Senior GxP Systems Analyst

1 week ago


Emeryville, California, United States Insight Global Full time
Job Summary

We are seeking a highly skilled GxP Systems Analyst to join our team at Insight Global. As a key member of our IT department, you will be responsible for supporting the management of GxP applications throughout the system lifecycle.

Key Responsibilities
  • Support the system administration of GxP applications in our client's environment, including Master Control, Trackwise Digital, Tracelink, Part 11 DocuSign, Veeva, and Argus.
  • Analyze, design, develop, and install GxP applications in accordance with established SOPs.
  • Provide GxP Computer System administration, escalation point, and maintenance support.
  • Prepare, review, and approve GxP Computerized Systems Validation lifecycle documents as an IT GxP SME.
  • Support analysis, resolution of Incident Management and technical investigations.
  • Follow company's change management process to comply with ITGC policies.
Requirements
  • At least 8 years of hands-on technical IT experience.
  • Minimum additional 5 years of experience supporting GxP (GMP, GLP, GCP) computerized systems in the biopharmaceutical/pharmaceutical industries.
  • Associate's degree in a related field or relevant experience.
  • Full understanding of CFR Part-11 rules and their application to regulated and validated (GxP) systems.
  • Full understanding of Computer System validation methodology.
  • Experience in requirements definition and analysis and flow charting.
  • Familiarity with System Development Lifecycle and GAMP5 methodology.
  • Excellent communication and interpersonal skills.
What We Offer

We offer a competitive benefit package, including medical, dental, and vision insurance, as well as HSA, FSA, and DCFSA account options, and 401k retirement account access with employer matching. Employees in this role are also entitled to paid sick leave and/or other paid time off as provided by applicable law.



  • Emeryville, California, United States Insight Global Full time

    Job SummaryThe Sr GxP Systems Analyst will support the management of GxP applications throughout the system lifecycle. This includes day-to-day troubleshooting, applications support, system administration, solution configuration, managing customizations, data security, data integrity GxP compliance, and CSV support.Key ResponsibilitiesSupport the system...


  • Emeryville, California, United States 4D Molecular Therapeutics Full time

    Job Summary:The Senior Manager, Quality Document Control, will oversee 4DMT's Quality Document Control Program, ensuring it is executed in an efficient, compliant, and inspection-ready manner. This role will manage the program's operations, document management, and compliance with GxP concepts and guidelines. The ideal candidate will have 8+ years of...


  • Emeryville, California, United States Kyverna Therapeutics Full time

    Job SummaryThe Document Management Senior Specialist will play a crucial role in managing and maintaining the integrity, security, and compliance of documentation within a drug development environment at Kyverna Therapeutics. This position will oversee the administration and management of the company's Document Management System (DMS) to ensure proper...


  • Emeryville, California, United States LBL Full time

    Job SummaryWe are seeking a highly skilled Senior Financial Analyst to join our team at Lawrence Berkeley National Lab's (LBNL) Office of the Chief Financial Officer Division. As a Senior Financial Analyst, you will be responsible for a wide range of complex analytical, modeling, and reporting functions.Key ResponsibilitiesDevelop, produce, and analyze...


  • Emeryville, California, United States BioSpace, Inc. Full time

    Job Title: Senior Manager, Quality Document ControlJob Summary:The Senior Manager, Quality Document Control, will oversee 4DMT's Quality Document Control Program, ensuring it is executed in an efficient, compliant, and inspection-ready manner. This role can be in-person or hybrid, with regular on-site attendance at 4DMT's Emeryville...


  • Emeryville, California, United States 4D Molecular Therapeutics Full time

    Job Summary:The Senior Manager, Quality Document Control, will oversee 4DMT's Quality Document Control Program, ensuring it is executed in an efficient, compliant, and inspection-ready manner. This role can be in-person or hybrid, with regular on-site time at 4DMT's Emeryville office.Responsibilities:Quality Document Control Operations / Document Management...


  • Emeryville, California, United States Kyverna Therapeutics Full time

    Job SummaryKyverna Therapeutics is a patient-centered, clinical-stage biopharmaceutical company focused on developing cell therapies for patients suffering from autoimmune diseases. Our team is dedicated to transforming how autoimmune diseases are treated, and we're seeking a highly skilled Document Management Specialist to join our team.The Document...


