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GRAIL jobs in Raleigh, NC

- 34 jobs
  • Customer Service Operations Lead #4404

    Grail 4.2company rating

    Grail job in Durham, NC

    Our mission is to detect cancer early, when it can be cured. We 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. We are a healthcare company, pioneering new technologies to advance early cancer detection. We have built a multi-disciplinary organization of scientists, engineers, and physicians and we are using the power of next-generation sequencing (NGS), population-scale clinical studies, and state-of-the-art computer science and data science to overcome one of medicine's greatest challenges. GRAIL is headquartered in Menlo Park, California, with locations in Washington, D.C., North Carolina, and the United Kingdom. It is supported by leading global investors and pharmaceutical, technology, and healthcare companies. For more information, please visit grail.com. GRAIL is seeking an Operations Lead for GRAIL's Customer Service Team. We are seeking a Customer Service Operations Lead to drive the execution of strategic initiatives, optimize processes, and serve as the primary point of contact for customer service-related operations. In this role, you will oversee the daily operations of the Customer Service Call Center to prepare and implement policies, objectives, and initiatives focused on delivering a customer-centric, best-in-class call center. This role is ideal for someone who excels at problem-solving, cross-functional collaboration, analytics, and execution. The ideal candidate will have a strong background in operations, a data-driven mindset, and the ability to execute end-to-end programs that enhance the customer experience and support business goals. This is a hybrid role, 2 days onsite in Menlo Park, CAResponsibilities Lead the development and implementation of new customer service programs, tools, and initiatives from concept through completion. Act as the primary point of contact for internal stakeholders on all customer service operational initiatives. Analyze performance data to identify pain points, trends, and opportunities for improvement. Build reporting frameworks and dashboards to monitor key performance indicators. Prepare reports for upper management or other departments, including production statistics and forecasting projections. Optimize and document workflows to improve efficiency, scalability, and quality of service. Develop and refine standard operating procedures (SOPs) for customer service operations. Ensure readiness and alignment across teams for new launches, process updates, and operational changes. Research best practices, tools, and emerging trends in customer service operations. Identify and test new models or technologies to enhance team performance and the customer experience. Preferred Qualifications Bachelor's degree or equivalent experience required 8+ years of experience in customer service, operations, or a related field Proven experience leading operational initiatives or programs. Strong analytical skills with the ability to interpret complex data sets and drive insights. Demonstrated ability to collaborate cross-functionally and manage multiple priorities. Solid project management skills and ability to influence and drive decision making. Familiarity with contact center tools and technologies (e.g., CRM- SalesForce, ticketing systems, knowledge bases). Excellent verbal and written communication skills. Experience managing teams or mentoring others, even in an unofficial capacity, preferred. Experience in fast-paced, high-growth environments. Prior exposure to CX tools, automation platforms, or workforce planning Knowledge of project management tools and methodologies. The expected, full-time, annual base pay scale for this position is $97K-$121K. Actual base pay will consider skills, experience, and location. Based on the role, colleagues may be eligible to participate in an annual bonus plan tied to company and individual performance, or an incentive plan. We also offer a long-term incentive plan to align company and colleague success over time. In addition, GRAIL offers a progressive benefit package, including flexible time-off, a 401k with a company match, and alongside our medical, dental, vision plans, carefully selected mindfulness offerings. GRAIL is an Equal Employment 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. We will reasonably accommodate all individuals with disabilities so that they can participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment. Please contact us to request accommodation. GRAIL maintains a drug-free workplace.
    $29k-36k yearly est. Auto-Apply 60d ago
  • Staff Quality Systems Specialist - Records, Document Management, Systems & Education #4348

    Grail 4.2company rating

    Grail job in Durham, NC

    Our mission is to detect cancer early, when it can be cured. We 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. We are a healthcare company, pioneering new technologies to advance early cancer detection. We have built a multi-disciplinary organization of scientists, engineers, and physicians and we are using the power of next-generation sequencing (NGS), population-scale clinical studies, and state-of-the-art computer science and data science to overcome one of medicine's greatest challenges. GRAIL is headquartered in Menlo Park, California, with locations in Washington, D.C., North Carolina, and the United Kingdom. It is supported by leading global investors and pharmaceutical, technology, and healthcare companies. For more information, please visit grail.com. As part of the Compliance, Operations, Records, and Education (C.O.R.E.) organization, the Quality Systems Specialist will be responsible for supporting 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 person will work cross-functionally to ensure alignment and implementation of QMS programs while adhering to strict project and program timelines and deliverables. This role will be a hands-on resource reporting to the Director, Compliance, Operations, Records, and Education (C.O.R.E. Team)- and will also require routine coordination of other cross-functional needs and initiatives with other Quality colleagues, business stakeholders, and leadership team members. 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. Preferred 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) 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, ISO 13485, IVDR, 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. Expected full time annual base pay scale for this position is $114K - $142K. Actual base pay will consider skills, experience and location. Based on the role, colleagues may be eligible to participate in an annual bonus plan tied to company and individual performance, or an incentive plan. We also offer a long-term incentive plan to align company and colleague success over time. In addition, GRAIL offers a progressive benefit package, including flexible time-off, a 401k with a company match, and alongside our medical, dental, vision plans, carefully selected mindfulness offerings. GRAIL is an Equal Employment 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. We will reasonably accommodate all individuals with disabilities so that they can participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment. Please contact us to request accommodation. GRAIL maintains a drug-free workplace.
    $114k-142k yearly Auto-Apply 60d+ ago
  • Facilities Mechanical Technician (M-F 7AM- 3:30 PM EST) #4371

    Grail 4.2company rating

    Grail job in Raleigh, NC

    Our mission is to detect cancer early, when it can be cured. We 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. We are a healthcare company, pioneering new technologies to advance early cancer detection. We have built a multi-disciplinary organization of scientists, engineers, and physicians and we are using the power of next-generation sequencing (NGS), population-scale clinical studies, and state-of-the-art computer science and data science to overcome one of medicine's greatest challenges. GRAIL is headquartered in Menlo Park, California, with locations in Washington, D.C., North Carolina, and the United Kingdom. It is supported by leading global investors and pharmaceutical, technology, and healthcare companies. For more information, please visit grail.com. The Facilities Mechanical Technician is primarily responsible for maintaining all building, utility and operations equipment. This position is responsible for assisting in the development and coordination of mechanical, controls, and maintenance services to assure equipment reliability. Responsible for maintaining site HVAC systems, Building Automation System (BAS), and other systems supporting 24/7 site operations. The individual will need to collaborate with the rest of the facilities team to ensure Facility Assets (utilities, equipment, and systems) reliability, assist in the spare parts program to maintain inventory levels, and qualify replacement parts. Maintenance activities would include troubleshooting, and preventative and corrective interventions. This position reports to the Facilities Technician Lead. This position will require the use of technical manuals, on-line resources, and OEM representatives to maintain equipment operation with minimum downtime. This position will work with other maintenance and technical trades, contractors, engineers, metrology, validation, and quality to help keep these systems operational while adhering to GxP/ GLP/GMP regulations and quality standards when applicable. Strict adherence to Standard Operating Procedures, Work Instructions, and Quality Standards in a FDA-regulated facility are mandatory. In addition, this individual will also be involved in the installation and start-up of new equipment and assist with any commissioning and qualification activity as required. This position will also support the Environment, Health, and Safety personnel (EHS) to ensure the systems are operated safely and within limits.Responsibilities: Performs and/or coordinates planned and on-demand maintenance activities for Facility Assets (utilities, equipment, and systems), and laboratory operations to ensure 24/7 support. Lead, perform, and optimize the routine Preventive Maintenance (PM) procedures. Perform routine walkthroughs to ensure the Facility Assets (utilities, equipment, and systems) functionality, reliability, and compliance. Operate/ Utilize the Computerized Maintenance Management System (CMMS). Performs and/or coordinates planned and on-demand maintenance activities for Facility Assets (utilities, equipment, and systems) laboratory operations support equipment. Work closely with GRAIL internal stakeholders (for example: Engineering, Department Management, EH&S, etc.) to identify potential failure modes of equipment and maintenance strategies to mitigate impact. Cooperate with the landlord to ensure the property's integrity in the best interest of GRAIL. Oversee, monitor, and respond to Building Automation Systems (BAS) alarms and notifications to support 24/7 operations. Administers maintenance records and coordinates required training to employees and contractors. Document work utilizing the site's CMMS. Develop maintenance Standard Operating Procedure (SOP), Work Instructions (WI), Job Hazard Assessments (JHA), Risk Assessments (RA), job plans, spare parts lists, and other related documentation. Maintain all mandatory training requirements ensuring compliance with site procedures and job performance qualifications. Coordinates with equipment manufacturers, vendors, and support personnel to complete repairs, procure spare parts, and schedule maintenance. Adhere to EH&S guidelines and policies to ensure safe operation of the equipment and systems. Other duties that may reasonably be assigned by management/supervision. Embrace and promote GRAIL's Cultural Values and represent the company properly Preferred Qualifications: Technical Certifications or an Associate's Degree in Mechanical, Electrical, or Applied Engineering is preferred. Equivalent military or similar training is also considered. Industrial or Commercial electrical experience highly preferred Candidate will have a minimum of 7 years of maintenance or operating experience in the Life science industry, preferably in a Clinical Lab (example: CLIA) regulated environment HVAC CFC Certification preferred Working knowledge of Fire Prevention Systems Relative Building Maintenance, General Contractor, Building Operator Certification, etc certifications Working knowledge of MS and/or Google Office products (Word, Excel, Outlook, PowerPoint) Must be able to work in a team-oriented, fast-paced start-up environment. Able to be on a rotating, on-call schedule responding to issues after hours and on weekends/holidays. Maintain a positive, professional, and customer-oriented attitude. Seeks opportunities to implement a mindset of continuous process improvement as related to Facility Assets (utilities, equipment, and systems). Physical Requirements: The ability to regularly lift and/or move up to 50 pounds. Climb ladders and stairs of various heights. This position will include on-call availability for maintenance issues in rotation with other technicians. This position may require coverage of different shifts, weekends and holidays. Expected full time annual base pay scale for this position is $68K-$80K. Actual base pay will consider skills, experience and location. Based on the role, colleagues may be eligible to participate in an annual bonus plan tied to company and individual performance, or an incentive plan. We also offer a long-term incentive plan to align company and colleague success over time. In addition, GRAIL offers a progressive benefit package, including flexible time-off, a 401k with a company match, and alongside our medical, dental, vision plans, carefully selected mindfulness offerings. GRAIL is an Equal Employment 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. We will reasonably accommodate all individuals with disabilities so that they can participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment. Please contact us to request accommodation. GRAIL maintains a drug-free workplace.
    $68k-80k yearly Auto-Apply 60d+ ago
  • Supervisor, Engineering Operations (2nd Shift - Sun, Mon, Tues, Wed, 2:00 PM - 12:00 AM EST) #4265

