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Quality Assurance Specialist III

2 months ago

Brea, California, United States American Regent, Inc. Full time

Job Summary

The Quality Systems Specialist III will play a critical role in ensuring the quality and integrity of our sterile pharmaceutical products. This position will be responsible for investigating and documenting non-routine events, identifying trends, and providing support for internal audits.

Key Responsibilities

  • Investigate and document non-routine events associated with the manufacture of sterile pharmaceuticals, ensuring compliance with company SOPs, policies, and cGMPs.
  • Identify trends and evaluate metrics to support internal audits, working under the direction of the QS Manager.
  • Facilitate and lead high-risk or complex investigations involving multiple investigation areas.
  • Review Quality Systems data for trends and report to functional area management, QA, and QS Manager/Supervisor.
  • Implement and verify corrective action plans in accordance with company SOPs, policies, and cGMPs.
  • Collaborate with QS staff, colleagues, and leadership to ensure goals and objectives are accomplished in a timely manner.

Requirements

  • Bachelor's Degree required; Quality certification preferred (e.g., ASQ).
  • 5+ years of quality assurance experience in an FDA-regulated environment required.
  • Six-sigma yellow or green belt certification preferred.
  • Demonstrated analytical and critical thinking skills.
  • Knowledge of applicable FDA regulations and expertise in interpreting and applying to the organization required.
  • Excellent English communication skills, both oral and written, and comprehension required.
  • Direct experience investigating issues during cGMP activities and summarizing investigations in written format required.
  • Demonstrable experience in root cause analysis, impact assessment, and risk management required.
  • Exceptional organization and time management skills, with proven ability to multitask efficiently.
  • Detail-oriented person with ability to work independently, accurately, and assess priorities.
  • Ability to respond quickly to problems or changes in priorities and work with a team to effect solutions.
  • Ability to work in a team environment and act as a key resource for colleagues, providing technical mentorship within the team and cross-function settings.
  • Advanced computer skills, including Microsoft Word, Excel, Access, Visio, or comparable software, PowerPoint, and email.
  • Understanding of the pharmaceutical process pathway and how each discipline interacts and their respective needs to achieve success.

Benefits

American Regent offers a competitive total rewards package, including healthcare, life insurance, profit sharing, paid time off, matching 401(k), and a wide range of other benefits.

American Regent celebrates diversity and is committed to creating an inclusive environment for all employees. We are an Equal Opportunity Employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability status, or protected veteran status.