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Senior Product Quality Engineer

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.

 

You have honed your knowledge, functional breadth and technical skills. This is your opportunity to join our Quality Engineering team! Here, you'll implement your vision by transforming broad concepts and business strategies into structured projects, lead the design and delivery of new programs and provide solutions to sophisticated, high-impact issues.

 

DUTIES AND RESPONSIBILITIES:

  • Represent Agilent's interests and requirements in the negotiations with clients. Partners with internal and external customers to obtain approvals for agreements with clients.
  • Establishes and maintains an active dialogue with partners and clients with regard to product quality and Quality Assurance matters
  • Represent Quality Assurance in assigned product development and analytical method development projects ensuring compliance to NASD Quality Management Systems (QMS) and external Quality Technical Agreements (QTAs) in general, with a focus on Nonconformances (NCs), Change Control, Design Control, Risk Management, and Validation.
  • Provide direction and training in Quality processes and methods to build and maintain a customer-oriented quality culture. Attending client meetings and communicate the client needs to the site.
  • Lead and/or participate in client audits, coordinating the audit response teams, ensuring responses are delivered on time and filing the audit documentation.
  • Represent Design Assurance (design control/changes in Product Lifecycle) during regulatory inspections with Development representatives, as needed.
  • Approve change controls, SOPs, Master Batch Records, Analytical protocols and reports, Batch Analytical Records, API Specifications, nonconformances, and CAPAs.
  • Initiate and support NASD QMS improvements and assure maintenance and continuous improvement of NASD QMS procedures and systems.
  • Participate in product development, project review meetings, and relevant project meetings.
  • Support the QA role in product investigation meetings when needed.
  • Provide knowledge, development, and training within the area of responsibility to the organization.
  • Respond to customers and/or authorities' requests/inquiries.
  • Assist in PAI readiness activities and assists with preparation sessions for Agilent NASD staff.
  • Support Quality Assurance oversight through writing, reviewing, and approving documentation, and other duties as assigned.

Knowledge, skills, and abilities

To perform this job successfully, an individual must be able to perform each crucial duty satisfactorily. The requirements listed below are representative of the knowledge, skill, and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

  • Demonstrated strong technical writing and communication (written and verbal) skills focused on customer service and continuous process/program improvements.
  • Knowledge of GMP guidelines as well as international regulations pertaining to the production and testing of APIs.
  • Knowledge and understanding of oligonucleotide manufacturing or related pharmaceutical manufacturing processes.
  • Knowledge of and skill in using computer software and hardware applications, including Microsoft Office products and the Internet.
  • Skill in time and priority management; uses individual discretion in completing work assignments; while assisting the group in prioritizing, setting standards and working collectively to meet goals and objectives.
  • Ability to read, analyze, and interpret industry-related periodicals, SOPs, and government regulations. Ability to write clear and concise reports, business correspondence, and procedures. Ability to respond to common inquiries or complaints from customers, co-workers, subordinates, and supervisors regarding the products and processes.
Requirements

QualificationsEDUCATION and/or EXPERIENCE

  • Bachelor's degree (B.S.) or equivalent in chemistry or related life-sciences field and 8+ years related experience and/or training; or equivalent combination of education and experience.
  • Prior experience and/or training working in a GMP production environment
  • Pharmaceutical, biotech or medical device-related experience

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