We are seeking a Senior Quality Analyst to maintain supplier performance metrics, develop trend data of supplier related processes, log and track supplier quality events utilizing the Quality System, and conduct audits of external suppliers for Positron Emission Tomography (PET) products.
Key Responsibilities/Essential Functions
Duties and Responsibilities:
Reviews and approves supplier deviations, change controls, Corrective and Preventive Actions (CAPAs), and Out of Specification (OOS) investigations.
Monitors supplier quality events utilizing the Quality System, as appropriate.
Partners with technical Subject Matter Experts to assess product/system/validation impact.
Maintains supplier performance metrics and develops trend data of supplier-related processes.
Communicates data to senior management and suppliers, as appropriate.
Leads investigations and assures follow up and corrective action closure to reduce and eliminate supplier related defects.
Conduct audits of external suppliers, as needed.
Leads teams/projects related to supplier complaint investigation, corrective actions, and quality system excellence.
Recommends and implements improvements to the supplier quality program induced by new regulations, agency guidance documents, industry standards, new technologies, and internal needs.
Prepares, maintains, and reviews supplier quality procedures to assure compliance with customer and local, state, federal, and international regulations.
Works closely with cross-functional teams, including senior management levels, to ensure they maintains high-quality suppliers and provides appropriate supplier feedback.
Ensures operational, functional, and compliance excellence.
Maintains supplier performance metrics, develops trend data of supplier related processes.
Monitors supplier quality events utilizing the Quality System.
Actively demonstrates 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.
Basic Qualifications:
Bachelor's degree is required 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.
Other Requirements (preferred):
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.