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Senior Quality Assurance Specialist

2 months ago


Reston, Virginia, United States Randstad USA Full time

About the Role

We are seeking a highly skilled Senior Quality Assurance Specialist to join our team at Randstad USA. As a key member of our quality assurance team, you will be responsible for maintaining supplier performance metrics, developing trend data of supplier-related processes, and conducting audits of external suppliers.

Key Responsibilities

  • Review and approve supplier deviations, change controls, Corrective and Preventive Actions (CAPAs), and Out of Specification (OOS) investigations.
  • Monitor supplier quality events utilizing Quality System, as appropriate.
  • Partner with technical Subject Matter Experts to assess product/system/validation impact.
  • Maintain supplier performance metrics and develop trend data of supplier-related processes.
  • Communicate data to senior management and suppliers, as appropriate.
  • Lead investigations and assure follow-up and corrective action closure to reduce and eliminate supplier-related defects.
  • Conduct audits of external suppliers, as needed.
  • Lead teams/projects related to supplier complaint investigation, corrective actions, and quality system excellence.
  • Recommend and implement improvements to the supplier quality program induced by new regulations, agency guidance documents, industry standards, new technologies, and internal needs.
  • Prepare, maintain, and review supplier quality procedures to assure compliance with customer and local, state, federal, and international regulations.
  • Ensure operational, functional, and compliance excellence.
  • Maintain supplier performance metrics, develop trend data of supplier-related processes.
  • Monitor supplier quality events utilizing the Quality System.
  • Travel expectation: 10-20%.

Requirements

To be successful in this role, you will need:

  • Bachelor's degree in a related medical, science, or engineering discipline.
  • 2+ years working in the pharmaceutical industry.
  • 2+ years in a Quality role.
  • Excellent written and verbal communication skills.
  • Exceptional influencing, partnership, and collaboration skills.
  • Proficient with Microsoft Office applications, including SharePoint.
  • Excellent oral and written skills.
  • Teamwork and collaboration skills.
  • Strong attention to detail.

Preferred Qualifications

We are looking for candidates with:

  • Experience in automating data processes and workflows using tools such as Power BI, SharePoint, Microsoft Access and Excel, and related technologies.
  • Experience using an electronic QMS (eQMS).
  • Experience performing audits of third-party laboratories.
  • Knowledge of US cGMP, ICH requirements, ISO 9001, US regulatory regulations.
  • Experienced in Positron Emission Tomography (PET) manufacturing and aseptic manufacturing, including strong technical understanding of aseptic manufacturing processes, equipment and facilities requirements.