QA Specialist, CSV

Arena Pharmaceuticals | San Diego, California, United States

Posted Date 5/03/2021
Description

The opportunity

This is an exciting time to join Arena Pharmaceuticals, a clinical stage biotechnology pharmaceutical company with a robust portfolio of assets across multiple therapeutic areas.

We are seeking a QA Specialist, CSV reporting to the QA Engineer, CSV.  This individual will perform day to day CSV activities to ensure compliance with Policies, SOPs, WIs, to support compliance with global regulations and standards set forth by governing regulatory and accrediting agencies.

 

What you’ll dive into

  • Business system assessments and supporting the GxP business system inventory in close collaboration with IT.
  • Provide guidance to system and process owners for GxP business system change control and related CSV activities/deliverables for the control of system implementations, upgrades, new version releases, retirement, etc.
  • Supporting IT infrastructure qualification and control.
  • Serving as the CSV lead on selected GxP business system projects.
  • Authoring/review validation deviations when needed.
  • Performing periodic review of active systems and identify and address gaps found.
  • Author/review documents related to retirement of legacy systems, e.g., retirement plan and report, guide process owner in data archival and retrieval.
  • Authoring/review documents related to data migration, e.g., data migration plan and report.
  • Author/review documents related to retirement of legacy systems, e.g., retirement plan and report, guide process owner in data archival and retrieval.
  • Using applicable CSV checklists, questionnaires, and templates.

 

What we expect

  • Working knowledge of GxP regulations and CSV principles, including, but not limited to 21 CFR Part 11, Part 210/211, Annex 11, GAMP 5, and Data Integrity.
  • Understanding of GAMP5 principles and guidance.
  • Understanding the implementation and management of cloud/SaaS business systems.
  • Author/review validation plans, protocols (IQ/OQ/PQ), test scripts, and reports.
  • Author/review validation documents, such as, but not limited to: system assessment, user requirement specifications, traceability matrix, migration plan/report, configuration specification, retirement plan/report, etc.
  • Can perform risk and impact assessments, rate risk/criticality of user requirements/functional requirements; apply a risk-based approach to CSV.
  • Execute protocols using Good Documentation Practices (GDPs) and in compliance with company procedures.
  • Author, investigate and resolve protocol deviations and/or discrepancies.
  • Provide guidance on account administration and definition of roles/rights commensurate with training level.
  • Assist process owners with generation of system administration and general user SOPs.
  • Support CSV remediation projects as needed.

 

Minimum qualifications

  • BS degree in a technical discipline (computer science, engineering, or similar) with 5+ years related CSV experience in GxP-regulated biotech/pharmaceutical industries.
  • Ability to handle multiple projects simultaneously and to prioritize tasks in a dynamic environment.
  • Ability to speak effectively and communicate directly with all levels of personnel in a positive and collaborative manner.
  • Must possess excellent communication skills, both verbal and written.
  • Strong self-motivation as well as the ability to work independently, and in a team environment with minimum supervision.
  • Ability to interpret a variety of instructions furnished in written, oral, diagram, or schedule form.
  • Strong follow-up and organizational skills.
  • Ability to identify situations which will require management intervention for resolution.
  • A highly driven, detail-oriented person is essential for this position.
  • Must possess proficient knowledge of Microsoft Word, Excel, and other systems such as Smartsheet, SharePoint, etc.
  • Must be able to maintain confidentiality.

 

What you’ll get

  • To be a part a growing company and fantastic team passionate about developing novel drug therapies to improve people’s lives.
  • Opportunities to learn and contribute creative solutions.
  • Comprehensive health insurance.
  • Matching 401k retirement plan.
  • Paid time off and holidays.
  • Company celebrations.

 

Arena celebrates and supports our differences and is proud to be an Equal Employment Opportunity and Affirmative Action Workplace. We do not discriminate based upon race, religion, color, national origin, gender (including pregnancy, childbirth, or related medical conditions), sexual orientation, gender identity, gender expression, age, status as a protected veteran, status as an individual with a disability, or other applicable legally protected characteristics. Arena is committed to providing reasonable accommodations for qualified individuals with disabilities and disabled veterans in our job application procedures. If you need assistance due to a disability, you may contact us at jobs@arenapharm.com.

 

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