    Grail 4.2company rating

    Grail job in Durham, NC

    Our mission is to detect cancer early, when it can be cured. We 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. We are a healthcare company, pioneering new technologies to advance early cancer detection. We have built a multi-disciplinary organization of scientists, engineers, and physicians and we are using the power of next-generation sequencing (NGS), population-scale clinical studies, and state-of-the-art computer science and data science to overcome one of medicine's greatest challenges. GRAIL is headquartered in Menlo Park, California, with locations in Washington, D.C., North Carolina, and the United Kingdom. It is supported by leading global investors and pharmaceutical, technology, and healthcare companies. For more information, please visit grail.com. GRAIL is seeking a Supervisor, Tier 2 Engineering Operations, supporting laboratory operations by leading a team of junior engineers in providing timely technical support and maintenance of automation systems, software tools, and lab instrumentation. This role ensures equipment reliability, system uptime, and adherence to quality and safety standards through hands-on troubleshooting, escalation management, and coordination with other technical teams. The ideal candidate has strong technical skills, attention to detail, and experience working in a regulated operations or diagnostics environment. The onsite role requires 4 days a week in Durham, NC (RTP Site) This is a full time position working in our lab 2nd Shift - Sun, Mon, Tues, Wed, 2:00 PM - 12:00 AM ESTThe working hours could be temporarily adjusted due to training, travel, and other events or permanently adjusted based on business needs. This position requires on-call duty and may need to support weekends and holidays.Responsibilities: Leadership & Team Management Supervise day-to-day activities of Tier 1 & 2 support staff across second-shift operations. Train, mentor, and coach junior engineers on both technical troubleshooting and compliance-driven regulatory practices (GLP and GMP). Foster a culture of safety, accountability, continous leanring, continous improvments, and regulatory discipline. Technical Operations & Troubleshooting Provide hands-on support for laboratory/manufacturing instrumentation, automation platforms, and software systems (e.g., liquid handlers, NGS platforms, control software). Coordinate preventive maintenance, calibration, and equipment onboarding validation activities, ensuring alignment with QMS and FDA expectations. Oversee incident triage, root cause analysis, CAPA, and track metrics (recurrence rate, closure time). Regulatory & Change Management Lead the Engineering Operations team through the transition from LDT to FDA-regulated IVD environment, ensuring compliance with 21 CFR Part 820, ISO 13485, and Part 11 requirements. Establish and enforce formal change control processes for equipment modifications, repairs, and software updates. Collaborate with Quality and Regulatory Affairs to validate equipment (IQ/OQ/PQ) and document all maintenance and service activities in a compliant manner. Support FDA inspections, audits, and internal quality reviews by ensuring readiness of maintenance, calibration, and service records. Continuous Improvement & Cross-Functional Collaboration Identify and implement process improvements to optimize lab automation performance and uptime. Partner with R&D, Software, and Quality teams on system changes, new equipment validation, and controlled rollouts. Ensure vendor service activities are integrated into the QMS and supplier qualification processes. Preferred Qualifications: 4+ years of technical experience in engineering operations, automation support, or laboratory systems with BS/BA in Engineering, Life Sciences, or related field (or equivalent). 1+ years in a lead or supervisory role, with proven ability to train and mentor junior staff. Hands-on troubleshooting and repair of lab/manufacturing automation and sequencing systems (Hamilton, Tecan, Illumina, etc.). Familiarity with preventive maintenance, CMMS, EAM, calibration, and documentation practices in regulated environments (cGMP/GLP, CAP, CLIA). Strong communication skills and ability to lead in a cross-functional, fast-paced environment. Willingness to work on-call and support weekends/holidays. Highly Preferred Experience with NGS workflows and Illumina sequencing platforms. Experience with Lean Manufacturing, 6-Sigma, equipment design and improvements. Knowledge of EAM/CMMS systems (Hexagon EAM preferred), LIMS, MES, and automation control software (e.g., Green Button Go). Background in change control, CAPA, and equipment validation (IQ/OQ/PQ). Experience guiding a team or organization through a regulatory transition (e.g., LDT to FDA-approved IVD, ISO 13485 implementation). Basic understanding of IT infrastructure and equipment networking. Physical Demands and Working Environment: Onsite, laboratory/manufacturing-based role requiring standing, walking, crouching, and PPE use. Must frequently lift and/or move up to 25 pounds; occasionally up to 50 pounds. Hours and days may vary depending on operational need Travel up to 10%. Expected full time annual base payscale for this position is $91K -$114K. Actual base pay will consider skills, experience and location. Based on the role, colleagues may be eligible to participate in an annual bonus plan tied to company and individual performance, or an incentive plan. We also offer a long-term incentive plan to align company and colleague success over time. In addition, GRAIL offers a progressive benefit package, including flexible time-off, a 401k with a company match, and alongside our medical, dental, vision plans, carefully selected mindfulness offerings. GRAIL is an Equal Employment 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. We will reasonably accommodate all individuals with disabilities so that they can participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment. Please contact us to request accommodation. GRAIL maintains a drug-free workplace.
    $91k-114k yearly Auto-Apply 60d+ ago
  • GRAIL Galleri Consultant (Clinical Sales - Charlotte/Raleigh) # 4403

    Grail 4.2company rating

    Grail job in Raleigh, NC

    Our mission is to detect cancer early, when it can be cured. We 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. We are a healthcare company, pioneering new technologies to advance early cancer detection. We have built a multi-disciplinary organization of scientists, engineers, and physicians and we are using the power of next-generation sequencing (NGS), population-scale clinical studies, and state-of-the-art computer science and data science to overcome one of medicine's greatest challenges. GRAIL is headquartered in Menlo Park, California, with locations in Washington, D.C., North Carolina, and the United Kingdom. It is supported by leading global investors and pharmaceutical, technology, and healthcare companies. For more information, please visit grail.com . This is a great opportunity to join the growing commercial team at GRAIL, as a GRAIL Galleri Consultant (GGC), working hand in hand with sales leadership and internal stakeholders to execute the go to market sales strategy for GRAIL's revolutionary MCED (multi-cancer early detection) product Galleri. ************************ This is a customer-focused position that requires a "market builder" mindset. A successful GGC acts with urgency and passion to engage physicians and their staff to think differently about cancer screening and change the way they practice, integrating MCED technology into their office workflow, and consistently offering it to appropriate patients with the goal to identify more cancers sooner. GRAIL is the first company in the world to bring MCED technology to patients and clinicians - this is a rare opportunity in one's career! This position is field based and will oversee the Charlotte, NC territory. Candidates must reside within the territory. The GGC role is an in-person selling role, with the expectation that candidates spend the majority of their time (>85%) making in-person visits to targeted physician practices, planning and supporting events, and executing on Company initiatives. Candidates must reside within the territory in one of these locations- Charlotte/Raleigh and surrounding areas. We're building a world-class team to take on one of healthcare's most important challenges. Are you ready to join us? **Responsibilities** + Be part of a best-in-class commercial organization + Report directly to a GRAIL District Manager + Prospect and target primary care practices in your territory to generate interest in Galleri and identify/onboard early adopter customers + Represent a diverse team of professionals to enhance our competitiveness and innovation + Be part of a team and collaborate with internal stakeholders to succeed in creating a new paradigm in cancer screening + Work with executive sales leadership, marketing, customer service, billing, and other customer-facing functions to provide "on the ground" feedback that will help shape our strategies and execution plans + Develop and implement a business plan to support your territory's growth + Demonstrate and leverage a deep understanding of the Laboratory Developed Test (LDT) market, competitive landscape and current cancer screening options, in the effective execution of sales activities and growth + Meet or exceed sales goals by increasing breadth and depth of prescribing, maximize the impact of promotional budgets, and execute the national sales strategy in accordance with GRAIL standards and management expectations. + Identify opportunities in the marketplace, share best practices, and proactively communicate successful selling strategies to peers, management, cross-functional partners, and members of the Commercial Team Manage implementation of all promotional activities to support sales and marketing strategies, in accordance with high industry standards and company policies + Collaborate with Medical Science Liaisons (MSLs) to educate providers on the science and studies that support MCED technology, and build relationships with Key Opinion Leaders. **Required Qualifications** + Bachelor's Degree required + Minimum 8+ years of sales experience within lab, pharmaceutical, or biotechnology industry or 12+ years of overall sales experience including at least 4+ years of recent sales experience within lab, pharmaceutical, or biotechnology industry. + Documented history of sales performance success and accolades; demonstrated strong selling skills and deep understanding of the selling process in the healthcare industry + New product launch experience with a complex, highly technical product - LDT or new product category launch experience is preferred; ability to translate complex science into compelling customer messages that drive action + Working knowledge of geography and customer base; existing relationships with concierge medicine and/or health system providers is preferred + Understanding of environmental and industry trends, and impact on customers + An accomplished track record of driving growth within an owned territory or customer base (as the single point of accountability for performance of a sales territory) + Ability to thrive and deliver value in a complex, cross-functional working environment; ability to build and maintain key internal relationships, drive strategic sales and marketing solutions, execute sales strategy focusing on growth, and tailor solutions to individual customer needs leveraging available resources at GRAIL + Willingness to "roll up your sleeves and build from scratch"; enjoy the unique challenge of creating a new category one customer at a time + Experience working in a startup / high growth environment; comfortable with ambiguity and change + Passion for GRAIL's mission + Advanced business acumen and granular account acumen management skills + Ability to travel as required as needed - approximately 50%. Expected full time annual base pay scale for this position is $114K-$142K. Actual base pay will consider skills, experience and location. Based on the role, colleagues may be eligible to participate in an annual bonus plan tied to company and individual performance, or an incentive plan. We also offer a long-term incentive plan to align company and colleague success over time. In addition, GRAIL offers a competitive benefit package, including flexible time-off, a 401(k) with a company % match, medical, dental, and vision insurance plans, and carefully selected mindfulness offerings, in accordance with our applicable plans and policies. GRAIL is an equal employment opportunity employer, and we are committed to building a workplace where every individual can thrive, contribute, and grow. It is GRAIL policy to provide equal employment opportunities without regard to race, color, religion, national origin, sex, gender, gender identity, sexual orientation, age, marital status, protected veteran status, disability status, medical condition, or any other class or characteristic protected by applicable federal, state, and local laws. This policy applies to all phases of employment, including, but not limited to: recruiting, hiring, training, promotion, and termination at all levels of employment. GRAIL maintains a drug-free workplace. Additionally, GRAIL will consider all qualified job-seekers with criminal histories in a manner consistent with applicable law and provide reasonable accommodations to qualified individuals with disabilities so that they can participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment. Please contact us at *************** if you require an accommodation to apply for an open position. For more information about equal employment opportunity protections, please view the 'Know Your Rights (**************************** ' poster. We welcome job-seekers from all backgrounds to join us!
    $114k-142k yearly 60d ago
  • Senior Scientist Technical Operations # 4375

