Close Menu

Supplier Quality Management Specialist, Quality Assurance

Organization
Agilent
Job Location
5555 Airport Blvd
Boulder, CO 80301
United States
Job Description

Job Description

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.

 

This position provides Quality Assurance (QA) oversight to Suppliers, Service Providers and Contract Labs to ensure compliance with applicable regulatory requirements and Standard Operating Procedures (SOPs).  Serves as the quality liaison to suppliers and executes and manages on-going qualification for Suppliers, Service Providers, and Contract Labs.

 

Primary Duties and Responsibilities for the Supplier Quality Management Specialist include the following:

  • Manages or supports the supplier management program.  Suggests, develops and/or implements improvements to the program to ensure it maintains compliance with current regulatory and industry expectations.
  • Performs on-site audits to ensure compliance to regulatory standards and internal procedures.  Completes audit reports and ensures appropriate CAPAs are identified by the supplier when necessary.  Site audits require up to 25% travel, both domestic and international.
  • Performs desktop audits to ensure compliance to regulatory standards.
  • Owns the Material Review Board process.  Schedules and facilitates meetings ensuring cross-functional input and decision making on supplier-related topics, including real-time monitoring of supplier performance and documentation of supplier scorecards.
  • Manages Supplier Complaints to ensure the investigation into issues are completed and appropriate CAPAs are identified and implemented by the supplier.
  • Manages the Raw Material Change Evaluation process.
  • Manages and maintains Quality Agreements with suppliers.
  • Provides input into investigations involving Supplier/Service Provider/Contract Lab deviations.
  • Responsible for writing, reviewing and/or approving documentation and procedures related to the supplier management program.
  • Provides support on various other quality assurance issues as necessary.
  • May disposition raw materials, including rejection of materials in collaboration with the Manufacturing QA team.
  • Assists with client and regulatory audits as requested by management.
  • Assists in conducting internal audits as requested by management.
Requirements

Qualifications

  • Bachelors or Master Degree or University Degree or equivalent
  • 6+ years of relevant QA experience, with 2+ years of auditing experience
  • Knowledge of GMP guidelines as well as international regulations pertaining to the production of APIs and drug products.
  • Knowledge and understanding of oligonucleotide manufacturing or related pharmaceutical manufacturing processes.
  • Experience or training in performing quality audits in a GMP environment.
  • Skill in communication, written and verbal; will be handling various relations issues and will be confronted with various interactions.
  • Ability to respond to common inquiries or complaints from Suppliers, Service Providers, Contract Labs, customers, co-workers, and supervisors regarding products, materials, and processes.
  • Ability to write reports, business correspondence, and procedures.
  • Must be a problem solver who uses advanced analytical skills to find innovative solutions to supplier quality-related systems.
  • Ability to read, analyze, and interpret industry-related periodicals, SOPs, and government regulations.
  • Skill in managing various projects; must be able to use individual discretion in completing work assignments; while assisting the group in establishing priorities, setting standards and working collectively to accomplish deadlines and objectives.
  • Knowledge of and skill in using computer software and hardware applications, including Microsoft products and the Internet.

A new report finds that women, especially women of color, are missing among the high-earners at research universities in the US, the Chronicle of Higher Education writes. 

Researcher-parents, especially mothers of small children, have lost research time during the COVID-19 pandemic, according to the Chronicle of Higher Education.

Inside Higher Ed reports that the preprint site medRxiv has taken off with the COVID-19 pandemic.

Inside Higher Ed reports some university professors are pushing back against plans for increased numbers of in-person classes for next semester.