QA/RA Document Control Specialist
2 weeks ago
The Document Control Specialist manages and maintains quality-related documentation, including SOPs and work instructions. This role ensures compliance with regulatory standards, oversees version control, and facilitates communication and training on document changes. The Specialist supports internal and external audits, utilizes Electronic Document Management Systems, and collaborates across departments to ensure the organization's adherence to quality management practices. Responsibilities: •Manage the Document Change Order (DCO) Process for the release, approval, distribution, maintenance, retrieval, and storage of quality system documents and records per the company's Standard Operating Procedures. •Support the Change Control Board (CCB) to process DCOs, implement changes, complete product disposition, and complete all DCO activities in a timely manner. •Maintain and support compliance activities associated with the Quality Management System (QMS) to comply with international and domestic regulations. •Manage the employee training program and maintain the training matrix by working with the hiring managers to ensure current training records, job description, and employee records are incompliance with company's Standard Operating Procedures. •Maintain control of electronic and hard copy of documents for SOPs, product specifications and drawings, inspection and manufacturing procedures, clinical documentation and protocols, process validation, design control, marketing and educational material and test reports. •Maintain and update Master Document List and Document Change Control Logs to ensure consistency and record keeping. •Support and Maintain Design History Files, Regulatory Technical files, Device Master Records, and other Design Dossier documents. •Assist with internal audits in compliance with the company's internal audit procedure •Maintain the quality systems databases to provide quality metrics data on routine basis or as required. •Prepare quality system trending information and prepare data summaries for management review meetings and other similar meetings as needed •Assists the Management Representative during external audits (FDA), Notified Body, California State Department of Public Health) •Support the Head of QA/RA during product development projects to ensure compliance and regulatory requirements are met throughout the development process. •Support the Head of QA/RA during regulatory submissions, responses, and communication with regulatory agencies such as the FDA and Notified Body. Qualifications: •High school diploma or equivalent. •2+ years of experience in biotech or medical device. •Knowledge in document control change process, quality assurance, and ISO 13485 Quality Management System. •Knowledge of medical device regulations and good manufacturing practices. •Attention to detail and a focus on continuous improvement.
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Document Control Specialist
4 weeks ago
Carlsbad, United States Precision NDT LLC Full timeJob DescriptionJob DescriptionA document control specialist is responsible for managing and storing a company's documents. They may also be responsible for:Scanning, imaging, and organizing documentsArchiving inactive documentsReviewing and organizing documentsProcessing requests for informationOrganizing and processing formsEnsuring document storage...
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Supervisory Air Traffic Control Specialist
4 weeks ago
Carlsbad, United States Federal Aviation Administration Full timeSummary Serves as an Operations Supervisor in an ATC-6 terminal facility responsible for planning and directing operations within delegated areas of responsibility. Serves as a member of the management team to improve organizational performance and to meet strategic goals. Duties Serves as an Operations Supervisor in an ATC-6 terminal facility...
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Controller
3 weeks ago
Carlsbad, United States Surf Search Full timeJob Title: Controller Location: San Diego, CA About the Company: Join a dynamic and rapidly expanding private medical device company poised for next year's public offering. Located in North San Diego, our client is at the forefront of medical technology, dedicated to developing advanced solutions that improve patient care. As they transition into a publicly...
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Production Control Planner
1 week ago
Carlsbad, United States Viasat, Inc. Full timeAbout us: One team. Global challenges. Infinite opportunities. At Viasat, we’re on a mission to deliver connections with the capacity to change the world. For more than 35 years, Viasat has helped shape how consumers, businesses, governments and militaries around the globe communicate. We’re looking for people who think big, act fearlessly, and create an...
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Senior Inventory Control Clerk
4 days ago
Carlsbad, United States GenMark Diagnostics Full time**Senior Inventory Control Clerk (2nd Shift)** **Department:** 3010 Supply Chain Team-Carlsbad **Location:** Carlsbad, CA **Internal Posting only:** or ***Beginning November 15, 2021, GenMark Diagnostics requires all new hires to be fully vaccinated against COVID-19 as of their start date.*** **WHAT YOU'LL DO AT GENMARK!** The Sr. Inventory Control Clerk...
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Senior Engineer
7 days ago
Carlsbad, United States Vuori, Inc. Full timeJob Description As a Sr. QA Engineer you will be part of a growing Digital Engineering team focusing on commerce platform & digital facing functions. You will be responsible for developing test cases, testing, and validating bugs and features that have been delivered. The ideal candidate will have 5+ years of experience, self-driven, excellent understanding...
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Corporate Controller
6 days ago
Carlsbad, United States Surf Search Full timeJob Title: Financial Controller Location: San Diego, CA About the Company: Join a dynamic and rapidly expanding private medical device company poised for next year's public offering. Located in North San Diego, our client is at the forefront of cardiovascular medical technology with plans to go public in 2025 As they transition into a publicly traded...