    Grail 4.2company rating

    Grail job in Durham, NC

    Our mission is to detect cancer early, when it can be cured. We 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. We are a healthcare company, pioneering new technologies to advance early cancer detection. We have built a multi-disciplinary organization of scientists, engineers, and physicians and we are using the power of next-generation sequencing (NGS), population-scale clinical studies, and state-of-the-art computer science and data science to overcome one of medicine's greatest challenges. GRAIL is headquartered in Menlo Park, California, with locations in Washington, D.C., North Carolina, and the United Kingdom. It is supported by leading global investors and pharmaceutical, technology, and healthcare companies. For more information, please visit grail.com. The Senior Scientist, Technical Operations is responsible for supporting sustaining operations and introducing new assays and diagnostic products into GRAIL's high‑throughput, regulated laboratory environment. This individual contributor partners closely with MSAT, Assay Development, Engineering Operations, and the Clinical Lab to lead process integration, improvement, monitoring, and troubleshooting. The ideal candidate brings deep expertise across the end‑to‑end laboratory workflow-from pre‑analytical through post‑analytical-strong process optimization experience, and a thorough understanding of clinical laboratory regulatory frameworks. This position is onsite full-time, with 5 days per week at our facility. Additionally, the role requires participation in a rotating schedule for weekend and holiday coverage (when applicable), as part of ensuring continuous support for critical laboratory operations.Responsibilities: Lead or assist in process troubleshooting activities, including root-cause analysis and impact assessments, resolving technical challenges. Monitor process performance, analyze data and metrics, and contribute to process monitoring and improvement strategies to sustain high-quality, efficient operations. Support the transfer and implementation of new assays and diagnostic products from development into production, ensuring robust performance across all workflow phases. Develop, optimize, and document validation protocols and procedures in compliance with CLIA, CAP, NYS, ISO 13485, FDA, and other applicable standards. Provide scientific and technical support to MSAT, Engineering Operations, and Clinical Lab teams. Evaluate, qualify, and implement alternative reagents and vendors to maintain continuity and strengthen lab operations. Identify process gaps and contribute to or lead process improvement initiatives to enhance efficiency, reliability, and quality. Prepare comprehensive technical documentation, scientific reports, and regulatory submission materials as required. Maintain high standards of scientific rigor, quality, and regulatory compliance in all process integration activities. Lead complex investigations and root-cause analyses; implement effective CAPAs and preventive measures with clear verification of effectiveness Support lab readiness: training, tech transfer materials, troubleshooting guides, and operational playbooks for Clinical Lab teams Analyze complex datasets and present insights to technical and non-technical stakeholders to guide decisions Contribute to inspection/audit readiness and support interactions with CAP/CLIA, state agencies (e.g., NYS), and other regulatory bodies as needed Required Qualifications: PhD in Life Sciences, Molecular Biology, Biochemistry, Bioengineering, or a related field. Proven experience in technology transfer of assays and launching new products in a regulated diagnostic laboratory. Direct, hands-on experience with end-to-end clinical workflows (pre-analytical, analytical, and post-analytical). Strong knowledge of high-throughput laboratory automation and advanced instrumentation. Deep understanding of clinical laboratory regulatory standards, including CLIA, CAP, NYS, ISO 13485, and FDA. Experience with or understanding of reagent manufacturing and alternative vendor qualification processes. Experience participating in audits (internal, regulatory, or client-driven). Excellent skills in technical documentation and scientific writing. Demonstrated ability to collaborate effectively across MSAT, Engineering Operations, and Clinical Lab teams. Six Sigma certification or significant experience with Lean, Kaizen, or other process improvement methodologies. Hands-on experience with data analytics tools and platforms (e.g., JMP, Minitab, R, Python, Tableau) for process monitoring, analysis, and reporting. Experience with laboratory information management systems (LIMS) or MES. Advanced data analysis skills applied to laboratory operations and quality improvement. Experience supporting laboratory scale-up, automation, or operational excellence projects. Expected full time annual base pay scale for this position is $119K - $142K. Actual base pay will consider skills, experience and location. Based on the role, colleagues may be eligible to participate in an annual bonus plan tied to company and individual performance, or an incentive plan. We also offer a long-term incentive plan to align company and colleague success over time. In addition, GRAIL offers a competitive benefit package, including flexible time-off, a 401(k) with a company % match, medical, dental, and vision insurance plans, and carefully selected mindfulness offerings, in accordance with our applicable plans and policies. GRAIL is an equal employment opportunity employer, and we are committed to building a workplace where every individual can thrive, contribute, and grow. It is GRAIL policy to provide equal employment opportunities without regard to race, color, religion, national origin, sex, gender, gender identity, sexual orientation, age, marital status, protected veteran status, disability status, medical condition, or any other class or characteristic protected by applicable federal, state, and local laws. This policy applies to all phases of employment, including, but not limited to: recruiting, hiring, training, promotion, and termination at all levels of employment. GRAIL maintains a drug-free workplace. Additionally, GRAIL will consider all qualified job-seekers with criminal histories in a manner consistent with applicable law and provide reasonable accommodations to qualified individuals with disabilities so that they can participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment. Please contact us at *************** if you require an accommodation to apply for an open position. For more information about equal employment opportunity protections, please view the 'Know Your Rights' poster. We welcome job-seekers from all backgrounds to join us!
    $119k-142k yearly Auto-Apply 53d ago
  • Supervisor Accessioning, CLIA Laboratory # 4392 (Tuesday - Saturday 9:30am - 6pm)

    Grail 4.2company rating

    Grail job in Durham, NC

    Our mission is to detect cancer early, when it can be cured. We 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. We are a healthcare company, pioneering new technologies to advance early cancer detection. We have built a multi-disciplinary organization of scientists, engineers, and physicians and we are using the power of next-generation sequencing (NGS), population-scale clinical studies, and state-of-the-art computer science and data science to overcome one of medicine's greatest challenges. GRAIL is headquartered in Menlo Park, California, with locations in Washington, D.C., North Carolina, and the United Kingdom. It is supported by leading global investors and pharmaceutical, technology, and healthcare companies. For more information, please visit grail.com. The Supervisor, Accessioning is responsible for the general supervision of Accessioning Clinical Laboratory personnel and the daily operations of the Pre-Analytical Laboratory. The nature of the work requires excellent attention to detail, effective written and verbal communication skills, the ability to multitask and be flexible with tasks and schedules, and the ability to work independently and in a team environment!Responsibilities: Provide day-to-day supervision of laboratory personnel and participate in daily Accessioning work as needed. Be responsible for the daily pre-analytical operations of the laboratory including but not limited to scheduling, independently troubleshooting and resolving technical and non-technical high complexity problems. Independently identify and troubleshoot high complexity problems that would adversely affect test performance. Perform administrative duties including but not limited to writing employee performance evaluations and reviewing SOPs, protocols, QC forms, and equipment maintenance forms. Coach and mentor Laboratory Assistants including but not limited to providing guidance and constructive feedback and assisting with the development of troubleshooting and judgment. Collaborate with the product development and software engineering teams to enhance the LIMS capabilities for accuracy and scale. Streamline existing workflows and laboratory space to enable high-throughput processes and high accessioning volume. Perform, review and document laboratory quality control procedures, as needed. Operate, maintain, and troubleshoot laboratory equipment, as needed. Coordinate the training of new laboratory personnel and training of new procedures with existing personnel. Participate in quality assurance activities. Effectively communicate technical information to technical and non-technical audiences. Maintain stringent standards for quality, identifying any issues which might adversely impact the quality of test results and/or employee safety, and presenting these to the appropriate management representatives as vital for resolution. Report all concerns of test quality and/or safety to the Supervisor or Safety Officer. Required Qualifications: Bachelor of Science, or an equivalent combination of training and experience. Working knowledge of local, state, and federal laboratory regulations. At least three years of CAP/CLIA certified Laboratory Supervisory experience or equivalent. Exceptional understanding of CAP, CLIA and NYSDOH regulations. Strong communicator with ability to maintain open communication with internal employees, managers and customers as needed. Able to integrate and apply feedback in a professional manner. Able to prioritize and drive to results with a high emphasis on quality. Ability to work as part of a team Physical Demands and Working Environment Hours and days may vary depending on operational needs. Standing or sitting for long periods of time may be necessary. May be exposed to hazardous materials, blood specimens and instruments with moving parts, heating or freezing elements, and high speed centrifugation. Work on nights, weekends, and holidays may be required. The expected, full-time, annual base pay scale for this position is $78K - $97K in Durham, NC. Actual base pay will consider skills, experience, and location. Based on the role, colleagues may be eligible to participate in an annual bonus plan tied to company and individual performance, or an incentive plan. We also offer a long-term incentive plan to align company and colleague success over time. In addition, GRAIL offers a competitive benefit package, including flexible time-off, a 401(k) with a company % match, medical, dental, and vision insurance plans, and carefully selected mindfulness offerings, in accordance with our applicable plans and policies. GRAIL is an equal employment opportunity employer, and we are committed to building a workplace where every individual can thrive, contribute, and grow. It is GRAIL policy to provide equal employment opportunities without regard to race, color, religion, national origin, sex, gender, gender identity, sexual orientation, age, marital status, protected veteran status, disability status, medical condition, or any other class or characteristic protected by applicable federal, state, and local laws. This policy applies to all phases of employment, including, but not limited to: recruiting, hiring, training, promotion, and termination at all levels of employment. GRAIL maintains a drug-free workplace. Additionally, GRAIL will consider all qualified job-seekers with criminal histories in a manner consistent with applicable law and provide reasonable accommodations to qualified individuals with disabilities so that they can participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment. Please contact us at *************** if you require an accommodation to apply for an open position. For more information about equal employment opportunity protections, please view the 'Know Your Rights' poster. We welcome job-seekers from all backgrounds to join us!
    $78k-97k yearly Auto-Apply 55d ago
  • Staff Data Engineer (Menlo Park, CA ) #4433

    Grail 4.2company rating

    Grail job in Durham, NC

    Our mission is to detect cancer early, when it can be cured. We 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. We are a healthcare company, pioneering new technologies to advance early cancer detection. We have built a multi-disciplinary organization of scientists, engineers, and physicians and we are using the power of next-generation sequencing (NGS), population-scale clinical studies, and state-of-the-art computer science and data science to overcome one of medicine's greatest challenges. GRAIL is headquartered in Menlo Park, California, with locations in Washington, D.C., North Carolina, and the United Kingdom. It is supported by leading global investors and pharmaceutical, technology, and healthcare companies. For more information, please visit grail.com. We design, optimize, and manage GRAIL's end-to-end data lifecycle, from sample ingestion through analysis, ensuring every step meets rigorous regulatory and clinical standards. We are seeking a Staff Software Engineer to help deliver the high-quality datasets that power research, analytics, and scientific insights. In this role, you will collaborate with cross-functional teams to deliver scalable data solutions aligned with FDA and global health authority requirements.Our ideal candidate brings experience in the life sciences and a strong background in data processing, infrastructure and operational excellence. This role is based in Menlo Park, California, and will move to Sunnyvale, California in Fall 2026. It offers a flexible work arrangement, with the ability to work from GRAIL's office or from home. Our current flexible work arrangement policy requires that a minimum of 60%, or 24 hours, of your total work week be on-site. Your specific schedule, determined in collaboration with your manager, will align with team and business needs and could exceed the 40% requirement for the site. At our Menlo Park campus, Tuesdays and Thursdays are the key days where we encourage on-site presence to engage in events and on-site activities.Responsibilities Contribute to a highly collaborative team focused on delivering value to cross-functional partners by implementing processes and tools that prepare analysis-ready datasets. Integrate inputs from diverse data sources across the organization into well-structured, harmonized datasets. Build and maintain access controls and data-delivery mechanisms that uphold stringent blinding and privacy standards. Partner with Research, Clinical Lab Operations, and Software Engineering teams to define and implement data transformations that support downstream analysis. Ensure all delivered data adheres to software quality expectations, clinical compliance requirements, sequestration protocols, and privacy regulations. Implement automated testing and release processes to improve the reliability, quality, and velocity of software and data deliveries. Mentor engineers and scientists, promoting best practices in software development, data engineering, and operational rigor. Preferred Qualifications BS/MS/PhD in a quantitative field (e.g., Computer Science, Engineering, Mathematics, Statistics, Bioinformatics) or equivalent and 6+ years of experience in data engineering, ideally within a regulated biotechnology, pharmaceutical, medical device, or healthcare environment. Deep knowledge of ETL/ELT workflows, data pipeline development, and database management, with demonstrated success delivering data solutions for clinical or regulatory use cases. Expertise in SQL and proficiency in Go and Python. Experience with R would be nice to have. Experience with cloud-based data platforms (AWS, Azure, or Google Cloud) and preferably an understanding of compliance frameworks such as HIPAA and GDPR. Strong analytical and problem-solving skills, with a track record of maintaining data quality and integrity across complex datasets. Proven experience working on cross-functional teams and translating user requirements into scalable, high-quality data solutions. Hands-on experience with relational databases, data modeling, data pipeline tools, and workflow engines (e.g., SQL, dbt, Apache Airflow, AWS Glue, Spark). Familiarity with DevOps practices, including CI/CD pipelines, containerized deployment (e.g., Kubernetes), and infrastructure-as-code (e.g., Terraform). Ability to navigate ambiguity, refine evolving requirements, and work with product and stakeholder teams to drive clear engineering objectives and designs. Excellent written and verbal communication skills, with the ability to tailor technical content to diverse audiences. Expected full time annual base pay scale for the bay area is $163K-$216K. Actual base pay will consider skills, experience and location. Based on the role, colleagues may be eligible to participate in an annual bonus plan tied to company and individual performance, or an incentive plan. We also offer a long-term incentive plan to align company and colleague success over time. In addition, GRAIL offers a competitive benefit package, including flexible time-off, a 401(k) with a company % match, medical, dental, and vision insurance plans, and carefully selected mindfulness offerings, in accordance with our applicable plans and policies. GRAIL is an equal employment opportunity employer, and we are committed to building a workplace where every individual can thrive, contribute, and grow. It is GRAIL policy to provide equal employment opportunities without regard to race, color, religion, national origin, sex, gender, gender identity, sexual orientation, age, marital status, protected veteran status, disability status, medical condition, or any other class or characteristic protected by applicable federal, state, and local laws. This policy applies to all phases of employment, including, but not limited to: recruiting, hiring, training, promotion, and termination at all levels of employment. GRAIL maintains a drug-free workplace. Additionally, GRAIL will consider all qualified job-seekers with criminal histories in a manner consistent with applicable law and provide reasonable accommodations to qualified individuals with disabilities so that they can participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment. Please contact us at *************** if you require an accommodation to apply for an open position. For more information about equal employment opportunity protections, please view the 'Know Your Rights' poster. We welcome job-seekers from all backgrounds to join us!
    $163k-216k yearly Auto-Apply 38d ago
  • Senior Quality Specialist - CAPA # 4408

