Document Control Training Manager

ThermalWorks has an exciting opportunity for someone passionate about sustainability and eager to be part of an innovative company that’s on a journey to transform the world’s infrastructure. We are seeking a Safety Specialist to join the ThermalWorks team, working directly with the Environmental Manager, Field Service Supervisors, Lead Technicians, General Contractor, Safety Representatives, and the Customer Facility Operations teams , and focusing on administering the permit, training, inspection, and recordkeeping systems that the program requires. Audits compliance in the field and serves as ThermalWorks' point of contact for host site safety representatives, general contractors, and regulatory inspectors. Key Responsibilities Include but are not limited to: Program administration Maintain the Field Service Safety Program, Operations Procedure and SSSP Template as controlled documents, including the annual review and revision control. Verify regulatory citations and penalty figures at each review so that no employee-facing document carries a stale reference. Track EPA and OSHA developments affecting field service scope, including AIM Act refrigerant management and NFPA 70E revisions, and brief leadership before an effective date arrives. Maintain equipment-specific Energy Control Procedures and the ThermalWorks safety forms package. Permit and pre-task review Review energized electrical work permits for completeness before work proceeds, including de-energizing justification, arc flash and shock risk assessment, PPE determination and job briefing sign-off. Review confined space entry permits for the spaces routine to ThermalWorks scope, including atmospheric testing, continuous monitoring, attendant assignment and rescue provisions. Confirm that two-person requirements for energized testing are staffed before work is scheduled, and that no task requiring an attendant is assigned to a lone worker. Review Pre-Task Plans for energized, confined space, elevate

About the Team DoorDash Labs is an independent team within DoorDash. We explore robotics and automation to transform last-mile logistics in the long term. If you have a passion for applying robotics solutions in a service used by millions of people, then we want to talk to you! About the Role You will be a fundamental and experienced member of the Service Operations team at DoorDash Labs. You will complete more advanced diagnostic and repair work to maximize uptime, supporting our overall fleet utilization goals. You will report to the Associate Operations Manager, Service, in our DoorDash Labs organization. This is an on-site role with expectations of 100% in-office in Fremont, CA, San Jose, CA, or Sunnyvale, CA. You’re excited about this opportunity because you will… Execute any Senior Service Technician task and: Diagnose complex, intermittent, or unusual faults in robotic systems, modular components, and support vehicles, often requiring advanced troubleshooting techniques and interpretation of complex data Perform advanced repairs, including component-level troubleshooting and fixes on intricate electrical systems, control units, and associated hardware, with minimal supervision Interpret complex technical manuals, schematics, and diagnostic flowcharts to guide troubleshooting efforts Meticulously document complex diagnostic processes, root cause hypotheses, non-standard troubleshooting steps, repair details, and component failure information in the service management system, contributing potential updates to the knowledge base Provide technical guidance, mentorship, and on-the-job assistance to Level 2 Technicians for challenging tasks Work independently to manage and prioritize assigned workload effectively Calibrates, configures, and maintains specialized diagnostic tools and test equipment We operate 7 days a week, 16 hrs a day to support Robot Operations. During training, you will be on a temporary schedule until your on-the-job training is completed

Kincellis Advanced Therapies is a U.S.-based contract development and manufacturing organization supporting advanced-therapy developers from early-stage CMC, process and analytical development through clinical supply, pivotal-stage programs and commercial supply. With facilities in Gainesville, Florida; Research Triangle Park, North Carolina; and The Woodlands, Texas, Kincellis combines broad technical expertise with flexible, scalable GMP infrastructure across autologous and allogeneic therapies, including but not limited to CAR-T, Tregs, CAR-NK, MSCs, dendritic cell vaccines, exosomes, iPSCs & synthetic mRNA. For more information, visit our website at www.kincellis.com. The Senior Quality Assurance Associate supports the day-to-day early phase cell and gene therapy clinical GMP manufacturing operations via execution of all operational elements of the Quality Management System (QMS), including but not limited to the EDMS (electronic document management system) and training management system in support of gene and cell therapy manufacturing production. They will collaborate cross-functionally with Manufacturing, Supply Chain, Facilities, and the Laboratories to ensure cGMP compliance and establish a quality culture. This is a unique opportunity to help build and grow the Quality Assurance organization in a dynamic new environment. Experience with administrative access using Veeva as a document control and training management system preferred. Essential Duties and Responsibilities Reasonable accommodation may be made to enable individuals with disabilities to perform the essential functions of this position. This list contains the major duties and requirements of the job and is not all-inclusive. Incumbent(s) may be expected to perform role-related duties other than those contained in this document. Essential Duties and Responsibilities Assist in executing QA responsibilities to support material and product release. Work with Quality team mem

