Quality Systems Specialist

4 weeks ago


Richmond, California, United States TCWGlobal Full time

Job Summary

We are seeking a highly skilled Quality Systems Specialist to join our team at TCWGlobal. As a key member of our Northern California Quality Assurance Operations team, you will play a critical role in supporting manufacturing activities, including investigations of product non-conformance and deviations, blocking of non-conforming material, batch record and CoA review and release.

About the Role

As a Quality Systems Specialist, you will leverage your knowledge of Quality principles to guide manufacturing partners in the correct path for cause investigation and issue resolution. You will provide feedback on best practices for documentation and Quality record updates to reinforce our Quality Management System.

Key Responsibilities

- Support company's top business priority: 3110 BioPharma Demand
- Support batch release for LSG mfg sites
- Support Veeva integration for NorCal (Change Control, Nonconformance Management)
- Verification of Change Control activities
- Rapid containment of product quality issues (either from manufacturing issue or a customer complaint issue)
- Audit preparedness, to reduce audit findings

Requirements

- Associate degree or equivalent in Biology, Chemistry, or related field
- 2+ years' experience in a Regulated Manufacturing industry within Medical Devise/Drug/ Or Biotech
- Understanding of GMP/ISO regulations (ISO 13485, MDSAP, FDA 820/210/211)
- Working knowledge of device/drug/biotech manufacturing processes
- Detail-oriented, excellent organization and project management skills and ability to multitask
- Decision making, time management, organization, communication, leadership, and computer skills
- Proficient in Microsoft Office, Visio and Excel
- Salesforce and SAP experience is a plus



  • Richmond, California, United States Aloden, Inc. Full time

    Data Quality Specialist is responsible for ensuring the integrity of data used for business operations and decision-making processes. This role will analyze, monitor, and improve data quality across various systems and databases.Key responsibilities include:Collaborating with business partners to understand data quality standards, policies, and procedures to...


  • Richmond, California, United States Cynet Systems Full time

    Job Description:At Cynet Systems, we are seeking a highly skilled OEBS Technology Functional Specialist to support and enhance mid-size Oracle OEBS solutions. This role requires collaboration with various groups within the IT department and business units to ensure the appropriate level of quality is provided in the OEBS solutions.Key Responsibilities:...


  • Richmond, California, United States gpac Full time

    Electrical Systems SpecialistAt GPAC, we are seeking a skilled Electrical Systems Specialist to join our team. As an Electrical Systems Specialist, you will be responsible for analyzing and assessing lighting systems for optimal visibility and efficiency. You will also develop grounding systems to ensure safety and compliance with industry standards....


  • Richmond, California, United States Commonwealth of Virginia Full time

    Job Title: Quality Assurance SpecialistJob Summary: We are seeking a Quality Assurance Specialist to join our team at {company}.Responsibilities:• Conduct thorough testing and quality control measures• Identify and report defects and issues• Collaborate with development teams to implement quality improvementsRequirements:• Bachelor’s degree in...


  • Richmond, California, United States DuPont Full time

    Job SummaryDuPont is seeking a highly skilled Control Systems Specialist to join our team. As a Control Systems Specialist, you will be responsible for configuring and maintaining components of the control system, including network security tasks such as managing user access, endpoint security deployment, and vulnerability management.Key...


  • Richmond, California, United States Cynet Systems Full time

    Job Description: As an experienced AV technician, you will be responsible for setting up, using, organizing, and installing media equipment such as projectors, microphones, video monitors, and sound-boards. You should have advanced knowledge of audio and video equipment, including video conferencing equipment and services. Excellent troubleshooting and...


  • Richmond, California, United States Cynet Systems Full time

    Job Title: IT Financial Operations SpecialistJob Summary: We are seeking an IT Financial Operations Specialist to support the fiscal, budgetary, and accounting operations for IT at Cynet Systems.Key Responsibilities:* Support the development of the annual plan for the agency's IT budget requests* Manage the department's expenditures* Analyze projects,...


  • Richmond, California, United States Cynet Systems Full time

    Job Description:Cynet Systems is seeking a highly skilled Senior Technical Support Specialist to join our team. As a key member of our IT Operations Center, you will be responsible for establishing and maintaining our communications systems, ensuring seamless connectivity and data transmission.Key Responsibilities:Program voice and data telecommunications...


