as mentoring, guidance, and peer review.
Offering company vehicle, full benefits, paid time off for holidays, sick days, vacations and more, 401(k) retirement plan with matching, company credit card, daily stipend, corporate sponsored training and opportunities for advancement.
Please reference #37747101 when responding.Education Requirements: Bachelor DegreeMinimum Experience Requirements: 2-5 yearsJob City Location: EdisonJob State Location: NJJob Country Location: USA