Product Quality Engineer

Agilent Technologies, Inc. Boulder, CO

About the Job

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 world's most revolutionary biopharma companies are partnering with Agilent Technologies to advance the next frontier of medicine. Agilent continues to invest in the capacity and expansion of its Colorado operations. Join our team of professionals dedicated to the development and commercialization of nucleic acid therapeutics for life-changing, life-saving medicines.
 
Acts as the primary contact between external clients and Agilent departments for production support (New Product Introduction/Reintroduction, NC/CAPA, change control, Analytical Method qualification/validation and Process Validation). Assist with client/regulatory audits and regulatory inspection readiness activities. Lead client audit response teams and track client audit-related CAPAs to completion, and assist Development department in the determination of raw material and product specifications.

ESSENTIAL DUTIES AND RESPONSIBILITIES include, but are not limited to, the following:

Represent Quality in assigned product development and analytical method development projects ensuring compliance to Quality Management Systems (QMS) and external quality requirements in general, with a focus on Nonconformances (NCs), Change Control, CAPAs, SOPs.

Provide expertise, training, and/or consulting to internal teams in Quality processes and methods to build and maintain a customer-oriented quality culture (attending the client meetings and communicating the client needs to the site).

Establish and maintain active dialogue with partners and external customers with regards to product quality and quality assurance matters.

Host customer audits, coordinate the audit response teams, ensuring responses are delivered on time and filing the audit documentation.

May initiate and support QMS improvements and assure maintenance and continuous improvement of QMS procedures and systems within the area of responsibility.

Participate in product/process development/validation, project reviews, and relevant project meetings.

Review and approve product lifecycle design control documents and design changes.

Represent Design Control during regulatory inspections and customer audits with Development representatives.

Provide expertise, guidance, and training within area of responsibility to the organization.

Respond to customers and/or authorities' requests/inquiries dealing with regulations and product compliance.

Support Quality Assurance through writing, reviewing, and approving documentation and other duties as assigned.

MANAGERIAL RESPONSIBILITIES

This job has no managerial responsibilities. This position is eligible to perform the duties of the Quality Manager as the "Designee" if appropriately trained.

KNOWLEDGE, SKILLS, AND ABILITIES

1. To perform this job successfully, an individual must be able to perform each essential 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 of APIs and testing of drug products.

2. Knowledge and understanding of the oligonucleotide manufacturing or related pharmaceutical manufacturing processes.

3. Skill in time and priority management: 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

4. 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 and customer complaints and closely partner with co-workers, subordinates, and supervisors regarding product and process issues.