Quality Assurance (QA) Lead for Chemical Standards Manufacturing

Agilent inspires and supports discoveries that advance the quality of life. We provide life science, diagnostic, and applied market laboratories worldwide with instruments, services, consumables, applications, and expertise. Agilent enables customers to gain the answers and insights they seek - so they can do what they do best: improve the world around us. Information about Agilent is available at www.agilent.com.

The Chemistries & Supplies Division develops, manufactures, procures, and supports state-of-the-art consumables including liquid- and gas-phase separation columns, sample preparation, chemical standards, performance chemicals, glycobiology and bioanalytical proteins, and a full portfolio of supplies for life science instrumentation.

Our Global Quality & Regulatory Affairs organization owns and maintains a robust ISO 9001 Quality Management System (QMS) for use by all functions in the division. The organization is also responsible for maintaining hardware and chemical/biological regulatory compliance, where applicable. Our Product Support organization assists customer and field service as well as providing customer feedback insights to the division. Our organization leads and supports continuous improvements to ensure compliance and efficiency.

The manufacturing site for this position produces chemical standards, including reference materials certified to ISO 17034 and validated under ISO 17025, controlled substances registered with the Drug Enforcement Agency (DEA). This position offers a hybrid working location requiring at least three (3) days per week on site.

The Quality Assurance Lead for the site is responsible for:

• Owning and improving the division and local ISO 9001 QMS including alignment to Agilent- and group-level QMS.

• Ensuring the QMS meets the following additional needs:

  • ISO 17034 for the site as a Reference Material (RM) Producer, and

  • ISO 17025 for the site as a Testing and Calibration Laboratory, and

  • Manufacturer of DEA controlled substances.

• Monitoring customer feedback, non-conformance, and operational performance metrics to identify trends and driving corrective actions and continuous improvements, as appropriate.

• Representing Quality Assurance on cross-functional teams for the Product Lifecycle and Design Control.

• Creating and conducting quality training with proper effectiveness verification and traceability. Collaborating with cross-functional division and site leads to ensuring the organization is sufficiently trained.

• Leading Corrective and Preventative Action (CAPA) program at the division and site level.

• Preparing and communicating division and local quality reviews including customer complaints (defects on arrival, warranty, product safety events, customer surveys, etc.), achievements and customer satisfiers, and proactive change notification.

• Leading external (registrar and customer) and internal audits as well as regular site-evaluation assessments. Tracking audit findings and collaborating with site management to develop corrective action plans and drive to closure.

• Upon request, managing customer quality and change control agreements, questionnaires, and Supplier Corrective Action Reports (SCAR). Leading customer communication to ensure quality and contractual compliance.

• Partnering with Regulatory Affairs to understand and implement requirements such as Safety, Electromagnetic Compatibility (EMC), Materials of Concern (MoC), Environmental Health and Safety (EHS), Safety Data Sheet (SDS), etc.

• Partnering with Product Support to gather and analyze customer feedback to identify and implement corrective actions, corrections, and continuous improvement.

• University degree, or equivalent, in Chemistry, Life Sciences, Engineering, or related field.

• 4+ years' experience with Quality Assurance, ISO Compliance, and/or Quality Management Systems.

• Experience with ISO 9001:2015, or similar, required.

• Experience with ISO 17034:2016, or similar, required.

• Experience with ISO 17025:2017, or similar, required.

• Knowledge of DEA controlled substances preferred.

• Familiarity with the Corrective and Preventive Action process (CAPA) required.

• Analytical skills (Root Cause Analysis (RCA), Six Sigma, MSA, Failure Modes and Effects Analysis (FMEA)) knowledge preferred.

• Experience and practical application of Continuous Improvement tools and mindset preferred.

• Effective communication skills and ability to work independently and collaborate with cross-functional and global teams.

Additional Details