About the Company: Nivagen is a global company dedicated to enhancing lives by developing and providing cost-effective generic prescription drugs and over-the-counter products for the North American market. For over a decade, we've remained steadfast in our commitment to the core values of excellence, integrity, and respect for people. Our team of professionals collaborates tirelessly to pioneer advancements in manufacturing, distribution, and quality control, ensuring a holistic approach to healthcare. Through vertical integration of the pharmaceutical supply chain, cutting-edge technology, and unwavering dedication to excellence, we continually strive to redefine medication accessibility and affordability. We prioritize our employees' well-being by offering competitive pay, comprehensive benefits, and robust training and development opportunities. By investing in our workforce and fostering a culture of growth and support, we empower our team to drive innovation and make a positive impact in the healthcare industry. At Nivagen, our mission is clear: to make a meaningful difference in people's lives by delivering high-quality, affordable medications while upholding the highest standards of integrity and excellence. Job Location: Nivagen Pharmaceuticals, Sacramento, CA 3900 Duckhorn Dr, Sacramento, CA 95834 About the Job: Nivagen Pharmaceuticals is seeking a Document Control & Training Manager to lead the document control and GMP training programs across all quality and manufacturing operations. This is a managerial role responsible for overseeing SOP lifecycle management, training program development and execution, regulatory compliance of controlled documents, and supervision of Document Control Specialists and Training Coordinators within a sterile pharmaceutical manufacturing environment. The ideal candidate is a hands-on leader who can build scalable document control and training systems from the ground up while maintaining compliance with FDA/cGMP an
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U.S. Person status required, as defined by ITAR (22 CFR 120.15). Active DoD Secret clearance required (minimum); Top Secret eligibility required. About the Role Systems Technology, Inc. (STI) is seeking a Facility Security Officer / IT Security Administrator to serve as the company's designated FSO of record and to manage the classified IT systems that support our NISPOM-governed defense programs. This is a hands-on, dual-hatted role at a growing facility — you'll run day-to-day industrial security operations (classified document control, personnel security, foreign visit processing) while also owning the security posture of the IT systems and networks that touch controlled and classified information. What You'll Do Security Operations & Program Execution Serve as STI's Facility Security Officer of record, executing daily collateral security operations under NISPOM (32 CFR Part 117) Maintain classified document control, accountability, and safeguarding procedures Support classified facility operations and any Restricted Areas Personnel Security & Onboarding Process personnel security clearance requests and maintain records in DISS/NISS Facilitate new hire security onboarding and deliver initial and annual security training/briefings Foreign Visits & External Engagements Process, disclose, and host foreign visits in accordance with NISPOM Coordinate with program and engineering teams to ensure compliant execution of visits and classified meetings Technology Control & IT Security Own and administer Technology Control Plans (TCPs) and ITAR/EAR compliance controls for controlled technical data Manage security configuration, access control, and monitoring for IT systems handling classified or export-controlled information Serve as (or support) the Information System Security Officer/Manager (ISSO/ISSM) function for accredited classified IT systems Administer user accounts, permissions, and audit logging on classified and controlled networks in coor
POSITION SUMMARY: Works closely with manager to ensure company and team goals are met. Ensures high quality work is completed timely. PRIMARY RESPONSIBILITIES: • Responsible for day-to-day staffing / scheduling / setting up sample run schedules. • Ensures production work is consistently completed according to department goals. • Ensures all case samples are processed and accounted for. • High proficiency working within one or more laboratory information systems to ensure all relevant data is correct. • Monitors cases reaching promised TAT and identify issue / cause / reason for those cases. Work with managers and other departments as needed to prevent future incident. • Updates SOPs to accurately reflect current practices and works with manager and Document Control / QA / Training team to make effective. • Monitors team members to ensure adherence to SOPs and safety procedures • Oversees training for new hires: works in conjunction with lead to train new hires. • Investigates / follows up on lab errors ( NCR ) . • Assists manager in initiating and completing CAPAS. • Handles employee issues. Collaborates with Manager to resolve issues. • Ensures alignment with team for reasoning behind instructions / processes, changes that are made, why certain ideas cannot be implemented effectively. • Meets regularly with individual team members to discuss goals and progress. • Responsible for staff performance reviews. • Plans and leads shift meetings • Adheres to Departmental Expectations • Ensures compliance with all regulatory agency requirements through documentation, audits, and corrective action. • Go-to person when manager is not present . • May assist lab team in day to day tasks • Keeps team morale up and maintains professionalism of team members, including by acting as role model. • Approves timecards an
Pharmacy Production Manager – Band 7 Location: Hull Training Hospital Start Date: ASAP Duration: Ongoing Hourly Rate: £30–£31 per hour Working Hours: Full‑time (Mon–Fri) Job Overview We are seeking an experienced Pharmacy Production Manager (Band 7) to join the team at Hull Training Hospital. You will play a key role within the MIRC department, working closely with Quality Control and Production Managers to ensure the safe, compliant and efficient production of radiopharmaceuticals and blood cell labelling. This position would suit a registered Pharmacist or a healthcare scientist/technical professional with suitable experience in radiopharmacy, production, QC, or related technical disciplines. Key Responsibilities Assist in the safe production of radiopharmaceuticals and blood cell labelling. Carry out QC activities on complex scientific equipment and manufactured products. Operate and support processes involving cyclotron equipment and hot cells. Analyse QC results, take appropriate corrective action and document findings. Participate in the manufacturing and dispensing of specialist radiopharmacy products. Supervise, train and assess competencies of staff across multiple disciplines. Maintain high standards of safety, accuracy and regulatory compliance. Work autonomously in an environment involving direct contact with radioactive materials and blood. Qualifications & Experience Qualified Pharmacist or Healthcare Technical/Scientific professional with relevant radiopharmacy or GMP production experience. Strong background in QC, production processes or specialist technical duties. Experience with radiopharmaceuticals, aseptic manufacturing, or cyclotron operations is highly desirable. Ability to supervise and train others effectively. High level of responsibility, accuracy and professional autonomy. Why Choose Pulse Competitive hourly pay Dedicated consultant support Quick and smooth onboarding process Opportunities for continued professional development How to
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”).
