Nature and Scope
Perform project related services for TrackWise system implementations, including but not limited to, timeline management, requirements gathering, test case development, protocol generation and execution and end user training for the TrackWise Digital eQMS. This position will support multiple sites. Administer live system and manage various quality processes such as complaints, CAPA, Change Control, Audits, Supplier Quality Management and future module implementations.
Essential Duties and Responsibilities
Nothing in this job description restricts management’s right to assign or reassign duties and responsibilities to this job at any time.
Manages the project plan, including tracking against all major milestones and deliverables.
Communicates with project stakeholders throughout the project life cycle.
Coordinates meetings and schedules necessary resources throughout the project life cycle.
Escalates issues through Sparta or the Company, as appropriate.
Evaluates risks and defines risk mitigation plan.
Reviews validation documentation, as needed by the CSV team.
Reviews documents written by Sparta, as applicable.
Participates in all aspects of the project, from requirements gathering to Go-Live and Support.
Assists in business process definition and TrackWise requirements gathering.
Maintains regular contact with Sparta and participates hands-on in configuration activities.
Manages the User Acceptance Testing of Workflow Activities for the End User Team.
Learns the system to conduct Go-Live support and assists in end-user training.
Assists in the functional testing of the system.
Primary TrackWise system contact with Sparta Support Services.
Training of end users for their specific workflow processes.
Drive requested system enhancements using a risk-based approach to determine validation/regression testing requirements.
Day to day troubleshooting and end user assistance requests.
Perform any other tasks/duties as assigned by management.
Education Requirements and Qualifications
To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill and/or ability required.
Bachelor's Degree in Biology, Chemistry, Public Health or Life Science preferred; candidate with equivalent years of experience will be considered.
Candidate must have 2 or more years’ professional experience in pharmaceutical or healthcare industry.
3 years TrackWise Digital Systems Administration experience in pharmaceutical environment, a plus.
Exceptional influencing and team development skills.
Superior organizational skills.
Must be able to multitask system related items with high priority.
Effective communication skills, both verbal and written.
Solid presentation skills.
The TrackWise Administrator must have experience with the Microsoft office suite: Word, Access, Excel, Visio, PowerPoint and Project.
Expected Salary Range:
$91,300 - $105,000
The salary range, displayed is the minimum and maximum annual salary range of compensation for the role that the employer in good faith believes to be accurate at the time of the posting of an advertisement for the role. Actual compensation for the role will be based on a number of different factors including but not limited to the candidate’s qualifications, education, knowledge, skills and experience.
American Regent also offers a competitive total rewards package which includes healthcare, life insurance, profit sharing, paid time off, matching 401k as well as a wide range of other benefits.
American Regent celebrates diversity and we are committed to creating an inclusive environment for all employees. We are an Equal Opportunity Employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability status, or protected veteran status.
American Regent Inc. endeavors to make https://americanregent.com/Careers accessible to any and all users. If you would like to contact us regarding the accessibility of our website or need assistance completing the application process, please email hrtalentacquisition@americanregent.com.
