Quality Systems Specialist
Change Management, Durham, NC
Posted on 6/7/2022
Raleigh, NC, USA • Durham, NC, USA
- Bachelor's degree and experience developing, implementing and leading quality or regulatory activities or equivalent knowledge or experience
- Minimum of 3 years of experience performing a quality management function, preferably with experience in Document and Records Management
- Working knowledge and understanding of regulations and standards, including but not limited to QSR, ISO 13485 Quality System, CAP/CLIA, NYS, ISO 15189 and other applicable industry requirements
- Experience using an eDMS required; Veeva Vault highly preferred
- Proven ability to efficiently manage workload under tight deadlines and pressure in a composed manner
- Demonstrated ability to perform meticulous work with a high degree of accuracy and completeness
- Requires exceptional interpersonal, verbal and written communication skills are essential in this collaborative work environment
- Comfortable in a fast-paced environment with minimal direction and able to be flexible
- Demonstrated project management experience developing processes and leading their implementation in a cross-functional environment
- Ability to adapt to changes in the work environment; manages competing demands; changes approach or method to best fit the situation
- Ability to deal with frequent change, delays, or unexpected events
- Experience with auditing and experience representing and responding to regulatory agency audits
- Proficiency with standard office software applications including Microsoft Office, Google Suite, and Zoom
- Ensure compliance with company processes and procedures, as well as applicable FDA QSR, IVDD/IVDR, ISO, CAP/CLIA, and NYS regulations and/or guidelines
- Responsible for the oversight and continuous improvement of efficient, effective, and compliant processes supporting GRAIL's electronic Quality Management System (eQMS)
- Support continuous quality system process improvements, workflow implementations, and system configurations associated with the Change Management program, encompassing Document Control and Change Control
- Maintain controlled documents, track document change management processes, and edit documents to ensure formatting, legibility, completeness, and adherence to GRAIL's controlled templates, procedures, and other relevant processes
- Coordinate the review, approval, and archival of GRAIL's controlled documents in accordance with strict timelines as well as internal policies and regulations
- Collaborate and provide mentorship to change owners, approvers, and cross-functional owners, ensuring effective implementation of change. Call out areas of non-compliance, risk and/or potential improvement to management and develop plans for appropriate action to address causes of deficiencies
- Respond to all inbound document-related inquiries and maintain effective cross-functional team communications to advance GRAIL's quality activities and promote standard methodologies
- Address, respond-to, and complete NCRs, CAPAs, and Internal/External Audit Findings associated with document management needs and gaps, and provide company training metrics for management reviews
- Provide document control support for internal and external audits and inspections
- Assist the Quality Systems Software Business Owner/SME with validation and configuration maintenance/improvements, including testing for system implementations and updating documents (SOPs, reports, protocols, specifications, etc.), as well as documenting, assessing, and resolving feedback to improve the end user experience, as needed
- Cultivate positive relationships with key partners, leadership team members, and other cross-functional partners throughout GRAIL, including third-party vendors/consultants
Designs cancer screening tests
GRAIL's mission is to detect cancer early, when it can be cured. They are working to change the trajectory of cancer mortality and bring stakeholders together to adopt innovative, safe, and effective technologies that can transform cancer care.
- Outstanding People - Join a team of passionate and dedicated professionals, committed to collaboration, education, and proactive problem-solving.
- Strong Compensation - We offer competitive salaries and savings plans to provide for long-term financial planning.
- Complete Health Coverage - Take advantage of comprehensive health coverage, with medical, dental and vision, to keep you and your family healthy.
- Work-Life Balance - Make everyday life more manageable with flexible time off – we trust you to do great work and take time for yourself.
- Grit - We are determined and resilient because patients are counting on us.
- Respect - We value diversity and challenge each other respectfully.
- Accountability - We own our decisions and keep our commitments.
- Integrity - We adhere to our principles of humility, transparency, and rigor.
- Leadership - We make each other better by making leadership everyone’s responsibility