Abbott is a global healthcare leader that helps people live more fully at all stages of life. Our portfolio of life-changing technologies spans the spectrum of healthcare, with leading businesses and products in diagnostics, medical devices, nutritionals and branded generic medicines. Our 115,000 colleagues serve people in more than 160 countries. JOB DESCRIPTION: Position Overview The Senior Clinical Laboratory Scientist will be responsible for performing moderate and high complexity laboratory testing on patient specimens, interpreting and reporting patient results, performing quality control and quality assurance procedures, assisting Laboratory Leadership with advanced laboratory duties, and complying with all applicable local, state, and federal laboratory requirements. The Senior Clinical Laboratory Scientist will continually display excellent initiative in all aspects of their work, contribute to projects and discussions in addition to daily laboratory testing and consistently performing to high standards. Leadership is demonstrated in technical troubleshooting of laboratory instrumentation and processes as well as laboratory quality improvements, health and safety, and training of laboratory staff. Essential Duties include but are not limited to : Perform moderate and highly complex laboratory tests, procedures, and analyses according to the laboratory’s standard operating procedures with minimal supervision. Perform, review, and document laboratory quality control procedures. Identify potential problems, determine potential solutions, and take appropriate action in order to maintain a high level of quality in test processes and results. Achieve and maintain competency on laboratory tasks. Participate in research, validation, and/or implementation of new procedures and/or technologies. Mainta
The Accounting/Finance IT Project Manager leads delivery of financial systems initiatives across Accounting, Finance, Treasury, AP, Tax, Internal Controls, and FP&A. This role converts finance and accounting needs into requirements, project plans, and measurable outcomes, while managing scope, timeline, budget, and cross-functional coordination from initiation through go-live. Prior Accounting/Finance experience is required to evaluate process impacts, manage risk, and drive adoption across enterprise financial platforms. This role is based at Topgolf HQ in Dallas, TX, with an expectation of four days per week in the office and one day remote. Responsibilities Governance: Establish operating cadence, roadmap visibility, prioritization, decision logs, risks, and executive-ready updates for Finance/Accounting technology work. Requirements & Business Cases: Partner with functional leaders to document pain points, future-state needs, savings opportunities, and success measures before work begins. Delivery: Coordinate delivery across SAP, OneStream, Anaplan, Coupa, Concur, Pathlock, Workday, and Crunchtime, tax, treasury, billing, and reporting platforms, owning scope, dependencies, testing, cutover, and release readiness end-to-end. Stakeholder Facilitation: Lead working sessions across IT, Accounting, Finance, Operations, vendors, and business owners to resolve roadblocks and align on scope and timelines. Controls & Adoption: Ensure projects account for accounting controls, SOX/access impacts, data integrity, training, UAT, and post-go-live adoption. Reporting: Track capacity, vendor involvement, dependencies, benefits, and risk, reprioritizing as business needs shift. Artifacts: Create and maintain project charters, plans, schedules, and RAID logs across 2-3 concurrent projects. PMO Alignment:</b
Our vision is to transform how the world uses information to enrich life for all . Micron Technology is a world leader in innovating memory and storage solutions that accelerate the transformation of information into intelligence, inspiring the world to learn, communicate and advance faster than ever. The Senior Structured Data Access Control Process Analyst will play an important role in supporting Micron's Structured Data Access Control (sDAC) program and related data governance initiatives. This role analyzes business processes, identifies opportunities for automation and efficiency, develops reporting and dashboard solutions, supports operational workloads, and contributes to projects that strengthen secure and compliant access to enterprise structured data. The successful candidate will combine strong analytical thinking with process improvement, stakeholder engagement, reporting, and project execution skills. Working closely with technical and business teams, they will transform complex governance processes into actionable insights and help drive continuous improvements across access management and governance workflows. This position supports both day-to-day operations and strategic initiatives, helping advance governance modernization, workflow automation, and user experience improvements across the organization. Responsibilities Develop and maintain a deep understanding of Structured Data Access Control (SDAC) process and related governance workflows along with the knowledge of Role Based Access Control (RBAC) and data security management for integration. Define, document and improve business processes, requirements, workflows, operating procedures, governance standards, user guidance, training material and communications. Identify opportunities f
