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For your reference, we have included the original job posting below.
Senior QA Specialist
Job Number:
23770373
Company Name:
Genentech
Job Location:
Hillsboro, OR US
Job Category:
Healthcare & Medical
Senior QA Specialist
Senior QA Specialist
Job ID Requisition Number 1 Location Hillsboro, OR Job Category Quality. Shift Day
Description Main Purpose of the Position: The successful incumbent will be responsible for performing lot disposition activities for products produced at Genentech's Hillsboro, OR facility in accordance with established processes and procedures, performance metrics and adherence to schedule. This position requires the refined ability to coordinate and communicate solutions for complex Quality System issues that impact multiple functions, working knowledge and application of cGMP regulations and standards, and an understanding of inter-organizational impact. The incumbent will also support Quality sponsored development and investigational activities related to Automated and Manual Visual Inspection, Filling, Packaging, and Primary Container studies. Versatility is a must as this position will support ongoing start-up activities at the new site. This position requires a high motivation to perform assigned work to achieve company goals and department objectives. This position will be dayshift and located in Hillsboro, OR. 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 supportQuality oversight activities *Sign documents for activities as authorized and described by Genentech policies, procedures and job descriptions.
Technical Duties/Responsibilites: *Manage lot 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 lot release documentation *Review and approve change requires in the change control system *Interface with appropriate departments to ensure that lot 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 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 *Participate in Quality sponsored development and investigational activities related to Automated and Manual Visual Inspection, Filling, Packaging, and Primary Container studies
Qualifications: Education, Experience, Knowledge and Skills (Minimum Requirements): · B.A. or B.S. degree (preferably in Life Science) and at least 5 years experience in the pharmaceutical, biotechnology or related industry or an equivalent combination of education and experience. (at least 8 years experience required Sr QA Specialist level) · At least 1 year of lot 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