    Grail 4.2company rating

    Grail job in Durham, NC

    Our mission is to detect cancer early, when it can be cured. We 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. We are a healthcare company, pioneering new technologies to advance early cancer detection. We have built a multi-disciplinary organization of scientists, engineers, and physicians and we are using the power of next-generation sequencing (NGS), population-scale clinical studies, and state-of-the-art computer science and data science to overcome one of medicine's greatest challenges. GRAIL is headquartered in Menlo Park, California, with locations in Washington, D.C., North Carolina, and the United Kingdom. It is supported by leading global investors and pharmaceutical, technology, and healthcare companies. For more information, please visit grail.com. Reporting to the Senior Director, Quality Strategy & Operational Excellence, the Senior Quality Specialist is responsible for executing, maintaining, and improving key Quality Management System (QMS) processes including Corrective and Preventive Action (CAPA) investigations, Nonconformance (NCR) reporting, Quality Management Review (QMR), clinical laboratory Quality Monitoring and Improvement (QMI), and Quality Indices (QI). This role also supports Change Control, Quality Planning, clinical laboratory licensure/certification, internal and external audits, and other activities as assigned. This person will work cross-functionally to ensure alignment and implementation of QMS programs while adhering to strict project and program timelines and deliverables. The person in this role consistently applies critical thinking skills and good judgment to solve complex problems, effectively communicating status and recommendations to management. This role is based at our Durham, North Carolina, office and offers a flexible working arrangement. It offers a flexible work arrangement, with the ability to work from GRAIL's office or from home. Our current flexible work arrangement policy requires that a minimum of 60%, or 24 hours, of your total work week be on-site. Your specific schedule, determined in collaboration with your manager, will align with team and business needs and could exceed the 60% requirement for the site.Responsibilities: Facilitate and coordinate the CAPA program, NCR program, quality metrics, and quality planning process. Maintain and improve these programs in compliance with GRAIL's Quality Management System procedures and regulatory requirements including ISO 13485, ISO 14971, 21 CFR 820, IVDR, CAP/CLIA/NYSDOH, ISO 15189, and related regulations and standards. Lead regularly scheduled meetings to ensure timely and compliant completion of Nonconformance reports (NCRs), obtaining and communicating status and escalating effectively as needed to obtain executive awareness and support. Coordinate the CAPA Review Board, ensuring timely and compliant completion of CAPAs, obtaining and communicating status and escalating effectively as needed to obtain executive awareness and support. Coordinate generation and analysis of monthly Quality Indices reports (quality metrics) as part of Measurement, Analysis, and Improvement activities, rolling up into medical device QMR and clinical laboratory QMI meetings. Facilitate quality planning activities including optimizing planning tools, workflows, and documentation, and obtaining and communicating status, escalating effectively as needed to obtain executive awareness and support. Respond to process and software system-related inquiries and maintain effective cross-functional team communications to advance GRAIL's quality activities and promote compliant and standard process execution. Maintain, improve, and facilitate training and competency programs for the CAPA and NCR processes. Lead software system configuration maintenance and improvements, including testing and validation, updating documents (SOPs, reports, protocols, specifications, etc.), as well as documenting, assessing, and resolving feedback to improve the end user experience. Cultivate positive relationships with cross-functional partners, leadership team members, and personnel executing and supporting these processes. Assess unusual circumstances and use sophisticated analytical and problem solving techniques to identify causes. Proactively resolve a wide range of issues in creative and compliant ways. Demonstrate technical proficiency, creativity, teamwork, collaboration with others, and regular independent thought. Exercise good judgment within broadly defined practices and policies in selecting methods, techniques, and evaluation criteria for obtaining results. Act independently with regular oversight to determine methods and procedures to successfully complete assignments. Structure day-to-day work autonomously, effectively communicating status and issues with management. Participate in preparation for and execution of internal and external audits and inspections. Support timely and compliant responses to observations. Provide guidance to other departments and serve as subject matter expert (SME) on applicable regulations and standards. Perform other duties as assigned by management. Required Qualifications: Bachelor's degree in science, engineering, or other technical area.8+ years of related experience (Masters 5+ years) working within a medical device, pharmaceutical, or biotech QMS, with expertise in CAPA, NCR, and metrics reporting. Demonstrated knowledge and understanding of applicable regulations and standards, including but not limited to QSR, ISO 13485, CAP/CLIA, NYSDOH, ISO 15189, IVDR. Experience using an eQMS required; Veeva Vault 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. Experience supporting regulatory inspections/audits and responding to findings. Excellent written and verbal communication skills. Expertise managing data reporting and communications using tools including Smartsheet, Confluence, Google Docs and Google Slides. ASQ Certified Quality Auditor, Certified Quality Engineer, or similar. Expected full time annual base pay scale for this position is $91,000 - $121,000. Actual base pay will consider skills, experience and location. Based on the role, colleagues may be eligible to participate in an annual bonus plan tied to company and individual performance, or an incentive plan. We also offer a long-term incentive plan to align company and colleague success over time. In addition, GRAIL offers a competitive benefit package, including flexible time-off, a 401(k) with a company % match, medical, dental, and vision insurance plans, and carefully selected mindfulness offerings, in accordance with our applicable plans and policies. GRAIL is an equal employment opportunity employer, and we are committed to building a workplace where every individual can thrive, contribute, and grow. It is GRAIL policy to provide equal employment opportunities without regard to race, color, religion, national origin, sex, gender, gender identity, sexual orientation, age, marital status, protected veteran status, disability status, medical condition, or any other class or characteristic protected by applicable federal, state, and local laws. This policy applies to all phases of employment, including, but not limited to: recruiting, hiring, training, promotion, and termination at all levels of employment. GRAIL maintains a drug-free workplace. Additionally, GRAIL will consider all qualified job-seekers with criminal histories in a manner consistent with applicable law and provide reasonable accommodations to qualified individuals with disabilities so that they can participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment. Please contact us at *************** if you require an accommodation to apply for an open position. For more information about equal employment opportunity protections, please view the 'Know Your Rights' poster. We welcome job-seekers from all backgrounds to join us!
    $91k-121k yearly Auto-Apply 33d ago
  • Regulatory Affairs Associate Director, IVD # 4432

    Grail 4.2company rating

    Grail job in Durham, NC

    Our mission is to detect cancer early, when it can be cured. We 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. We are a healthcare company, pioneering new technologies to advance early cancer detection. We have built a multi-disciplinary organization of scientists, engineers, and physicians and we are using the power of next-generation sequencing (NGS), population-scale clinical studies, and state-of-the-art computer science and data science to overcome one of medicine's greatest challenges. GRAIL is headquartered in Menlo Park, California, with locations in Washington, D.C., North Carolina, and the United Kingdom. It is supported by leading global investors and pharmaceutical, technology, and healthcare companies. For more information, please visit grail.com . The role assists with regulatory strategy and the development of submissions in partnership with key internal and external stakeholders for GRAIL projects, including Multi-Cancer Early Detection (MCED). The position supports the U.S. Regulatory team in preparing Investigational Device Exemptions (IDEs), IDE supplements, pre-submissions, Premarket Approvals (PMAs), annual reports, and other relevant documentation. The role collaborates cross-functionally with Quality, Lab Operations, and other stakeholders to support regulatory strategy development, product validation, audits, promotional material review, on-market product support, and change control processes. This individual monitors and communicates changes in regulatory policies and In Vitro Diagnostic (IVD) requirements to project teams and leadership. They may manage and provide direction to regulatory staff and, when required, participate in senior management meetings as a delegate. The role fosters a work culture aligned with GRAIL's values This job requires that a minimum of 60% or 3 days of the total work week be onsite in Durham, NC. **Responsibilities:** + Strategize, plan, and author regulatory plans and activities to optimally position GRAIL products with the FDA and/or global health authorities. + Support the U.S. Regulatory Affairs team in preparing submissions such as PMAs, 510(k)s, post-approval reports, annual reports, export certificates, establishment registrations, and device listings. + Serve as a key member of the Regulatory team, offering insights and solutions on corporate product portfolios and strategies. + Provide regulatory support for both new and marketed Laboratory Developed Test (LDT) products, including labeling, promotional materials, product changes, and documentation required for compliance and regulatory approval. + Monitor and report on international regulatory developments and LDT requirements that may significantly impact business operations or customers. + Maintain up-to-date knowledge of applicable regulatory requirements and relevant scientific/technical developments. + Identify regulatory risks and propose alternative courses of action. + Assess new regulations and collaborate with internal teams to implement appropriate changes. + Support internal and external quality audits. + Ensure compliance with all regulations and laws applicable to GRAIL's business, providing guidance and recommendations. + Review and approve regulatory strategy documents, regulatory plans, procedures, SOPs, and other documents for alignment with commitments, regulations, and filings. + Manage the creation and review of Standard Operating Procedures and policy guidelines within the regulatory affairs department. + Perform other duties as assigned. **Required Qualifications:** + **Experience** + Minimum of 10 years of experience in regulatory, development, clinical affairs, quality, or program management within the IVD, medical device, or pharmaceutical industries. + Regulatory affairs and IVD device experience preferred. + An advanced degree may count toward years of experience. + Direct experience with FDA regulatory submissions required. + Experience with regulatory submissions in the EU, Japan, China, Canada, and other international markets is preferred. + Background in diagnostics or biomarker development, particularly in oncology, is a plus. + Advanced scientific degree preferred. + Regulatory Affairs Certification (RAC) preferred. + Experience in pharmaceutical clinical, statistical, or regulatory settings-especially in oncology, immunology, or related fields-is a plus. **Knowledge, Skills, and Abilities** + Proven leadership and sound judgment with strong business partnering skills. + Demonstrated knowledge of U.S. and international regulatory frameworks and processes for medical device development and approvals. + Effective collaborator in dynamic, fast-paced, and evolving environments. + Problem-solving mindset with the ability to work well across diverse teams. + Strong written and verbal communication skills. + Excellent organizational skills and attention to detail. Expected full time annual base pay scale for this position is $164K-$205K. Actual base pay will consider skills, experience and location. Based on the role, colleagues may be eligible to participate in an annual bonus plan tied to company and individual performance, or an incentive plan. We also offer a long-term incentive plan to align company and colleague success over time. In addition, GRAIL offers a competitive benefit package, including flexible time-off, a 401(k) with a company % match, medical, dental, and vision insurance plans, and carefully selected mindfulness offerings, in accordance with our applicable plans and policies. GRAIL is an equal employment opportunity employer, and we are committed to building a workplace where every individual can thrive, contribute, and grow. It is GRAIL policy to provide equal employment opportunities without regard to race, color, religion, national origin, sex, gender, gender identity, sexual orientation, age, marital status, protected veteran status, disability status, medical condition, or any other class or characteristic protected by applicable federal, state, and local laws. This policy applies to all phases of employment, including, but not limited to: recruiting, hiring, training, promotion, and termination at all levels of employment. GRAIL maintains a drug-free workplace. Additionally, GRAIL will consider all qualified job-seekers with criminal histories in a manner consistent with applicable law and provide reasonable accommodations to qualified individuals with disabilities so that they can participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment. Please contact us at *************** if you require an accommodation to apply for an open position. For more information about equal employment opportunity protections, please view the 'Know Your Rights (**************************** ' poster. We welcome job-seekers from all backgrounds to join us!
    $53k-75k yearly est. 20d ago
  • Director, People Business Partner #4428

