QA Specialist III, Change Control (HTO)

United States of America, Oregon, Hillsboro

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QA Specialist III, Change Control (HTO)

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

At Roche, 94,000 people across 100 countries are pushing back the frontiers of healthcare. Working together, we’ve become one of the world’s leading research-focused healthcare groups. Our success is built on innovation, curiosity and diversity

Roche is an equal opportunity employer.

Quality, Quality > Quality AssuranceHillsboro