Energy Jobline ZR
Staff Quality Systems Specialist - Records, Document Management, Systems & Educa
Energy Jobline ZR, Durham, North Carolina, United States, 27703
Quality Systems Specialist – GRAIL
The Quality Systems Specialist will support the maintenance, delivery, and continuous improvement of GRAIL’s Records and Document Management, Systems, and Education, with an emphasis on the electronic Quality and Learning Management System (Veeva).
This role must be able to work on-site from GRAIL’s Durham, NC facility approximately 3 days a week.
Responsibilities
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) and Learning Management System.
Lead continuous quality system process improvements, workflow implementations, and system configurations associated with the Change Management program, encompassing Document Control, Change Control, and Quality Training.
Maintain program user requirements and develop comprehensive validation test protocols.
Create and lead educational presentations on change management programs (new hire, process updates, etc.)
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.
Generate data for key performance indicators (KPIs)/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. Understand the interrelationships of different disciplines and how these connections can be used to improve Document Control processes.
Assess unusual circumstances and use sophisticated analytical and problem solving techniques to identify causes. Resolve a wide range of issues in creative but compliant ways and suggest variations in approach.
Qualifications
Bachelor’s degree and experience developing, implementing, and leading quality or regulatory activities or equivalent knowledge or experience.
8+ years of related experience (Masters & 5+ years of related 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, ISO 13485, IVDR, and other applicable industry requirements.
Experience using an eDMS required; Veeva Vault highly desired.
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.
Expected full‑time annual base pay scale for this position is $114K - $142K. Actual base pay will consider skills, experience, and location.
In addition, GRAIL offers a progressive benefit package, including flexible time‑off, a 401(k) with a company match, and comprehensive medical, dental, and vision plans, alongside carefully selected mindfulness offerings.
GRAIL is an Equal Employment Opportunity Employer and does not discriminate on the basis of race, color, religion, sex, national origin, age, disability, or any other protected characteristic. GRAIL will reasonably accommodate all individuals with disabilities so that they can participate in the job application or interview process, perform essential job functions, and receive other benefits and privileges of employment. GRAIL maintains a drug‑free workplace.
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This role must be able to work on-site from GRAIL’s Durham, NC facility approximately 3 days a week.
Responsibilities
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) and Learning Management System.
Lead continuous quality system process improvements, workflow implementations, and system configurations associated with the Change Management program, encompassing Document Control, Change Control, and Quality Training.
Maintain program user requirements and develop comprehensive validation test protocols.
Create and lead educational presentations on change management programs (new hire, process updates, etc.)
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.
Generate data for key performance indicators (KPIs)/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. Understand the interrelationships of different disciplines and how these connections can be used to improve Document Control processes.
Assess unusual circumstances and use sophisticated analytical and problem solving techniques to identify causes. Resolve a wide range of issues in creative but compliant ways and suggest variations in approach.
Qualifications
Bachelor’s degree and experience developing, implementing, and leading quality or regulatory activities or equivalent knowledge or experience.
8+ years of related experience (Masters & 5+ years of related 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, ISO 13485, IVDR, and other applicable industry requirements.
Experience using an eDMS required; Veeva Vault highly desired.
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.
Expected full‑time annual base pay scale for this position is $114K - $142K. Actual base pay will consider skills, experience, and location.
In addition, GRAIL offers a progressive benefit package, including flexible time‑off, a 401(k) with a company match, and comprehensive medical, dental, and vision plans, alongside carefully selected mindfulness offerings.
GRAIL is an Equal Employment Opportunity Employer and does not discriminate on the basis of race, color, religion, sex, national origin, age, disability, or any other protected characteristic. GRAIL will reasonably accommodate all individuals with disabilities so that they can participate in the job application or interview process, perform essential job functions, and receive other benefits and privileges of employment. GRAIL maintains a drug‑free workplace.
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