    Grail 4.2company rating

    Grail job in Durham, NC

    Our mission is to detect cancer early, when it can be cured. We 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. We are a healthcare company, pioneering new technologies to advance early cancer detection. We have built a multi-disciplinary organization of scientists, engineers, and physicians and we are using the power of next-generation sequencing (NGS), population-scale clinical studies, and state-of-the-art computer science and data science to overcome one of medicine's greatest challenges. GRAIL is headquartered in Menlo Park, California, with locations in Washington, D.C., North Carolina, and the United Kingdom. It is supported by leading global investors and pharmaceutical, technology, and healthcare companies. For more information, please visit grail.com. We are seeking an experienced People Business Partner, Director to join our team in North Carolina's premier global innovation center, Research Triangle Park (RTP), supporting our Development and Operations functions at our flagship laboratory. You will also serve as the HR leader for RTP, playing a critical role in shaping the culture, aligning local execution with broader corporate strategy, and creating an environment where people and teams can thrive. This role is requiring onsite presence at least 4 days a week, with occasional travel to our California headquarters. Responsibilities Partner closely with the SVP of Development and Operations (based in Menlo Park) and the VP of Operations (based in RTP) as a trusted advisor on people and organizational matters, helping to shape and execute the people strategy that supports team effectiveness, culture, and business goals. Design and implement organizational structures that scale with business growth, driving clarity, effectiveness, and accountability. Guide leaders and employees through organizational changes, ensuring effective communication and support during transitions. Drive change management initiatives that help teams adapt and thrive in a dynamic environment, partnering with leaders to develop and implement effective communication plans that support clarity, alignment, and engagement. Solve complex employee relations (ER) issues with fairness, legal compliance, and thoughtful care. Guide leaders on performance management, development, coaching, compensation, team, and organizational effectiveness initiatives. Facilitate and drive all core people programs, including performance reviews, calibrations, compensation planning, engagement surveys, succession planning, talent reviews, and workforce planning. Build trusted relationships across all levels to foster stronger collaboration and enhance employee engagement. Utilize HR data and analytics to deliver actionable insights and inform evidence-based decision-making. Collaborate with Centers of Excellence (Talent Acquisition, Total Rewards, Culture & Community, Legal, People Ops) to deliver integrated, scalable people programs. Support employees in both exempt and non-exempt roles with tailored HR strategies. Collaborate with the Site Lead, Facilities, Safety, Security, IT, and Site Operations to maintain a safe, inclusive, and engaging workplace while ensuring compliance with employment, policy, and health & safety standards. Partner on site-wide initiatives such as safety drills, training, and audits through an HR lens that promotes communication, readiness, and employee engagement. Embed the company's mission, vision, and values into daily employee experiences by modeling ethical behavior, accountability, and inclusion across the RTP sit e. Foster community and belonging through engagement programs, culture-building events, and open communication channels such as town halls and feedback sessions that amplify the employee voice. Required Qualifications 15+ years of progressive People Partner experience, including direct support of lab operations, consisting of employees in both exempt and non-exempt roles; currently operating at a Director level or equivalent. Proven success in influencing and advising senior leaders, especially during organizational shifts or transformations. Strong project management skills with a proven ability to develop, lead, and oversee cross-functional initiatives from concept through execution. Deep experience with change management, organizational design, and enabling leadership effectiveness. Skilled in coaching and development of people managers and leadership teams. Strong understanding of employee relations, HR compliance, and employment law, with the ability to manage complex employee relations matters and drive timely, thoughtful resolutions. Skilled at coaching managers through sensitive issues and helping them navigate challenges with confidence and empathy. Experience supporting operations, technical, scientific, or life sciences teams is highly preferred. Ability to balance strategic thinking with operational execution-no task is too big or too small. Proficiency with people analytics and tools like Google Sheets, Slides, or HRIS platforms. High emotional intelligence, integrity, and a growth mindset. Bachelor's degree required; advanced degree or HR certifications are a plus. A collaborative, big-picture thinker who can also operationalize strategy effectively. Demonstrated ability to diagnose organizational challenges and implement scalable solutions. Comfortable working in agile, matrixed environments with shifting priorities. Passion for mission-driven work and building a culture where people can thrive. The expected, full-time, annual base pay scale for this position is $167K-$239K. Actual base pay will consider skills, experience, and location. Based on the role, colleagues may be eligible to participate in an annual bonus plan tied to company and individual performance, or an incentive plan. We also offer a long-term incentive plan to align company and colleague success over time. In addition, GRAIL offers a competitive benefit package, including flexible time-off, a 401(k) with a company % match, medical, dental, and vision insurance plans, and carefully selected mindfulness offerings, in accordance with our applicable plans and policies. GRAIL is an equal employment opportunity employer, and we are committed to building a workplace where every individual can thrive, contribute, and grow. It is GRAIL policy to provide equal employment opportunities without regard to race, color, religion, national origin, sex, gender, gender identity, sexual orientation, age, marital status, protected veteran status, disability status, medical condition, or any other class or characteristic protected by applicable federal, state, and local laws. This policy applies to all phases of employment, including, but not limited to: recruiting, hiring, training, promotion, and termination at all levels of employment. GRAIL maintains a drug-free workplace. Additionally, GRAIL will consider all qualified job-seekers with criminal histories in a manner consistent with applicable law and provide reasonable accommodations to qualified individuals with disabilities so that they can participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment. Please contact us at *************** if you require an accommodation to apply for an open position. For more information about equal employment opportunity protections, please view the 'Know Your Rights' poster. We welcome job-seekers from all backgrounds to join us!
    $64k-107k yearly est. Auto-Apply 46d ago
  • Associate Director Clinical Compliance # 4333 (Durham, NC)

    Grail 4.2company rating

    Grail job in Durham, NC

    Our mission is to detect cancer early, when it can be cured. We 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. We are a healthcare company, pioneering new technologies to advance early cancer detection. We have built a multi-disciplinary organization of scientists, engineers, and physicians and we are using the power of next-generation sequencing (NGS), population-scale clinical studies, and state-of-the-art computer science and data science to overcome one of medicine's greatest challenges. GRAIL is headquartered in Menlo Park, California, with locations in Washington, D.C., North Carolina, and the United Kingdom. It is supported by leading global investors and pharmaceutical, technology, and healthcare companies. For more information, please visit grail.com. Grail's Clinical Compliance department is seeking a compliance expert to support compliant conduct of Grail's clinical studies and to support Grail's partnerships with pharmaceutical companies for companion diagnostic (CDx) tests. The Associate Director, Clinical Compliance will play a key leadership role in shaping and strengthening Grail's Clinical Quality Management System (CQMS) and advancing clinical compliance oversight across clinical studies and companion diagnostic (CDx) development. In this highly visible role, you'll collaborate cross-functionally to proactively manage both GCP and CDx regulatory risks, lead inspection readiness, and continuously improve quality standards utilizing insights from inspections, audits, and evolving regulatory landscapes.Responsibilities: Lead and manage internal processes and systems, clinical and diagnostic quality audits, as well as investigator sites and service provider audits and gap assessments. Identify areas of compliance vulnerability in both clinical and CDx pipelines, develop and drive corrective/preventive action plans, and track clinical compliance-related metrics for senior leadership. Provide routine clinical compliance support to clinical study, and CDx project teams, ensuring adherence to ICH E6 (GCP), relevant diagnostic regulations, and internal quality standards. Support and, where necessary, lead risk assessment and mitigation strategies for clinical studies and CDx programs. Lead and continuously refine the organization's inspection readiness framework for clinical studies and companion diagnostic development, spanning global and regional regulatory inspections (e.g., BIMO, pre-approval, GCP, CLIA, IVDR). Conduct inspection readiness training and coaching sessions Serve as the primary point of contact for hosting inspections/audits, drafting and tracking responses to findings, driving resolution, and leading post-inspection lessons-learned initiatives. Revise, develop, and maintain procedures within the Clinical Quality Management System, leveraging lessons from inspections, audits, and emerging clinical compliance trends, in both GCP and CDx domains. Contribute to, implement, and continuously improve quality management policies and processes related to clinical studies, laboratory-developed tests, and companion diagnostic programs. Own and maintain GCP audit program SOPs and templates, ensuring they remain current with evolving regulatory requirements and industry best practices. Review and provide compliance advice on SOPs, processes, and protocols for both clinical trial and companion diagnostic activities, ensuring consistency and compliance with relevant GCP, CLIA, FDA/IVDR, and other global diagnostic regulatory requirements. Serve as a resource and subject matter expert on clinical and companion diagnostic regulatory standards and best practices. Provide leadership, expertise, and guidance in clinical and companion diagnostic compliance to internal and external stakeholders. Promote a culture of quality and clinical compliance, proactively identifying compliance risks and embedding best practices into organizational processes. Collaborate with cross-functional teams (e.g., Regulatory, Quality Assurance, Lab Operations, Clinical Data Management, etc.), and senior leaders to establish inspection norms and foster continuous improvement. Preferred Qualifications: Bachelor's degree or higher in a scientific, health, quality, or regulatory discipline (advanced degree preferred) 10 + years relevant experience in clinical quality assurance, diagnostics, and/or regulatory compliance within the diagnostics, or medical device field. Experience supporting regulatory inspections such as BIMO. Demonstrated experience managing GCP and/or CDx inspection and audit preparation and response. Expert knowledge of applicable regulations and standards as they relate to clinical trial conduct Understanding of appropriate global medical device/IVD requirements, such as: ICH E6 (GCP), European Union (ISO 20916, ISO 14155, IVDD/IVDR), US [21 CFR Part 812 and Part 11]. Experience managing GCP quality processes such as managing Quality Events and CAPAs; and participating in risk management activities. Conducting GCP audits of internal processes, clinical investigator sites, and clinical service vendors. Demonstrated ability to initiate process improvements and take initiative. Strong influencing skills, with the ability to work collaboratively and cross functionally, within a constantly evolving fast-paced startup environment. Ability to drive and manage change with a positive approach. Travel of up to 20% The expected, full-time, annual base pay scale for this position is 142K - 178K for Durham, NC. Actual base pay will consider skills, experience, and location. Based on the role, colleagues may be eligible to participate in an annual bonus plan tied to company and individual performance, or an incentive plan. We also offer a long-term incentive plan to align company and colleague success over time. In addition, GRAIL offers a progressive benefit package, including flexible time-off, a 401k with a company match, and alongside our medical, dental, vision plans, carefully selected mindfulness offerings. GRAIL is an Equal Employment 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. We will reasonably accommodate all individuals with disabilities so that they can participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment. Please contact us to request accommodation. GRAIL maintains a drug-free workplace.
    $94k-141k yearly est. Auto-Apply 60d+ ago
  • Operations Engineer 2, MSAT # 4411