The following description is not intended as an exhaustive list of all responsibilities, duties and skills required of personnel so classified. Management retains the discretion of adding or changing the duties of the position at any time. Job Summary: The Safety Technician is responsible for several activities, including waste consolidation, segregation, and preparation for shipping/disposal. The technician will perform facility inspections which include machine shops, production work areas, warehouse, and office workspaces; along with providing recommendations for corrective actions. The Technician will perform safety training on a variety of topics to employees and review the company's policies and procedures to ensure that the operational processes adhere to the internal guidelines and federal, state, and local regulations. The safety technician must have excellent communication, organizational, and computer skills. The primary tasks, duties, and responsibilities that usually make up the job description of a Safety technician are shown below: Essential Duties and Responsibilities Inspect work areas and equipment to ensure compliance with company, state, and federal safety policies and regulations; cite dangerous areas and processes and recommend corrective action. Distribute and track issuance of PPE to company staff according to employee role, tasks, and department. Monitor company PPE inventory and replenish supplies accordingly. Prepare, distribute, and post various health and safety material and announcements. Assist in spill clean-up as needed. Design and implement workplace processes and procedures that help protect workers from hazardous work conditions. Conduct new hire safety orientation and training. Maintain SDS (MSDS) formal document library; update SDS’s as needed. Maintain the Company Dashboard and applicable OSHA occupational injury logs and report safety statistics as required. Coordinates clean-up or remediation activities at facilities. Assist
The Global Clinical Supply (GCS) Automation Solutions Specialist will leverage qualified automation platforms to design and maintain forms, templates, and workflows across a broad range of projects that advance the business digital transformation goals. For this position, candidates will need to be well versed in workflow digitization/automation tools and techniques, familiar with the Microsoft suite of applications, operate independently, be a creative problem solver, and have a willingness to continuously learn in order to successfully deliver optimal solutions across a diverse and dynamic portfolio. This role requires providing support across other global time zones based on business need, specifically from 8:00 p.m. to 5:00 a.m Philippine Time or 9:00 p.m. to 6:00 a.m. Philippine Time (equivalent to 8:00 a.m. to 5:00 p.m. U. S. Eastern Time). Role Responsibilities Perform implementation and maintenance of Document Automation, and Workflow Business Enablement solutions Implement GCS SharePoint Sites and SharePoint based workflows using PowerApps / Power Automate Work with business Subject Matter Experts (SMEs) and Business Analysts (BAs) to ensure requirements are well defined and understood In partnership with Digital, support all aspects of the system change control process (prioritization of new functionality, definition of user requirements, User Acceptance Testing, System Development Lifecycle document reviews, etc) Create visually engaging presentation and training materials, process flows and guidance documents that enhance business use of technology Provide ongoing business support to business users Monitor utilization of core digitization solutions and regularly report usage metrics Identify opportunities for continuous improvement and lead or participate on projects that enhance GCS systems and processes Provide innovative insights
Job Details: Job Description: The Role and Impact As a Director, Global IT, you will play a critical role in driving complex, high-impact projects that underpin the success of Intel's technology solutions and services. You will manage end-to-end execution, overseeing project plans, resources, and timelines to deliver innovative outcomes. Your expertise will ensure seamless coordination across teams, fostering collaboration and enabling Intel to meet strategic objectives efficiently. Business Group You will join Intel's Global IT organization, a team committed to accelerating enterprise-wide innovation and operational excellence. This group is responsible for delivering technology solutions and services that empower Intel to achieve its business goals while driving efficiency and transformation across the company. Key Responsibilities - Lead large-scale technology projects and programs, ensuring alignment with business objectives, timelines, and resource allocations. - Develop detailed project plans, including scope, schedule, budget, and risk management strategies. - Manage implementation processes, including testing, documentation, training, and change control, to guarantee project success. - Collaborate across teams to assess dependencies, remove roadblocks, and address constraints impacting delivery. - Establish and drive program governance, including milestones, risk mitigation plans, and executive-level reporting. - Monitor program health metrics to ensure quality, timeliness, and adherence to project goals. - Conduct project closeout assessments and document lessons learned for continuous improvement. Qualifications: Minimum Qualifications - Bachelor's degree in Business, Engineer
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