Senior Quality Systems Specialist Job Description Template
Our company is looking for a Senior Quality Systems Specialist to join our team.
Responsibilities:
- Responsible for oversight and maintenance of KPIs and metrics associated with the Sage NC/CAPA program;
- Site-wide communication related to changes and requirements associated with upgrades to the TrackWise enterprise system;
- Assess trade-offs for changes to project scope, schedule, and costs that impact the program and related projects;
- Creates and maintains a program risk assessment to ensure program risks are identified and closed;
- Responsible for oversight and execution of the NC/CAPA program within the TrackWise enterprise system;
- Coordinates with partners and end users to deliver values to business through opportunity identification, solution delivery, and ongoing support;
- Functions as Lead Auditor to schedule, plan, perform, and document internal audits of Cepheid’s QMS;
- Manages and maintains tracking mechanisms to support the various quality systems elements and ensures visibility throughout the organization;
- Serves as the document control system owner for Lung Biotechnology and support teams in creation/revision of standard operating procedures;
- Participate in MDSAP preparation, assessment, and audit management activities;
- Participates in site quality and provides recommendations for process improvement initiatives;
- Be a subject matter expert on Internal Audit and CAPA practices;
- Manages and tracks CAPAs resulting from audits/inspections as well as any other compliance remediation plans;
- Interfaces with United Therapeutics Global compliance team for electronic system updates, user requirements, training, and troubleshooting;
- Participates in external audits (e.g. FDA, ISO, Danaher Corporate).
Requirements:
- Ability to work in an office environment;
- 5 years’ experience in a GxP environment, biotech, pharma, medical device industry with at least 2-3 years in a Quality/Compliance function;
- Proficiency in Microsoft Office Suite and Windows Applications;
- Bachelor’s degree in a Life Sciences or similar discipline;
- Understanding of industry practices and processes to support and manage creation and revision of standard operating procedures;
- Any quality or GxP certification;
- Proficiency with Smartsheet and Visio organizational tools;
- Lead Auditor Certification or CQA(B);
- Experience with conducting end user training in a classroom environment;
- Excellent written and verbal communication skills;
- Experience with electronic quality management systems for tracking training, document management, and Deviation/CAPA;
- Certifications in quality or quality systems;
- Have the knowledge and ability to apply basic scientific and regulatory principles to improve quality systems;
- Trackwise and Master Control.