What you’ll do Own and evolve the Quality Management System (QMS) to support a regulated medical device development program, including design controls and DHF maintenance. Establish and enforce requirements traceability: user needs → design requirements → verification/validation artifacts and change control. Define and run the program-level V&V strategy (verification, validation, and test coverage), including test plans, protocols, reports, and acceptance criteria. Drive risk management activities (e.g., DFMEA / PFMEA, hazard analyses) and ensure mitigations are reflected in requirements and verification. Lead document control: reviews, approvals, training, retention, and audit readiness. Partner with engineering to make quality “native” to the dev workflow (automated testing, release gates, software configuration management). Prepare the program for audits and inspections, including hands-on audit leadership. What we’re looking for Senior experience leading quality for complex hardware + software products in a regulated environment. Deep familiarity with design controls, DHF, document control, risk management, and verification planning. Strong systems thinking and the ability to translate ambiguous product intent into testable requirements. Comfortable collaborating directly with multidisciplinary engineering (recon/ML, embedded, mechanical, EE, cloud). Useful experience Regulated product quality leadership (ISO 13485 / 21 CFR 820 or equivalent), including audit readiness and FDA-facing work. eQMS + document control fluency (e.g., Greenlight Guru) that integrates cleanly with modern engineering workflows.

What you’ll do Own day-to-day operations for the scanner program and scanner builds in the spa: purchasing/procurement, vendor management, receiving, inventory, and logistics. Stand up lightweight production operations as we move from prototypes to repeatable builds: build planning, kitting, work instructions, and readiness checklists. Partner with Quality to ensure the operational system supports compliance: traceability, document control, training records, NCR/CAPA workflows, and audit readiness. Drive cross-functional execution for the physical spa build-out and scanner integration: schedules, dependencies, risk register, and weekly coordination with vendors and internal teams. Own the “integration glue” across facilities + device ops: commissioning plans, acceptance criteria, and operational handoff (runbooks, maintenance, spares, escalation paths). Build and track operational metrics: cost, budget, lead times, vendor performance, build throughput, and reliability of critical subsystems. Audit of import/export documentation, management of contract renewals, regulatory compliance. What we’re looking for Proven operations leadership in hardware/medical/robotics (or similarly complex electromechanical products), including procurement and vendor management. Strong program management instincts: can run schedules, unblock cross-functional dependencies, and keep priorities clear under ambiguity. Comfort operating in quality/regulatory environments and building processes that are rigorous without slowing a small team. High ownership and bias to action: can jump between spreadsheets, docks, and the lab/site to keep the program moving. Useful experience Experience running prototype-to-production transitions (NPI, EVT/DVT/PVT-style builds, CM/EMS collaboration). Facilities / construction operations experience (GC coordination, MEP commissioning, site readiness). Familiarity with inventory systems and procurement tooling (even “simple but disciplined”).

About Tr1X Tr1X is a clinical-stage biotechnology company developing engineered Tr1 cell therapies to restore immune balance in autoimmune and inflammatory diseases. Leveraging the unique biology of Tr1 cells, the company is advancing a pipeline of off-the-shelf allogeneic and in vivo CAR-Tr1 therapies designed to deliver targeted immunoregulation and address diseases driven by immune dysfunction, including transplant-related complications. Founded by pioneers in the discovery of Tr1 cells, Tr1X, Inc. is focused on developing durable, potentially curative therapies for conditions with high unmet need. For more information, visit www.tr1x.bio . Position Summary The Senior Director, Quality (SD) reports to the Chief Technical Officer and is responsible for all aspects of the quality organization including support and oversight for all internal and external GxP operations inclusive of clinical quality assurance (CQA). As the leader of the quality function, the SD establishes and maintains a culture of quality across the organization and is responsible for overseeing development, implementation, and continuous improvement of all quality systems to ensure that all products, processes, and operations comply with applicable regulatory requirements. The SD is ultimately responsible and accountable for critical decisions that directly impact product integrity, patient safety, regulatory compliance, and business continuing. The SD works with both internal and external stakeholders to manage timelines, meet internal deliverables and develop a best-in-class quality organization. This position develops, leads, and coaches the teams responsible for quality systems, quality control, document control, quality assurance, clinical quality, and compliance. The SD responsibilities include implementation and continuous improvement of policies, procedures and standards necessary to ensure compliance with applicable GxPs. Additional responsibilities include team building, ca