  • Emeryville, California, United States LBL Full time

    Job SummaryWe are seeking a highly skilled Business Systems Group Manager to join our team at LBL. The successful candidate will be responsible for leading the Business Systems Group, providing strategic direction and oversight to ensure the effective delivery of business systems solutions.Key ResponsibilitiesLead the Business Systems Group, providing...


  • Emeryville, California, United States BioSpace, Inc. Full time

    Job SummaryWe are seeking a highly experienced Senior Manager, Quality Document Control to join our team at BioSpace, Inc. This role will be responsible for managing our Quality Document Control Program, ensuring that all quality-controlled documents are properly reviewed, finalized, and obsoleted in an efficient, compliant, and inspection-ready manner.Key...


  • Emeryville, California, United States LHH Full time

    Job Title: Senior HR Systems Support SpecialistLHH is seeking a highly skilled Senior HR Systems Support Specialist to join our team in Emeryville, CA. As a key member of our HR team, you will play a critical role in managing the security, configuration, and upkeep of our HR systems.Key Responsibilities:Collaborate with the HRIS Manager to gain in-depth...


  • Emeryville, California, United States BeiGene Full time

    Job SummaryWe are seeking a highly skilled Learning Management System Administrator to join our team at BeiGene. The successful candidate will be responsible for providing technical support and administration of our Site-Specific training portal - learning management system (LMS).Key ResponsibilitiesSupport the global training process of the Study Specific...


  • Emeryville, California, United States Innova Solutions Full time

    Innova Solutions is seeking a highly skilled Senior Cost Accountant to join our team. **Job Summary:** The Senior Cost Accountant will play a critical role in the Accounting department, providing financial analysis and reporting to support business decisions. **Key Responsibilities:** * Analyze and interpret financial data to identify trends and areas...


  • Emeryville, California, United States National Mortgage Insurance Corporation Full time

    Job SummaryThe Financial Analyst supports the design and maintenance of critical financial and capital models, as well as expense budgeting and forecasting, treasury analytics, and ad hoc projects for investor and rating agency relations. This role will have high visibility within the company and will involve regular exposure to senior management.Key...

  • Financial Analyst

    4 weeks ago


    Emeryville, California, United States National Mortgage Insurance Corporation Full time

    Job SummaryWe are seeking a highly skilled Financial Analyst to join our team at National Mortgage Insurance Corporation. As a key member of our Financial Planning and Analysis (FP&A) team, you will play a critical role in supporting the design and maintenance of critical financial and capital models, as well as expense budgeting and forecasting, treasury...


  • Emeryville, California, United States Sutter Health Full time

    Job Title: Application Analyst IIISutter Health is seeking a highly skilled Application Analyst III to join our team. As a key member of our IT department, you will be responsible for configuring and developing Epic applications to achieve safety and efficiency goals.Responsibilities:Configure Epic applications to meet business needsDevelop and optimize Epic...


  • Emeryville, California, United States Sutter Health Full time

    Job Title: Application Analyst IVSutter Health is seeking a highly skilled Application Analyst IV to join our team. As a key member of our IT department, you will be responsible for leading the team through projects and optimization efforts, serving as an Epic expert, and educating team members and end-users on the capabilities of the Epic...

  • Compensation Analyst

    2 weeks ago


    Emeryville, California, United States Peet's Full time

    Job Title: Compensation AnalystAt Peet's, we're seeking a highly skilled Compensation Analyst to join our team. As a key member of our Human Resources department, you will play a pivotal role in managing and administering our organization's compensation programs.Key Responsibilities:Administer and maintain various compensation-related data and programs in HR...


  • Emeryville, California, United States National Mortgage Insurance Corporation Full time

    Job SummaryThe Financial Analyst I, FP&A role at National Mortgage Insurance Corporation supports the design and maintenance of critical financial and capital models, as well as expense budgeting and forecasting, treasury analytics, and ad hoc projects for investor and rating agency relations. This position requires a strong understanding of financial...


  • Emeryville, California, United States BeiGene Full time

    Job Summary:The Associate Director, DP Commercial Small Molecule role at BeiGene is responsible for ensuring the commercial small molecule products are manufactured, packed, labelled, stored and transported in a controlled way at Contract Manufacturing Organizations (CMOs) that is in accordance with the regulatory expectations and applicable Good...


  • Emeryville, California, United States Tanium Full time

    About the RoleWe are seeking a highly experienced and skilled Director of Business Systems to join our team at Tanium. As a key member of our leadership team, you will be responsible for developing and executing a vision for our Sales and Marketing technologies, ensuring they align with our business goals and objectives.The ideal candidate will have a strong...