    Grail 4.2company rating

    Grail job in Durham, NC

    Our mission is to detect cancer early, when it can be cured. We 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. We are a healthcare company, pioneering new technologies to advance early cancer detection. We have built a multi-disciplinary organization of scientists, engineers, and physicians and we are using the power of next-generation sequencing (NGS), population-scale clinical studies, and state-of-the-art computer science and data science to overcome one of medicine's greatest challenges. GRAIL is headquartered in Menlo Park, California, with locations in Washington, D.C., North Carolina, and the United Kingdom. It is supported by leading global investors and pharmaceutical, technology, and healthcare companies. For more information, please visit grail.com. GRAIL is seeking an Operations Engineer 2 for the Manufacturing Sciences and Technology team. As an Operations Engineer 2, you will provide support for Manufacturing and Lab Operations activities. Responsibilities will include the installation, maintenance, and sustained performance of cutting-edge laboratory equipment along with documenting activities in accordance with regulatory compliance guidelines. Laboratory equipment supported will range widely, but will include next-generation sequencing platforms and automated liquid handling robots. Strong interpersonal, organizational, and troubleshooting skills are essential for success in this position. This is a full time, onsite position working in the Research Triangle Park, NC lab.This is a first shift position, Monday to Friday starting at 8:00AM.Work on holidays may be required.On-call work may be required.Working hours may be temporarily adjusted due to training, travel, and other events.Responsibilities: Lead and perform live troubleshooting, recovery, debugging, repairs, and maintain equipment and systems in good working order to support the area and operators' day to day following cGMP/GLP and Quality Management System (QMS) guidelines in a timely manner Make time sensitive technical decisions; collaborate and escalate when appropriate Ensure day-to-day reliability and maintainability of equipment, processes, mechanical, electrical, control, and safety/security systems following cGMP/GLP and Quality Management System (eQMS) guidelines Reduce and improve unplanned maintenance events wherever feasible, ensuring efficient and productive operation of equipment Execute and document equipment lifecycle related activities (installations, maintenance, calibration, repairs, etc) by supporting and maintaining equipment records in and out of our Asset Management System for traceability purposes and to assure compliance with CLIA/CAP, FDA 21 CFR part 820, and ISO 13485 requirements Maintain Asset Management System(s) to support internal Equipment Program processes and procedures Execute procedures, work instructions, guidelines, and testing documents such as installation / operational / performance qualification (IOPQ), site acceptance test (SAT), verifications, standard operating procedures (SOP) Serve as a primary point of contact for hosting vendor IQ, OQ, calibration, PM, and/or repairs with minimal supervision Ensure that all work performed by external contractors is completed and documented in accordance with the site Quality Management System (QMS) and safety guidelines Work closely with quality and regulatory to determine, include, implement and follow the required policies, requirements, and procedures for equipment lifecycle events Author and lead DAR implementations where needed; may lead equipment and equipment integration- related Change Controls for qualified assets Respond to environmental monitoring system alert notifications for areas of responsibility Required Qualifications: BS/BA or equivalent in Engineering, Physics, Chemistry or Life Sciences with 2+ years of experience working on laboratory equipment or in an equivalent program AS or applicable certification with 5+ years of experience working on laboratory equipment or equivalent program 1+ years Hands-on experience maintaining and supporting general molecular laboratory equipment (hardware and software systems) and following appropriate safety procedures 1+ years experience technically troubleshooting and maintaining liquid handling equipment and software components (e.g., Agilent, Hamilton, Labcyte, Illumina etc.) 1+ years experience working in a regulated laboratory environment 1+ years experience working with IT networking and systems infrastructure 1+ years experience working within a computerized maintenance/calibration management system Excellent communication skills to serve as a point of contact for internal customer support Excellent time management skills to support a fast paced working environment Ability to travel up to 10% of the time Physical Demands and Working Environment: Regularly required to stand, sit, walk, climb stairs/ladders, kneel, crouch, and wear safety gear Occasionally work with dry ice or materials stored at very low temperatures Must be able to stand or sit for long periods of time May be exposed to hazardous materials, blood specimens and equipment with moving parts, heating or freezing elements, and high speed centrifugation Working on confined spaces may be necessary Must regularly lift and / or move up to 10 pounds Must frequently lift and/or move up to 25 pounds Must occasionally lift and/or move up to 50 pounds The expected, full-time, annual base pay scale for this position is $82K - $100K for Durham, NC. Actual base pay will consider skills, experience, and location. Based on the role, colleagues may be eligible to participate in an annual bonus plan tied to company and individual performance, or an incentive plan. We also offer a long-term incentive plan to align company and colleague success over time. In addition, GRAIL offers a competitive benefit package, including flexible time-off, a 401(k) with a company % match, medical, dental, and vision insurance plans, and carefully selected mindfulness offerings, in accordance with our applicable plans and policies. GRAIL is an equal employment opportunity employer, and we are committed to building a workplace where every individual can thrive, contribute, and grow. It is GRAIL policy to provide equal employment opportunities without regard to race, color, religion, national origin, sex, gender, gender identity, sexual orientation, age, marital status, protected veteran status, disability status, medical condition, or any other class or characteristic protected by applicable federal, state, and local laws. This policy applies to all phases of employment, including, but not limited to: recruiting, hiring, training, promotion, and termination at all levels of employment. GRAIL maintains a drug-free workplace. Additionally, GRAIL will consider all qualified job-seekers with criminal histories in a manner consistent with applicable law and provide reasonable accommodations to qualified individuals with disabilities so that they can participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment. Please contact us at *************** if you require an accommodation to apply for an open position. For more information about equal employment opportunity protections, please view the 'Know Your Rights' poster. We welcome job-seekers from all backgrounds to join us!
    $82k-100k yearly Auto-Apply 32d ago
  • CLIA Laboratory Director (Board Certified Molecular Pathologist, MD) #4328

    Grail 4.2company rating

    Grail job in Durham, NC

    Our mission is to detect cancer early, when it can be cured. We 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. We are a healthcare company, pioneering new technologies to advance early cancer detection. We have built a multi-disciplinary organization of scientists, engineers, and physicians and we are using the power of next-generation sequencing (NGS), population-scale clinical studies, and state-of-the-art computer science and data science to overcome one of medicine's greatest challenges. GRAIL is headquartered in Menlo Park, California, with locations in Washington, D.C., North Carolina, and the United Kingdom. It is supported by leading global investors and pharmaceutical, technology, and healthcare companies. For more information, please visit grail.com. The CLIA Laboratory Director, Board Certified Pathologist, MD is responsible for providing oversight of the GRAIL CLIA Laboratory, including the employment of personnel who are competent to perform test procedures, record and report test results promptly, accurately and proficiently, and for ensuring compliance with the applicable regulations and accreditation requirements. The Lab Director may delegate certain responsibilities to other properly trained staff, but nonetheless has ultimate responsibility to ensure that all delegated duties are properly performed.Responsibilities: Perform routine data review, interpretation and report release for commercially offered molecular diagnostic assays Act as subject matter expert for the clinical laboratory, leading investigations and troubleshooting initiatives as necessary Participate in process monitoring, clinical and market surveillance activities Review and approve documentation relevant to laboratory operations Be responsible for oversight and implementation of the laboratory quality management system including review of non-comformance documentation and participation in corrective/preventive action and change control boards Provide lab oversight with a focus on patient care across the preanalytic, analytic, and postanalytic phases of testing as dictated by College of American Pathologists (CAP) and New York State Department of Health (NYSDOH) standards Ensure accurate and effective communication of laboratory data and appropriate patient result reporting to authorized recipients Serve as Clinical Consultant regarding the ordering of appropriate tests and clinical significance of laboratory data, as appropriate Regularly attend meetings to discuss the management and operation of the laboratory Interact with the R&D teams to provide insights for new test development Review and approves the technical performance validation and verification reports for new tests, instruments, and methods prior to being used for patient testing Participate in routine audits of the clinical laboratory as lab director and medical subject matter expert Preferred Qualifications: MD or DO with Board Certification in Molecular Genetic Pathology (MGP) by the American Board of Pathology (ABP/ABMGG), and an active North Carolina medical license (or eligibility to obtain). Fellowship training in Molecular Genetic Pathology strongly preferred. Must meet all applicable federal (42 CFR Subpart M Part 493.1443), CAP, and New York State (Title 10, NYCRR, Part 19) requirements for directors of high-complexity clinical testing. Minimum of 3 years' experience directing a molecular diagnostics laboratory or serving as a technical supervisor in a molecular diagnostics laboratory. Proven expertise in molecular diagnostics, including test interpretation, report review, and oversight of quality management systems. Strong leadership skills with experience ensuring compliance with CAP, CLIA, and NYSDOH standards. Eligible to obtain a New York State Certificate of Qualification in Oncology, Molecular and Cellular Tumor Markers. The expected, full-time, annual base pay scale for this position is $225,000.00 - 322,500.00 for NC. Actual base pay will consider skills, experience, and location. Based on the role, colleagues may be eligible to participate in an annual bonus plan tied to company and individual performance, or an incentive plan. We also offer a long-term incentive plan to align company and colleague success over time. In addition, GRAIL offers a progressive benefit package, including flexible time-off, a 401k with a company match, and alongside our medical, dental, vision plans, carefully selected mindfulness offerings. GRAIL is an Equal Employment 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. We will reasonably accommodate all individuals with disabilities so that they can participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment. Please contact us to request accommodation. GRAIL maintains a drug-free workplace.
    $40k-80k yearly est. Auto-Apply 60d+ ago
  • Equipment Engineering Technician II, 1st Shift #4245 (Sunday through Wednesday, 6:00am-4:30pm)

    Grail 4.2company rating

    Grail job in Durham, NC

    Our mission is to detect cancer early, when it can be cured. We 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. We are a healthcare company, pioneering new technologies to advance early cancer detection. We have built a multi-disciplinary organization of scientists, engineers, and physicians and we are using the power of next-generation sequencing (NGS), population-scale clinical studies, and state-of-the-art computer science and data science to overcome one of medicine's greatest challenges. GRAIL is headquartered in Menlo Park, California, with locations in Washington, D.C., North Carolina, and the United Kingdom. It is supported by leading global investors and pharmaceutical, technology, and healthcare companies. For more information, please visit grail.com. GRAIL is seeking an Equipment Technician II for the Engineering Operations team. The Equipment Technician II will support equipment lifecycle activities for GRAIL in-house Operations. Activities may fall within the selection, installation, operation, or decommissioning phases of the equipment lifecycle and may include preventative and corrective maintenance, project work, repairs, calibration, improvements, qualifications, etc. The successful candidate will be a self-starter who follows standards and guidelines. GRAIL's testing volumes are scaling fast and require a dynamic and detail-oriented technician to help deliver our revolutionary test to as many people as possible. This is a full time, onsite position working in the Research Triangle Park, NC lab between the hours of 6:00 AM to 4.30 PM.Position is 10 hour shifts, 4 days a week, available for Sunday through Wednesday.Working on holidays may be required.Working hours may be temporarily adjusted due to training, travel, and other events.Responsibilities: Execute and document equipment lifecycle related activities including but not limited to: installations, scheduled maintenance, calibrations, internal qualifications, and repairs. Perform asset inventories and inspections, remediate any found discrepancies between the Asset Management System and asset tags and stickers. Perform routine audits of equipment records in our Asset Management System to confirm traceability and compliance with CLIA/CAP, FDA 21 CFR Part 820, and ISO 13485 requirements. Support routine service provider visits, internal and cross-functional investigations, and software / firmware upgrades and assessments. Respond to the Engineering Operations support ticketing system in a timely manner, escalating where appropriate. Respond to environmental monitoring system alert notifications for cold storage units and laboratory temperature/humidity sensors in a timely manner, escalating where appropriate. May update controlled documentation including standard operating procedures, work instructions, guidelines, and qualification / verification protocols. Preferred Qualifications: 2+ years of related experience with an Associates degree or higher in a technical field, or equivalent military training 2+ years experience using acquired skills to perform a range of routine tasks in support of daily operations, under general supervision. 2+ years experience carrying out work independently, in accordance with existing policies, protocols and instructions, with some discretion required. 2+ years experience evaluating and selecting appropriate solutions from a set of established operating procedures Some experience working on semi-routine processes or processes that are under development Some experience identifying situations in which deviations from standard practice may be needed and appropriate General understanding of how daily support tasks contribute to the success of operational goals. 1+ years experience using Blue Mountain RAM or similar asset management software 1+ years experience with Laboratory Information Management Systems (LIMS) 1+ years experience with Manufacturing Management Systems (MES), scheduling software, or Customer Relationship Management (CRM) software 1+ years experience performing equipment calibrations Physical Demands & Working Environment Regularly required to stand, sit, walk, climb stairs/ladders, kneel, crouch, and wear safety gear. Occasionally work with dry ice or materials stored at very low temperatures. Must be able to stand or sit for long periods of time. May be exposed to hazardous materials, blood specimens and instruments with moving parts, heating or freezing elements, and high speed centrifugation. Must regularly lift and / or move up to 10 pounds. Must frequently lift and/or move up to 25 pounds. Must occasionally lift and/or move up to 50 pounds. Travel may be required, up to 10% of the time. The expected, base hourly rate for this position is $24.00/hour - $28.00/hour for Menlo Park, CA. Actual base rate will consider skills, experience, and location. Based on the role, colleagues may be eligible to participate in an annual bonus plan tied to company and individual performance, or an incentive plan. We also offer a long-term incentive plan to align company and colleague success over time. In addition, GRAIL offers a progressive benefit package, including flexible time-off, a 401k with a company match, and alongside our medical, dental, vision plans, carefully selected mindfulness offerings. GRAIL is an Equal Employment 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. We will reasonably accommodate all individuals with disabilities so that they can participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment. Please contact us to request accommodation. GRAIL maintains a drug-free workplace.
    $24-28 hourly Auto-Apply 60d+ ago
  • Clinical Laboratory Associate IV, Accessioning # 4391

