QA Specialist III, Change Control (HTO)

Oregon, United States of America

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The Position

Main Purpose of the Position:

  • Function as a Change Controller by assessing, reviewing, approving and closing change records.
  • Review and approve change control lot clearance documentation.
  • Author, edit, word process, and release controlled documents relating to Quality Systems.
  • File, track, retrieve, scan, and archive documents and records in accordance to Document and Records Management policies and procedures.
  • Provide training to new employees and internal customers on policies and procedures for the Change and Document Control systems.
  • Participate in Quality systems deployment and process improvement initiatives.
  • Collaborate with departments to ensure that all review activities are executed efficiently and effectively.
  • Support periodic audits and regulatory inspections.
  • Develop and implement systems to ensure inspection readiness.
  • Ensure discrepancies and CAPAs relevant to the Change Control system are thoroughly identified, defined and properly assessed.
  • Provide data for departmental performance metrics.
  • Serve as a Quality representative on cross-functional and multi-site teams.


Job Duties/Responsibilities:

  • Support continuous improvement and implementation of best practices for site and network Change Control through implementation of Lean Production System methodologies.
  • Serve as presenter for Change Control System during agency inspections as needed
  • Support continuous improvement of the Change Control process and Change Control Quality System Health.
  • Support Quality Systems Reporting team execution of PQS, APQR, QSMR and Quality Metrics, as required.
  • Troubleshoot and support the resolution of Quality issues by fostering effective interdepartmental and cross-functional partnerships.
  • Train personnel and internal customers on relevant business processes.
  • Be accountable for behaviors as described in Genentech's Competencies.
  • Provide input into the design and presentation of Change Control performance metrics.
  • Must be able to work independently, organize and manage projects by demonstrating progress against defined milestones and schedules.


Technical Duties/Responsibilities:

  • Support the Change Control process by assessing, reviewing, approving and closing change records.
  • Provide input to revised and new policies and procedures to effectively guide change control efforts.
  • Collaborate with departments to ensure change control activities are executed efficiently and effectively.
  • Represent Quality Systems and Validation on multi-disciplinary project teams, as required.

Qualifications: Education, Experience, Knowledge and Skills:

(Minimum requirements)

  • B.A. or B.S. degree (preferably in Life Science) and at least five years experience in the pharmaceutical or biopharmaceutical industry, or an equivalent combination of education and experience.
  • Highly self-motivated, well organized, and able to develop alternative solutions to issues
  • Ability to work collaboratively in cross-functional teams to achieve milestones and goals.
  • Ability to interpret and relate Quality standards for implementation and review.
  • Ability to make sound decisions about quality and technical subjects.
  • Ability to communicate clearly and professionally both in writing and verbally.
  • Exhibits sound knowledge of cGMPs or equivalent regulations
  • Flexibility in problem solving and work hours to meet business objectives

Who We Are

A member of the Roche Group, Genentech has been at the forefront of the biotechnology industry for more than 40 years, using human genetic information to develop novel medicines for serious and life-threatening diseases. Genentech has multiple therapies on the market for cancer & other serious illnesses. Please take this opportunity to learn about Genentech where we believe that our employees are our most important asset & are dedicated to remaining a great place to work.

The next step is yours. To apply today, click on the "Apply online" button.

Genentech is an equal opportunity employer & prohibits unlawful discrimination based on race, color, religion, gender, sexual orientation, gender identity/expression, national origin/ancestry, age, disability, marital & veteran status. For more information about equal employment opportunity, visit our Genentech Careers page.

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