Overview Staff Quality Systems Specialist - Records, Document Management, Systems & Education #4348 at BioSpace. As part of the Compliance, Operations, Records, and Education (C.O.R.E.) organization, the Quality Systems Specialist will support the maintenance, delivery, and continuous improvement of GRAIL’s Records and Document Management, Systems, and Education, with emphasis on the electronic Quality and Learning Management System (Veeva). This role is a hands-on resource reporting to the Director, Compliance, Operations, Records, and Education (C.O.R.E. Team) and requires routine coordination with cross-functional Quality colleagues, business stakeholders, and leadership. This role requires on-site work at GRAIL’s Durham, NC facility approximately 3 days a week. Note: The posting indicates the role is part of BioSpace and references GRAIL; this description preserves the information as provided.

Responsibilities Ensure compliance with company processes and procedures, and applicable FDA QSR, IVDD/IVDR, ISO, CAP/CLIA, and NYS regulations and/or guidelines. Oversee and continually improve processes supporting GRAIL’s electronic Quality Management System (eQMS) and Learning Management System. Lead continuous quality system process improvements, workflow implementations, and system configurations within Change Management, including Document Control, Change Control, and Quality Training. Maintain user requirements and develop comprehensive validation test protocols. Create and deliver educational presentations on change management programs (new hire, process updates, etc.). Maintain controlled documents, track change management processes, and edit documents to ensure formatting, legibility, completeness, and adherence to templates and procedures. Coordinate review, approval, and archival of controlled documents within timelines and internal policies/regulations. Collaborate with change owners and cross-functional partners to ensure effective implementation; identify non-compliance, risk, or improvement areas and develop action plans. Respond to inbound document inquiries and maintain effective cross-functional communications to advance quality activities and standard methodologies. Address NCRs, CAPAs, and internal/external audit findings related to document management. Generate data for KPIs/metrics for management reviews and provide document control support for audits and inspections. Assist Quality Systems Software Owner/SME with validation and configuration maintenance/improvements, including testing for system implementations and updating SOPs, reports, protocols, and specifications; document feedback to improve end-user experience. Cultivate relationships with partners, leadership, and cross-functional teams, including vendors/consultants; understand interrelationships to improve document control processes. Assess unusual circumstances and use analytical/problem-solving techniques to identify causes, resolving issues creatively and compliantly, and suggesting process variations as needed. Qualifications Bachelor’s degree and experience developing, implementing, and leading quality or regulatory activities, or equivalent knowledge/experience. 8+ years of related experience in quality management, preferably with Document and Records Management (Masters & 5+ years of related experience). Working knowledge of regulations and standards including QSR, ISO 13485, CAP/CLIA, NYS, ISO 15189, IVDR, and other applicable industry requirements. Experience using an electronic Document Management System (eDMS); Veeva Vault highly preferred. Proven ability to manage workload under tight deadlines and pressure with composure. Demonstrated ability to perform meticulous work with high accuracy and completeness. Compensation and Benefits Expected full-time annual base pay scale for this position is $114K - $142K. Actual base pay will consider skills, experience, and location. Colleagues may be eligible for an annual bonus plan tied to company and individual performance, or an incentive plan. A long-term incentive plan is also offered to align company and colleague success over time. GRAIL offers a progressive benefits package, including flexible time-off, a 401(k) with company match, and medical/dental/vision plans with mindfulness offerings. GRAIL is an Equal Employment Opportunity employer and does not discriminate on the basis of race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability, or any other legally protected status. Reasonable accommodations are available for applicants and employees with disabilities. GRAIL maintains a drug-free workplace. Location and Posting Notes Location: Durham, NC (on-site approximately 3 days/week).

#J-18808-Ljbffr