    Grail 4.2company rating

    Grail job in Durham, NC

    Our mission is to detect cancer early, when it can be cured. We 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. We are a healthcare company, pioneering new technologies to advance early cancer detection. We have built a multi-disciplinary organization of scientists, engineers, and physicians and we are using the power of next-generation sequencing (NGS), population-scale clinical studies, and state-of-the-art computer science and data science to overcome one of medicine's greatest challenges. GRAIL is headquartered in Menlo Park, California, with locations in Washington, D.C., North Carolina, and the United Kingdom. It is supported by leading global investors and pharmaceutical, technology, and healthcare companies. For more information, please visit grail.com. The focus of the clinical laboratory associate will be on the receipt, triage, and accessioning of patient samples submitted to the CLIA laboratory for testing. Responsibilities: Responsible for unpacking samples from shipping containers and accessioning samples into LIMS including troubleshooting sample issue and LIMS errors. Be able to prioritize workload to meet production goals in throughput and quality. Responsible for equipment maintenance according to the laboratory's standard operating procedures. Responsible for maintaining sufficient inventory of materials, supplies, and equipment in the laboratory for performance of duties. Check, monitor, and record temperature and perform root cause analysis of deviations and implement a resolution or initiate a service request as necessary. Document all corrective actions taken when test systems deviate from the laboratory's established performance specifications. Assist in performing annual review of standard operating procedures. Manage organizing and maintaining laboratory, equipment, personnel, and training documents. Report all concerns of test quality and/or safety to the Supervisor or Safety Officer. Identify process improvement opportunities and report to laboratory management. Write and revise standard operating procedures, as needed. Perform other duties as assigned. Preferred Qualifications: Required AA or high school diploma with lab experience. Prefer at least 3 + years of related experiences in a high complexity laboratory. Demonstrate a high level of competency when following processing steps in protocol and in all other supporting functions. Strong communicator with ability to maintain open communication with internal employees, managers and customers as needed. Strong organizational skills and meticulous attention to detail. Able to integrate and apply feedback in a professional manner. Able to prioritize and drive to results with a high emphasis on quality. Ability to work as part of a team within a highly collaborative environment. Strong computer skills. Ability to proactively communicate consistently, clearly and honestly. Ability to prioritize tasks with a high emphasis on quality. Ability to participate in projects and complete assignments as expected. Ability to analyze and solve basic issues. High volume laboratory experience preferred. Flexibility of work schedule to meet the needs of GRAIL's Clinical Laboratory. Physical Demands and Working Environment Hours and days may vary depending on operational needs Working with dry ice may be necessary Standing or sitting for long periods of time may be necessary. May be exposed to hazardous materials, blood specimens and instruments with moving parts, heating or freezing elements, and high speed centrifugation (Generally laboratory and customer service employees only) Repetitive manual pipetting may be necessary Some lifting (up to 25 pounds) may be necessary The expected, full-time, annual base pay scale for this position is $27.88/hour - $32.69/hour. Actual base pay will consider skills, experience, and location. Based on the role, colleagues may be eligible to participate in an annual bonus plan tied to company and individual performance, or an incentive plan. We also offer a long-term incentive plan to align company and colleague success over time. In addition, GRAIL offers a competitive benefit package, including flexible time-off, a 401(k) with a company % match, medical, dental, and vision insurance plans, and carefully selected mindfulness offerings, in accordance with our applicable plans and policies. GRAIL is an equal employment opportunity employer, and we are committed to building a workplace where every individual can thrive, contribute, and grow. It is GRAIL policy to provide equal employment opportunities without regard to race, color, religion, national origin, sex, gender, gender identity, sexual orientation, age, marital status, protected veteran status, disability status, medical condition, or any other class or characteristic protected by applicable federal, state, and local laws. This policy applies to all phases of employment, including, but not limited to: recruiting, hiring, training, promotion, and termination at all levels of employment. GRAIL maintains a drug-free workplace. Additionally, GRAIL will consider all qualified job-seekers with criminal histories in a manner consistent with applicable law and provide reasonable accommodations to qualified individuals with disabilities so that they can participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment. Please contact us at *************** if you require an accommodation to apply for an open position. For more information about equal employment opportunity protections, please view the 'Know Your Rights' poster. We welcome job-seekers from all backgrounds to join us!
    $27.9-32.7 hourly Auto-Apply 3d ago
  • Quality Engineer 2, Device Quality Operations # 4376

    Grail 4.2company rating

    Grail job in Durham, NC

    Our mission is to detect cancer early, when it can be cured. We 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. We are a healthcare company, pioneering new technologies to advance early cancer detection. We have built a multi-disciplinary organization of scientists, engineers, and physicians and we are using the power of next-generation sequencing (NGS), population-scale clinical studies, and state-of-the-art computer science and data science to overcome one of medicine's greatest challenges. GRAIL is headquartered in Menlo Park, California, with locations in Washington, D.C., North Carolina, and the United Kingdom. It is supported by leading global investors and pharmaceutical, technology, and healthcare companies. For more information, please visit grail.com. This position is a key individual contributor in the Quality Operations organization, responsible for executing, maintaining, supporting, and improving GRAIL's quality management system (QMS). This role's focus is on the in vitro diagnostic medical device processes, supporting the clinical laboratory processes as needed with consideration for the single GRAIL QMS. This position interacts with departments throughout the organization including but not limited to all-Quality, Clinical Laboratory Operations, Technical Operations, Regulatory Affairs, Compliance, ProgramManagement, ClinicalAffairs, Supply Chain, Manufacturing, and Research &Development. The person in this role consistently applies critical thinking skills and good judgment to solve complex problems, effectively communicating status and recommendations to management. This position requires regular on-site presence (5 days a week) Responsibilities: Support medical device Quality Engineering operations through expert interpretation, establishment, and execution of quality engineering concepts and principles in accordance with GRAIL's quality management system and regulatory requirements including ISO 13485, ISO 14971, 21 CFR 820, IVDR, and related regulations and standards. Use proactive, creative problem-solving to contribute to development of concepts and principles to achieve goals and objectives. Demonstrate technical proficiency, creativity, teamwork, collaboration with others, and regular independent thought. Solve extremely complex problems in which analysis of situations or data requires an in-depth evaluation and assessment of intangible variables. Exercise excellent judgment within broadly defined practices and policies in selecting methods, techniques, and evaluation criteria for obtaining results. Act independently to determine methods and procedures to successfully complete assignments. Structure day-to-day work autonomously, effectively communicating status and issues with management. Identify and evaluate deficiencies and improvement opportunities, working cross-functionally to resolve and improve on existing processes. Support qualifications & validation activities (IQ/OQ/PQ/TMV) Support DHR review process Support NCR, DAR & CAPA process Support change management workflows, and acceptance activities including incoming and finished product release. Support Quality Management Review (QMR), Quality Indices metrics generation and review, audits, and on-market Design History File and Risk Management File updates. Support audits and inspections as needed Support other project teams (including clinical laboratory) as determined by management. Required Qualifications: Bachelor's degree in science, engineering, or other technical area. Minimum of 5 years of experience working within a medical device, pharmaceutical, or biotech quality management system. Experience working with in vitro diagnostic medical device regulations and standards including ISO 13485:2016, 21 CFR 820, IVDR, and other applicable industry requirements. Strong written and verbal communication skills. Ability to comprehend and interpret technical information. The expected, full-time, annual base pay scale for this position is $82K - $96K for NC. Actual base pay will consider skills, experience, and location. Based on the role, colleagues may be eligible to participate in an annual bonus plan tied to company and individual performance, or an incentive plan. We also offer a long-term incentive plan to align company and colleague success over time. In addition, GRAIL offers a competitive benefit package, including flexible time-off, a 401(k) with a company % match, medical, dental, and vision insurance plans, and carefully selected mindfulness offerings, in accordance with our applicable plans and policies. GRAIL is an equal employment opportunity employer, and we are committed to building a workplace where every individual can thrive, contribute, and grow. It is GRAIL policy to provide equal employment opportunities without regard to race, color, religion, national origin, sex, gender, gender identity, sexual orientation, age, marital status, protected veteran status, disability status, medical condition, or any other class or characteristic protected by applicable federal, state, and local laws. This policy applies to all phases of employment, including, but not limited to: recruiting, hiring, training, promotion, and termination at all levels of employment. GRAIL maintains a drug-free workplace. Additionally, GRAIL will consider all qualified job-seekers with criminal histories in a manner consistent with applicable law and provide reasonable accommodations to qualified individuals with disabilities so that they can participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment. Please contact us at *************** if you require an accommodation to apply for an open position. For more information about equal employment opportunity protections, please view the 'Know Your Rights' poster. We welcome job-seekers from all backgrounds to join us!
    $82k-96k yearly Auto-Apply 60d+ ago
  • Senior Scientist Technical Operations # 4375

    Grail 4.2company rating

    Grail job in Durham, NC

    Our mission is to detect cancer early, when it can be cured. We 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. We are a healthcare company, pioneering new technologies to advance early cancer detection. We have built a multi-disciplinary organization of scientists, engineers, and physicians and we are using the power of next-generation sequencing (NGS), population-scale clinical studies, and state-of-the-art computer science and data science to overcome one of medicine's greatest challenges. GRAIL is headquartered in Menlo Park, California, with locations in Washington, D.C., North Carolina, and the United Kingdom. It is supported by leading global investors and pharmaceutical, technology, and healthcare companies. For more information, please visit grail.com. The Senior Scientist, Technical Operations is responsible for supporting sustaining operations and introducing new assays and diagnostic products into GRAIL's high‑throughput, regulated laboratory environment. This individual contributor partners closely with MSAT, Assay Development, Engineering Operations, and the Clinical Lab to lead process integration, improvement, monitoring, and troubleshooting. The ideal candidate brings deep expertise across the end‑to‑end laboratory workflow-from pre‑analytical through post‑analytical-strong process optimization experience, and a thorough understanding of clinical laboratory regulatory frameworks. This position is onsite full-time, with 5 days per week at our facility. Additionally, the role requires participation in a rotating schedule for weekend and holiday coverage (when applicable), as part of ensuring continuous support for critical laboratory operations. Responsibilities: * Lead or assist in process troubleshooting activities, including root-cause analysis and impact assessments, resolving technical challenges. * Monitor process performance, analyze data and metrics, and contribute to process monitoring and improvement strategies to sustain high-quality, efficient operations. * Support the transfer and implementation of new assays and diagnostic products from development into production, ensuring robust performance across all workflow phases. * Develop, optimize, and document validation protocols and procedures in compliance with CLIA, CAP, NYS, ISO 13485, FDA, and other applicable standards. * Provide scientific and technical support to MSAT, Engineering Operations, and Clinical Lab teams. * Evaluate, qualify, and implement alternative reagents and vendors to maintain continuity and strengthen lab operations. * Identify process gaps and contribute to or lead process improvement initiatives to enhance efficiency, reliability, and quality. * Prepare comprehensive technical documentation, scientific reports, and regulatory submission materials as required. * Maintain high standards of scientific rigor, quality, and regulatory compliance in all process integration activities. * Lead complex investigations and root-cause analyses; implement effective CAPAs and preventive measures with clear verification of effectiveness * Support lab readiness: training, tech transfer materials, troubleshooting guides, and operational playbooks for Clinical Lab teams * Analyze complex datasets and present insights to technical and non-technical stakeholders to guide decisions * Contribute to inspection/audit readiness and support interactions with CAP/CLIA, state agencies (e.g., NYS), and other regulatory bodies as needed Required Qualifications: * PhD in Life Sciences, Molecular Biology, Biochemistry, Bioengineering, or a related field. * Proven experience in technology transfer of assays and launching new products in a regulated diagnostic laboratory. * Direct, hands-on experience with end-to-end clinical workflows (pre-analytical, analytical, and post-analytical). * Strong knowledge of high-throughput laboratory automation and advanced instrumentation. * Deep understanding of clinical laboratory regulatory standards, including CLIA, CAP, NYS, ISO 13485, and FDA. * Experience with or understanding of reagent manufacturing and alternative vendor qualification processes. * Experience participating in audits (internal, regulatory, or client-driven). * Excellent skills in technical documentation and scientific writing. * Demonstrated ability to collaborate effectively across MSAT, Engineering Operations, and Clinical Lab teams. * Six Sigma certification or significant experience with Lean, Kaizen, or other process improvement methodologies. * Hands-on experience with data analytics tools and platforms (e.g., JMP, Minitab, R, Python, Tableau) for process monitoring, analysis, and reporting. * Experience with laboratory information management systems (LIMS) or MES. * Advanced data analysis skills applied to laboratory operations and quality improvement. * Experience supporting laboratory scale-up, automation, or operational excellence projects. Expected full time annual base pay scale for this position is $119K - $142K. Actual base pay will consider skills, experience and location. Based on the role, colleagues may be eligible to participate in an annual bonus plan tied to company and individual performance, or an incentive plan. We also offer a long-term incentive plan to align company and colleague success over time. In addition, GRAIL offers a competitive benefit package, including flexible time-off, a 401(k) with a company % match, medical, dental, and vision insurance plans, and carefully selected mindfulness offerings, in accordance with our applicable plans and policies. Learn more about our benefits here: px.sequoia.com/grail GRAIL is an equal employment opportunity employer, and we are committed to building a workplace where every individual can thrive, contribute, and grow. It is GRAIL policy to provide equal employment opportunities without regard to race, color, religion, national origin, sex, gender, gender identity, sexual orientation, age, marital status, protected veteran status, disability status, medical condition, or any other class or characteristic protected by applicable federal, state, and local laws. This policy applies to all phases of employment, including, but not limited to: recruiting, hiring, training, promotion, and termination at all levels of employment. GRAIL maintains a drug-free workplace. Additionally, GRAIL will consider all qualified job-seekers with criminal histories in a manner consistent with applicable law and provide reasonable accommodations to qualified individuals with disabilities so that they can participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment. Please contact us at [email protected] if you require an accommodation to apply for an open position. For more information about equal employment opportunity protections, please view the 'Know Your Rights' poster. We welcome job-seekers from all backgrounds to join us!
    $119k-142k yearly 26d ago
  • Staff Data Engineer (Menlo Park, CA ) #4433