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Sr Work Control Planner
4 weeks ago
Carlsbad, United States Southern Tech Full timeJob DescriptionJob DescriptionWe are looking to hire a Sr Work Control Planner to join our team! You will be responsible for developing, planning, and reviewing work control documents (WCDs) to support work at the WIPP Site.Responsibilities:Develop and/or review of large and complex work packages, including written step-by-step work instructions,...
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Corporate Controller
7 days ago
Carlsbad, United States Surf Search Full timeJob Title: Financial Controller Location: San Diego, CA About the Company: Join a dynamic and rapidly expanding private medical device company poised for next year's public offering. Located in North San Diego, our client is at the forefront of cardiovascular medical technology with plans to go public in 2025 As they transition into a publicly traded...
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Maintenance Specialist I
1 month ago
Carlsbad, United States Glanbia Nutritionals Full timeBuilding Maintenance Specialist At Glanbia Nutritionals Inc., our portfolio centers on dairy and non-dairy nutritional ingredients. We co-innovate and deliver ingredient solutions and precision premixes for use in the mainstream food and beverage, infant and clinical, and functional nutrition markets. We are the number one provider of whey-based nutritional...
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Customer Technical Support Specialist l
5 days ago
Carlsbad, United States GenMark Diagnostics Full time**Customer Technical Support Specialist l** **Department:** 3025 Customer Technical Support **Location:** Carlsbad, CA **Internal Posting only:** or **HEROES WORK HERE!** We deliver innovative, diagnostic solutions that improve the lives of patients and their families and are proud to be one of the heroic diagnostic companies that is in this fight against...
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IT Support Specialist
4 weeks ago
Carlsbad, United States Talentry, LLC Full timeJob DescriptionJob DescriptionIT Service Desk Support SpecialistCarlsbad, CA (Onsite, eventual hybrid)Direct Hire. 26-30//hr. Talentry is looking for a Service Desk Specialist to help users resolve computer issues, as well as to perform company projects relating to IT. The right person for this role will use his or her experience providing technical...
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Control System Engineer
2 weeks ago
Carlsbad, United States Casne Engineering Full timeJob DescriptionJob Description Casne Engineering is seeking an energetic, detail-oriented person to provide controls engineering and programming services for the Engineering Services department in our Carlsbad, CA office. Candidates must exhibit a confident, professional, and positive demeanor and have a genuine interest in helping customers succeed....
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Senior Research Associate
7 days ago
Carlsbad, United States Ionis Full timeIonis Pharmaceuticals, Inc., is headquartered in Carlsbad, California, with offices in Boston, Massachusetts, and Dublin, Ireland.For more than 30 years, Ionis has been the leader in RNA-targeted therapy, pioneering new markets and changing standards of care with our novel antisense technology.Ionis currently has three marketed medicines and a premier...
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Senior Research Associate
1 week ago
Carlsbad, United States Ionis Full timeIonis Pharmaceuticals, Inc., is headquartered in Carlsbad, California, with offices in Boston, Massachusetts, and Dublin, Ireland.For more than 30 years, Ionis has been the leader in RNA-targeted therapy, pioneering new markets and changing standards of care with our novel antisense technology.Ionis currently has three marketed medicines and a premier...
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Automation Comm Specialist III
2 weeks ago
Carlsbad, United States Nes Fircroft Ltd Full timeDescription: As an Automation Comm Specialist III, you will play a crucial role in maintaining and enhancing automation and electrical systems associated with upstream onshore oil and gas production operations. Leveraging your seasoned expertise, youll provide technical support, troubleshoot network infrastructure, and contribute to process improvement. If...
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Manufacturing Operations Support Specialist
6 days ago
Carlsbad, United States Dupont Full timeEn DuPont, trabajamos en cosas que importan, ya sea en proporcionar agua limpia a más de mil millones de personas en el planeta, producir materiales esenciales en los dispositivos tecnológicos cotidianos (desde smartphones hasta vehículos eléctricos) o proteger a los trabajadores de todo el mundo. Si deseas ser parte de una empresa multindustrial líder...
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Carlsbad, United States Medtronic Full timeProvide clinical subject matter expertise to guide new product development or change development design and supporting documentation in collaboration with other functions (i.e., risk documentation, instructions for use, human factors documentation, e Clinical, Respiratory, Patient, Specialist, Clinic, Senior, Manufacturing, Healthcare
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Automation Specialist
1 month ago
Carlsbad, California, United States NES Fircroft Remote Work Freelance Full timePOSITION SUMMARY:Mid-Level Automaton Tech - Has entry level tech skills plus advanced troubleshooting skills and diagnostic skills to explain control logic functionality and solutions to system operational conditions/environments that effect performance. Starts Acquiring entry level integrator skills and uses engineering design documents to commission...
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Transportation Engineer I or II
3 weeks ago
Carlsbad, United States Turrell Engineering LLC Full timeJob Description Job Description Transportation Engineer I - II Job Description Growing civil engineering firm seeking a Transportation Engineer I or II to service sub-contracts with major engineering companies on projects for the California High Speed Rail Authority, Caltrans and LA Metro. Flexible work environment with opportunity to work remotely offered...