Senior/Quality Systems Specialist

Job Locations US-CA-South San Francisco
ID
2022-1070
Category
Quality Assurance
Position Type
Regular Full-Time

About Us

Nkarta Therapeutics is a publicly traded (Nkarta NKTX symbol), South San Francisco headquartered, early-stage biopharmaceutical company focused on the discovery, development and commercialization of allogeneic, off-the-shelf engineered natural killer, or NK, cell therapies to treat cancer.

Founded in 2015 at the birthplace of biotechnology, our development pipeline of engineered NK cell therapy candidates includes two co-lead clinical programs, NKX101 and NKX019. Clinical trials for 101 are in process; 019 will begin in H2 2021. Nkarta recently announced a collaboration with CRISPR Therapeutics, a world leader in gene-based medicines, for the development and commercialization of up to three new cell therapy candidates and access to clinically validated CRISPR/Cas9 genome engineering.

 

Complementing our broad research and development capabilities, Nkarta has also built an extensive cell therapy manufacturing operation.  We have a 2,700-square foot clinical good manufacturing practice, or cGMP, facility on-site at our primary corporate location in South San Francisco, California. We plan to start in-house manufacturing of NKX019 in 2021 and NKX101 in 2022. We are also currently designing a separate, larger cGMP facility, to supply our anticipated pivotal clinical trial and commercial needs.

Overview

Nkarta offers a unique opportunity for a highly motivated QA Specialist to join our growing Quality Assurance team.  This role will be integral in building, automating and continuous improving the GxP Quality Management Systems. It will oversee activities related to the operation, efficiency, and compliance of quality systems and programs such as Deviation Management, CAPA, Change Control, Data Integrity, Metrics, Vendor Management and Audits, Internal Audits, and Management Review.

Responsibilities

  • Subject Matter Expert (SME) for investigational systems, operational mechanisms, and e-Quality Management Systems (eQMS) (e.g., QT9).
  • Create, review and/or approve QMS records (e.g., Deviations, CAPAs, Change Controls, etc.).
  • Perform escalation/impact assessments for Quality System records (e.g., Deviations/CAPAs, Change Controls, and Supplier Corrective Action Requests (SCAR) and Supplier Notice of Change) in alignment with procedural requirements.
  • Implement processes and procedures to support e-QMS module deployment (e.g., QT9 and LearnaboutGMP).
  • Develop Quality Systems training materials and facilitate training to build cross-functional capabilities across the organization.
  • Function as System Owner/Site Administrator for e-QMS modules to support user account administration and validation activities.
  • Review and or approve validation deliverables/documentation during the validation process (e.g., validation plans, user requirements, risk assessments, functional specifications, traceability matrices, installation qualification, operational qualification, user acceptance testing, performance qualification and validation summary reports).
  • Review and approve proposed changes to GxP systems and determine the necessary regulatory requirements to maintain the computerized system in a validated state of compliance.
  • Actively support internal and external audits.
  • Develop, review and present key performance indicators (KPIs) and quality metrics to Senior Management via operating mechanisms (e.g., Management Review).
  • Other tasks as assigned by Management.

Qualifications

  • Thorough understanding of current good manufacturing practices (GMP) and ability to apply them to Nkarta’s environment.
  • Strong MS Office skills (Word, PowerPoint, Excel, and SharePoint) and general computer skills.
  • Proven ability to work effectively cross functionality.
  • Strong verbal and written communication skills to communicate effectively with groups and individuals; ability to initiate as well as respond.
  • A competent, effective presenter of training materials.
  • Good analytical and creative problem-solving skills. Able to create plans to resolve issues and mitigate risks.
  • Independence and comfort working in the fluid structure of start-up biotech.
  • Willingness and ability to travel up to 10%.
  • Embodies the Nkarta culture of empowerment, diversity, and inclusion.

Preferred

  • Previous experience with the implementation of electronic management systems and 21CFR Part11 is a plus
  • Quality Assurance experience supporting both development and commercial products is a plus.
  • Previous experience with QT9 is a plus.

 

Education / Background

  • A minimum of a Bachelor's degree.
  • 5+ years related experience in pharmaceutical/biotech.
  • Established working knowledge of current Good Manufacturing Practices and other applicable regulations.
  • Previous experience with regulatory audits (i.e., FDA).

 

Work Environment / Physical Demands

 

This position requires the ability to occasionally lift and/or move up to 25 pounds. The common requirements of an office environment (computers, computer screens, workstations, etc.) apply. Car and airplane travel might be required for this role.

Working at Nkarta Inc.

The 130+ team members describe working at Nkarta through some of the following comments. While getting better work-life balance and improving communications between groups in an early stage start up environment are two areas in which we’re working, here are real anonymous comments of why people think Nkarta is a great place to work.

 

  • People are always open to ideas. This company provides a safe place for its employees (covid testing, etc.)”
  • Exceptionally talented, committed, *kind* & supportive team”
  • The CEO is transparent and honest with expectations for the whole company. There is genuine care amongst the leadership team for their peers and employees. I believe this is unique.”
  • Not to sound corny, but the emphasis on people as a valuable resource is something I  recognize doesn't often exist elsewhere, and it's here in ample supply, which is great.”
  • It's the first place that I've worked where the executive team truly values the employees. It's a pretty amazing thing not to hear that employees can be replaced with someone new. Institutional knowledge is understood.”
  • We have a very diverse team with executives that are friendly and accessible.”
  • Smart and dedicated colleagues. Mission to make a difference in patients lives. Empower us with tools needed to succeed.  Open and transparent culture. Transparent leadership. Handling of covid and running the company was done very well.”

 

To learn more about our work at Nkarta and the career opportunities that will drive us forward to serve patients, please visit the company’s website at https://www.nkartatx.com

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