Senior Quality Assurance Specialist
2 days ago
Job Title: Senior Quality Analyst
Job Summary:
We are seeking a highly skilled Senior Quality Analyst to join our team at Randstad Life Sciences US. 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 for Positron Emission Tomography (PET) products.
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 the 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.
- Work closely with cross-functional teams, including senior management levels, to ensure the company maintains high-quality suppliers and provides appropriate supplier feedback.
- 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.
- Actively demonstrate the values of accountability, quality, customer service, efficiency, collaboration, and safety.
- Travel expectation: 10-20%.
- This position is site-based and requires a presence on-site three days per week.
Requirements:
- 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:
- 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.
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