The GxP Application Specialist will implement Instrument based software (COTS) in the Quality Control labs. The Application Specialist is a hands on, individual contributor that will help ensure that systems are implemented efficiently (following a standard process) so that the lab can maintain a high standard of efficiency and compliance with current data Integrity requirements.
Minimum of 3 years direct experience implementing and/or validating software in a regulated environment following the GAMP guidance
A desire to solve compliance and process problems through the implementation of laboratory systems
Strong grasp of current data integrity standards
Basic Project Management Skills
Experience/Knowledge of good requirements gathering techniques including process mapping techniques. (Example LEAN, SIX SIGMA etc.)
Experience generating SDLC deliverables particularly URS, FRS and CS
Strong interpersonal communication skills including, formal presentations, meeting management, negotiation/persuasion and conflict resolution.
Self-motivation, and be a quick learner of business processes and technology
Microsoft Office(or similar) skills including Word, Excel, PowerPoint, Visio, and Project
Highly Desired Skills/Experience:
Laboratory background with bench level experience executing common QC methods/tests/experiments
Experience in standard software development and testing methodologies (Rapid, Waterfall, etc., Regression testing, Black-box, Positive, Negative, Boundary, UAT etc.)
Experience initiating and managing Change Control, and Deviations requests with TrackWise
Highly Desired: ASQ, PMI certifications