What are the responsibilities and job description for the Quality Systems Specialist position at GForce Life Sciences?
Global Quality Solutions Representative
12-month Contract
Hybrid in Princeton, NJ
Responsibilities
- Support the optimization of quality systems by applying a process-centric approach to assess workflows, identify inefficiencies, and implement process improvements.
- Partner with stakeholders to evaluate system enhancement needs, align improvements with business objectives, and support prioritization of initiatives.
- Collect, analyze, and translate business requirements into system configurations within a Quality Management System (QMS) to meet user and compliance requirements.
- Support the evaluation, testing, and implementation of AI capabilities within quality systems.
- Facilitate meetings across Quality teams to communicate QMS process enhancements and gain alignment on new system configurations.
- Provide frontline business support for QMS process requirements.
- Support User Acceptance Testing (UAT) activities, including verification of system configurations.
- Build partnerships with Quality teams and cross-functional stakeholders to support QMS initiatives.
- Support user access management for the Quality Management System.
- Assist with innovation projects related to Quality Operations and risk management.
- Review validation documentation (e.g., URS, FRS, workflow diagrams) for accuracy during system enhancement releases.
- Develop training materials for quality system enhancements as needed.
- Define and implement data standards to support reporting, analytics, and system integrations.
- Lead initiatives to improve data quality and maintain master data management practices.
- Collaborate with Quality and cross-functional teams to develop digital solutions that optimize and streamline processes.
- Partner with IT to resolve ongoing Quality Management System user issues.
Qualifications
- Bachelor's degree, preferably in a scientific discipline.
- 3–4 years of experience with pharmaceutical quality processes and Quality Management Systems.
- Knowledge of pharmaceutical quality standards, TrackWise Digital, and Computer System Validation.
- Understanding of GxP requirements and the drug development and regulatory process.
- Experience with Computer System Validation.
- Ability to influence stakeholders across multiple functions.
- Strong partnership and collaboration skills in a matrixed, multicultural environment.
- Advanced analytical and problem-solving skills.
- Excellent written and verbal communication skills.
- Proficiency with TrackWise, Microsoft Excel, SharePoint, PowerPoint, and Microsoft Teams.