GxP Application Specialist (Temporary) - United States
- Our company is the world leader in delivering therapeutics that provide meaningful advances to patients who live with serious and life-threatening rare genetic diseases. We target diseases that lack effective therapies and affect relatively small numbers of patients, many of whom are children.
- These conditions are often inherited, difficult to diagnose, progressively debilitating and have few, if any, treatment options.
- Our company will continue to focus on advancing therapies that are the first or best of their kind.
- 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.
- Gather software specific requirements and draft SDLC documents
- Research system/software functionality to determine suitability and it’s capability of meeting User Requirements and Data Integiry standards
- Perform hands on configuration of the software (using standard out of the box tools and GUI) to meet specific lab process requirements (for example setting boolian fields, and defineing user Roles/permissions)
- Ensure that System Owner & SMEs understand how the system meets their requirements
- Assist in the development of Risk Assessment, IQ,OQ and PQ protocols by leveraging your software/system specific expertise to help the Validation group produce these deliverables.
- Draft SOPs, work instructions and other training materials
- Document, and communicate project outcomes (Positive/Negative) to management and participate in efforts to constantly improve the implementation process.
- Assist in ad-hoc projects as needed to address deviation investigations or initiatives.
- Organize project meetings, and perform standard meeting organizer duties (agenda, minutes action items etc.)
- Perform post-go-live routine application support and training as needed
- 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
- Minimum: BA/BS degree in either Life sciences (Microbiology, Biology, Biochem, Analytical Chemistry etc.) or Computer Science/MIS related degrees ~ Or a minimum of 6 years direct experience in a similar role with escalating levels of responsibility will be considered