    Grail 4.2company rating

    Grail job in Durham, NC

    Our mission is to detect cancer early, when it can be cured. We 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. We are a healthcare company, pioneering new technologies to advance early cancer detection. We have built a multi-disciplinary organization of scientists, engineers, and physicians and we are using the power of next-generation sequencing (NGS), population-scale clinical studies, and state-of-the-art computer science and data science to overcome one of medicine's greatest challenges. GRAIL is headquartered in Menlo Park, California, with locations in Washington, D.C., North Carolina, and the United Kingdom. It is supported by leading global investors and pharmaceutical, technology, and healthcare companies. For more information, please visit grail.com . We design, optimize, and manage GRAIL's end-to-end data lifecycle, from sample ingestion through analysis, ensuring every step meets rigorous regulatory and clinical standards. We are seeking a Staff Software Engineer to help deliver the high-quality datasets that power research, analytics, and scientific insights. In this role, you will collaborate with cross-functional teams to deliver scalable data solutions aligned with FDA and global health authority requirements. Our ideal candidate brings experience in the life sciences and a strong background in data processing, infrastructure and operational excellence. This role is based in Menlo Park, California, and will move to Sunnyvale, California in Fall 2026. It offers a flexible work arrangement, with the ability to work from GRAIL's office or from home. Our current flexible work arrangement policy requires that a minimum of 60%, or 24 hours, of your total work week be on-site. Your specific schedule, determined in collaboration with your manager, will align with team and business needs and could exceed the 40% requirement for the site. At our Menlo Park campus, Tuesdays and Thursdays are the key days where we encourage on-site presence to engage in events and on-site activities. **Responsibilities** + Contribute to a highly collaborative team focused on delivering value to cross-functional partners by implementing processes and tools that prepare analysis-ready datasets. + Integrate inputs from diverse data sources across the organization into well-structured, harmonized datasets. + Build and maintain access controls and data-delivery mechanisms that uphold stringent blinding and privacy standards. + Partner with Research, Clinical Lab Operations, and Software Engineering teams to define and implement data transformations that support downstream analysis. + Ensure all delivered data adheres to software quality expectations, clinical compliance requirements, sequestration protocols, and privacy regulations. + Implement automated testing and release processes to improve the reliability, quality, and velocity of software and data deliveries. + Mentor engineers and scientists, promoting best practices in software development, data engineering, and operational rigor. **Preferred Qualifications** + BS/MS/PhD in a quantitative field (e.g., Computer Science, Engineering, Mathematics, Statistics, Bioinformatics) or equivalent and 6+ years of experience in data engineering, ideally within a regulated biotechnology, pharmaceutical, medical device, or healthcare environment. + Deep knowledge of ETL/ELT workflows, data pipeline development, and database management, with demonstrated success delivering data solutions for clinical or regulatory use cases. + Expertise in SQL and proficiency in Go and Python. Experience with R would be nice to have. + Experience with cloud-based data platforms (AWS, Azure, or Google Cloud) and preferably an understanding of compliance frameworks such as HIPAA and GDPR. + Strong analytical and problem-solving skills, with a track record of maintaining data quality and integrity across complex datasets. + Proven experience working on cross-functional teams and translating user requirements into scalable, high-quality data solutions. + Hands-on experience with relational databases, data modeling, data pipeline tools, and workflow engines (e.g., SQL, dbt, Apache Airflow, AWS Glue, Spark). + Familiarity with DevOps practices, including CI/CD pipelines, containerized deployment (e.g., Kubernetes), and infrastructure-as-code (e.g., Terraform). + Ability to navigate ambiguity, refine evolving requirements, and work with product and stakeholder teams to drive clear engineering objectives and designs. + Excellent written and verbal communication skills, with the ability to tailor technical content to diverse audiences. Expected full time annual base pay scale for the bay area is $163K-$216K. Actual base pay will consider skills, experience and location. Based on the role, colleagues may be eligible to participate in an annual bonus plan tied to company and individual performance, or an incentive plan. We also offer a long-term incentive plan to align company and colleague success over time. In addition, GRAIL offers a competitive benefit package, including flexible time-off, a 401(k) with a company % match, medical, dental, and vision insurance plans, and carefully selected mindfulness offerings, in accordance with our applicable plans and policies. GRAIL is an equal employment opportunity employer, and we are committed to building a workplace where every individual can thrive, contribute, and grow. It is GRAIL policy to provide equal employment opportunities without regard to race, color, religion, national origin, sex, gender, gender identity, sexual orientation, age, marital status, protected veteran status, disability status, medical condition, or any other class or characteristic protected by applicable federal, state, and local laws. This policy applies to all phases of employment, including, but not limited to: recruiting, hiring, training, promotion, and termination at all levels of employment. GRAIL maintains a drug-free workplace. Additionally, GRAIL will consider all qualified job-seekers with criminal histories in a manner consistent with applicable law and provide reasonable accommodations to qualified individuals with disabilities so that they can participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment. Please contact us at *************** if you require an accommodation to apply for an open position. For more information about equal employment opportunity protections, please view the 'Know Your Rights (**************************** ' poster. We welcome job-seekers from all backgrounds to join us!
    $163k-216k yearly 37d ago
  • Supervisor Accessioning, CLIA Laboratory # 4392 (Tuesday - Saturday 9:30am - 6pm)

    Grail 4.2company rating

    Grail job in Durham, NC

    Our mission is to detect cancer early, when it can be cured. We 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. We are a healthcare company, pioneering new technologies to advance early cancer detection. We have built a multi-disciplinary organization of scientists, engineers, and physicians and we are using the power of next-generation sequencing (NGS), population-scale clinical studies, and state-of-the-art computer science and data science to overcome one of medicine's greatest challenges. GRAIL is headquartered in Menlo Park, California, with locations in Washington, D.C., North Carolina, and the United Kingdom. It is supported by leading global investors and pharmaceutical, technology, and healthcare companies. For more information, please visit grail.com. The Supervisor, Accessioning is responsible for the general supervision of Accessioning Clinical Laboratory personnel and the daily operations of the Pre-Analytical Laboratory. The nature of the work requires excellent attention to detail, effective written and verbal communication skills, the ability to multitask and be flexible with tasks and schedules, and the ability to work independently and in a team environment! Responsibilities: * Provide day-to-day supervision of laboratory personnel and participate in daily Accessioning work as needed. * Be responsible for the daily pre-analytical operations of the laboratory including but not limited to scheduling, independently troubleshooting and resolving technical and non-technical high complexity problems. * Independently identify and troubleshoot high complexity problems that would adversely affect test performance. * Perform administrative duties including but not limited to writing employee performance evaluations and reviewing SOPs, protocols, QC forms, and equipment maintenance forms. * Coach and mentor Laboratory Assistants including but not limited to providing guidance and constructive feedback and assisting with the development of troubleshooting and judgment. * Collaborate with the product development and software engineering teams to enhance the LIMS capabilities for accuracy and scale. * Streamline existing workflows and laboratory space to enable high-throughput processes and high accessioning volume. * Perform, review and document laboratory quality control procedures, as needed. Operate, maintain, and troubleshoot laboratory equipment, as needed. * Coordinate the training of new laboratory personnel and training of new procedures with existing personnel. Participate in quality assurance activities. * Effectively communicate technical information to technical and non-technical audiences. * Maintain stringent standards for quality, identifying any issues which might adversely impact the quality of test results and/or employee safety, and presenting these to the appropriate management representatives as vital for resolution. * Report all concerns of test quality and/or safety to the Supervisor or Safety Officer. Required Qualifications: * Bachelor of Science, or an equivalent combination of training and experience. * Working knowledge of local, state, and federal laboratory regulations. * At least three years of CAP/CLIA certified Laboratory Supervisory experience or equivalent. * Exceptional understanding of CAP, CLIA and NYSDOH regulations. * Strong communicator with ability to maintain open communication with internal employees, managers and customers as needed. * Able to integrate and apply feedback in a professional manner. * Able to prioritize and drive to results with a high emphasis on quality. * Ability to work as part of a team Physical Demands and Working Environment * Hours and days may vary depending on operational needs. * Standing or sitting for long periods of time may be necessary. * May be exposed to hazardous materials, blood specimens and instruments with moving parts, heating or freezing elements, and high speed centrifugation. * Work on nights, weekends, and holidays may be required. The expected, full-time, annual base pay scale for this position is $78K - $97K in Durham, NC. Actual base pay will consider skills, experience, and location. Based on the role, colleagues may be eligible to participate in an annual bonus plan tied to company and individual performance, or an incentive plan. We also offer a long-term incentive plan to align company and colleague success over time. In addition, GRAIL offers a competitive benefit package, including flexible time-off, a 401(k) with a company % match, medical, dental, and vision insurance plans, and carefully selected mindfulness offerings, in accordance with our applicable plans and policies. Learn more about our benefits here: px.sequoia.com/grail GRAIL is an equal employment opportunity employer, and we are committed to building a workplace where every individual can thrive, contribute, and grow. It is GRAIL policy to provide equal employment opportunities without regard to race, color, religion, national origin, sex, gender, gender identity, sexual orientation, age, marital status, protected veteran status, disability status, medical condition, or any other class or characteristic protected by applicable federal, state, and local laws. This policy applies to all phases of employment, including, but not limited to: recruiting, hiring, training, promotion, and termination at all levels of employment. GRAIL maintains a drug-free workplace. Additionally, GRAIL will consider all qualified job-seekers with criminal histories in a manner consistent with applicable law and provide reasonable accommodations to qualified individuals with disabilities so that they can participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment. Please contact us at [email protected] if you require an accommodation to apply for an open position. For more information about equal employment opportunity protections, please view the 'Know Your Rights' poster. We welcome job-seekers from all backgrounds to join us!
    $78k-97k yearly 55d ago

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