Oregon, United States of America
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.
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
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
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.
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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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