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Sr. Specialist, Quality Systems

Emeryville, CA 94608

Posted: 07/09/2024 Employment Type: Contract Job Number: 608915 Is job remote?: No Country: United States

Job Description

A mid-sized life science company is looking to add a Senior Specialist, Quality Systems to their team for the next six months (possible contact to hire opportunity).  In this role, you will be providing quality expertise to support our clients Quality’s team for the development and commercialization of products in compliance with relevant US, EU and ICH requirements. The Sr Specialist, Quality Systems role will support in the execution, development, and continuous improvement of the Document Control/Management and Training Program as the company grows and matures organizationally.

Ideal candidates will have prior experience partnering with internal departments to support Document Control (eDMS), Learning Management System (LMS), Quality Management Systems (eQMS), and to implement process improvements to meet business and regulatory requirements. This position will report to the Associate Director, Quality Systems.

  • Bachelor’s degree in computer science, Life Science or related field
  • 4+ years in Quality Systems/Quality Assurance experience in the life sciences industry.
  • Experience in the use of validated computer systems for management of regulated documents and training, including electronic records and electronic signatures.
  • Thorough knowledge of electronic Quality Management Systems, Learning Management Systems and Quality Documentation Systems, admin experience
  • Participate in system validation activities, as required
  • Experience developing improvements to electronic Quality Systems.
  • Experience with Dot Compliance, preferred.

  • Supports the day-to-day management of the Quality Systems department, including areas such as Document Control and Training. 
  • Assist with the development and implementation of controlled documents including, but not limited to: SOPs, Work Instructions, training materials, protocols, reports, templates, and reference guides.
  • Maintain internal formatting standards and ensure all documentation is formatted accordingly. Formatting may include creating templates, fonts and style, pagination and numbering and any other activities required to achieve document requirements.
  • Assist with the Quality training program including collaborating with department managers to develop training requirements and training plans.
  • Create and maintain GxP training files and matrices.
  • Generate compliance metrics and prepare routine KPI reports.
  • Assists in delivery, maintenance, and continuous improvement of GxP processes in eDMS, eLMS, and eQMS.
  • Adhere to all cGMPs, compliance/regulatory mandates and quality requirements.
  • Build and maintain relationships with other departments and establish a culture of engagement and transparency with Quality.
  • Strong software proficiency with Microsoft Suite and other desktop applications.
  • Ability to manage multiple projects in a dynamic environment with attention to detail.
  • A well organized, self-motivated and independent work style with the ability to initiate and follow through on expected duties.
  • Excellent written and verbal communication and collaboration skills with the ability to interact with all levels throughout the organization.
  • An equivalent combination of education and experience may be accepted as a satisfactory substitute for the specific education and experience listed above.
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About Emeryville, CA

Discover your next career opportunity in lively Emeryville, California. This vibrant city nestled in the heart of the San Francisco Bay Area offers a unique blend of artistic charm and entrepreneurial spirit. With a bustling job market and access to iconic landmarks like the Bay Street Shopping Center, Emeryville is a hub for innovation and growth. Enjoy delectable global cuisine, explore local art galleries, catch a show at the nearby Fox Theater, or cheer on the Golden State Warriors at the Chase Center. Embrace the dynamic culture and endless possibilities that Emeryville has to offer. Dive into our job listings today and take a step towards an exciting career in this thriving region!

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