QA Specialist III, Lot Disposition

Oregon, United States of America

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The Position

Main Purpose of the Position:    

  • Responsible for performing batch disposition activities for products produced at Genentech's Hillsboro, OR facility in accordance with established processes and procedures, performance metrics and adherence to schedule.

  • Coordinate and communicate solutions for complex Quality System issues that impact multiple functions, working knowledge and application of cGMP regulations and standards, understanding inter-organizational impact.

Job Duties/Responsibilities:

  • Set personal performance goals and collaborate with management to establish organizational objectives

  • Manage competing priorities and allocate, adjust and optimize assigned department resources to meet department and organizational targets and timelines

  • Serve as the Quality representative on cross-functional and multi-site teams

  • Identify, design, and implement process and system improvements

  • Apply advanced theory, technical principles, and judgment to address a broad range of difficult problems

  • Notify Management of potential quality or regulatory issues that may affect product quality or regulatory compliance

  • Be accountable for behaviors as described in Genentech's Core, Common, and Critical Competencies

  • Perform any other tasks as requested by Management to support Quality oversight activities

  • Sign documents for activities as authorized and described by Genentech policies, procedures and job descriptions

  • Provide inputs for Quality reports, including summaries for Annual Product Quality Reviews

Technical Duties/Responsibilities:

  • Manage batch disposition activities to ensure that products are dispositioned in accordance with cGMPs, Regulatory, and Genentech Policies and Procedures and adherence to schedule

  • Review and approve batch release documentation

  • Review and approve change requests

  • Interface with appropriate departments to ensure that batch disposition items are complete and timely notification to Management of all known delays and significant Quality issues is provided

  • Perform reviews of investigations for potential cumulative effect to product

  • Interact with interdepartmental contacts on discrepancy/product complaint assessment, resolution, and Quality approval

  • Participate in Regulatory Inspection and Submission activities

  • Provide technical assessment and approval for controlled document changes

  • Participate in the resolution of Quality issues by fostering effective interdepartmental and cross-functional relationships

  • Train new personnel and internal customers on relevant business processes.

  • Provide input into the design and presentation of departmental performance metrics

  • Identify, design and implement process improvements

  • As Data Content Owners or backups for the master data management process, provide master data values and review and update values as necessary, applicable to Batch Disposition.

  • Manage projects related to Lot Release and/or site/network initiatives.

Qualifications: Education, Experience, Knowledge and Skills:

  • B.A. or B.S. degree (preferably in Life Science) and at least five years experience in the pharmaceutical, biotechnology or related industry or an equivalent combination of education and experience

  • At least three years of batch review or batch release experience

  • Must be capable of applying cGMP concepts and requirements to evaluate product disposition using sound judgment and decision-making skills.

  • Proven ability to interpret and relate Quality Standards for implementation and review

  • Proven ability to make sound decisions regarding scheduling, allocation of resources and managing priorities

  • Excellent ability to communicate clearly, effectively and professionally both verbally and in written form

  • Flexibility in problem solving, providing direction and work hours to meet business objectives

  • Experience with SAP strongly preferred

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.

At Genentech, we share salary ranges with applicants during the recruiting process, if requested. Third party salary estimates may not be accurate or up-to-date.

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