  • Richmond, California, United States Abb Holdings Inc Full time

    We are seeking a highly motivated and detail-oriented Quality Assurance Specialist to join our team at ABB. As a Quality Assurance Specialist, you will be responsible for collaborating with various teams to support ABB's operations, ensuring effective coordination and successful project completion within defined timelines.You will utilize your understanding...


  • Richmond, California, United States Integrated Resources Full time

    Job Title: Business Systems Documentation SpecialistLocation: Hybrid (at least 3 days onsite per week)Duration: 9+ monthsInterview: In-personJob Description:At Integrated Resources, we are seeking a skilled Business Systems Documentation Specialist to join our team. The ideal candidate will have 6+ years of experience in systems documentation, including...


  • Richmond, California, United States Demo - Maximus Full time

    Job SummaryWe are seeking a highly skilled Quality Assurance Specialist to join our team at Demo - Maximus. As a Quality Assurance Specialist, you will be responsible for monitoring, evaluating, and directing staff members on the quality of work performed as measured against project standards, contractual requirements, and performance measures.Key...


  • Richmond, California, United States T2 Systems Full time

    Job Summary: We are seeking a highly skilled Embedded Systems Field Technician to join our team at T2 Systems. As a key member of our technical support team, you will be responsible for facilitating the implementation of PARCS hardware and software, providing ongoing direct support to our customers, and troubleshooting technical problems related to software,...


  • Richmond, California, United States Cynet Systems Full time

    Job Title: Senior Quality Assurance AnalystJob Summary:Cynet Systems is seeking a highly skilled Senior Quality Assurance Analyst to join our team. As a Senior Quality Assurance Analyst, you will be responsible for ensuring the quality of our software applications by developing and executing test plans, identifying and reporting defects, and collaborating...


  • Richmond, California, United States NSC Technologies Full time

    Job Title: Security Systems SpecialistLocation: Richmond, VAPosition Summary:NSC Technologies is seeking a skilled Security Systems Specialist to install and service access control, CCTV, and surveillance systems.Able to lead teams or a crew in the installation and implementation of new equipment, or perform service for equipment or system repairs. Position...


  • Richmond, California, United States Lorven Technologies Full time

    Job SummaryAt Lorven Technologies, we are seeking a highly skilled Technical Systems Specialist to join our team. As a Technical Systems Specialist, you will be responsible for maintaining the health of the Ivanti Endpoint Manager environment, supporting software packaging and distribution, and providing tier 3 level software support.Key Responsibilities...


  • Richmond, California, United States Cynet Systems Full time

    Job Description:As a key member of the Cynet Systems team, the Senior Technical Solutions Specialist will be responsible for specifying and designing technical solutions, demonstrating competence in developing solutions in cooperation with the customer. This role requires excellent communication skills, including written and verbal, with the ability to...


  • Richmond, California, United States Virginia Commonwealth University Health Systems Full time

    Acute Care Surgical Services Job DescriptionVirginia Commonwealth University Health Systems is seeking a skilled Surgical Nurse Specialist to join our team in Acute Care Surgical Services. As a key member of our healthcare team, you will provide high-quality patient care and contribute to the development of our surgical services.Job SummaryThe Surgical Nurse...


  • Richmond, California, United States Virginia Commonwealth University Full time

    Job SummaryVirginia Commonwealth University's Facilities Management Department is seeking a skilled Electrical and Ventilation Trades Specialist to join its Facilities Operations team. The successful candidate will utilize their knowledge of electrical and mechanical trades to perform preventive maintenance, repair, and installation of building...


  • Richmond, California, United States Virginia Commonwealth University Health Systems Full time

    Job SummaryVirginia Commonwealth University Health Systems is seeking a skilled Surgical Nurse Specialist to join our team in Acute Care Surgical Services. As a key member of our healthcare team, you will provide high-quality patient care and contribute to the development of our surgical services.Responsibilities• Provide direct patient care and education...


  • Richmond, California, United States CGL Facility Management, LLC Full time

    Job SummaryCGL Facility Management, LLC is seeking a skilled Electronics Systems Specialist to join our team. As a key member of our maintenance team, you will be responsible for ensuring the optimal performance of all electronic systems and computerized controls within our facilities.Key Responsibilities Execute preventive maintenance schedules in a timely...