Job Title: QA Specialist III / Sr. QA Specialist
Department: Quality Systems and Compliance
Reports To: Head of Quality Systems and Compliance
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. We believe every employee makes a difference. We are passionate about transforming patients’ lives. We are courageous in both decision and action, we believe that good business means a better world.
The focus of Hillsboro Technical Operations (HTO) is Drug Product manufacturing (Component Prep & Compounding, Liquid/Lyophilized Filling, Automated/Manual Inspection, Packaging/Finished Products and Distribution.)
Main Purpose of the Position:
Site capability lead for Planned Events (PE), Corrective Action / Preventative Action
Partner with functional CAPA owners, ensuring robust, thorough and complete CAPA records. Provide the appropriate oversight and support the implementation of the actions, timely resolution, and closure of the quality system records to ensure their effectiveness.
Partner with Squad, Global PE CAPA team and network sites to drive continuous system health at HTO.
Participate and support internal and external audits. Serve as Subject Matter Expert to defend quality system practices and records.
Define, monitor, and continuously improve relevant Quality key performance indicators.
Responsibilities (Technical and Functional):
Support continuous improvement and implementation of best practices for site and network through implementation of Lean Production System methodologies.
Provide input to the development of personal performance goals and departmental objectives.
Collaborate with Management to establish and meet targets and timelines.
Independently manage competing priorities with limited instruction.
Serve as a Quality representative on cross-functional and multi-site teams.
Identify and recommend solutions to potential procedure, process and system gaps.
Provide assistance to customers in support of departmental functions.
Participate in the design and implementation of department and cross-functional initiatives.
Troubleshoot and initiate the resolution of Quality issues by fostering effective interdepartmental and cross-functional partnerships.
Be accountable for behaviors as described in Genentech’s Core, Common, and Critical Competencies.
Support and lead cross-functional projects and Quality initiatives. Identify and participate in the resolution of Quality risks and issues by fostering effective interdepartmental and cross-functional relations.
Meet budget and departmental goals for Quality Systems and Compliance.
Engage in proactive measures to promote a positive safety culture while meeting all applicable Safety, Health and Environment requirements in alignment with corporate policy and local legal requirements
Embody lean principles and methods while fostering a continuous improvement mindset.
Provide support to the Quality Systems and Compliance team, as needed. Implement and assist with improvements to Quality system
Bachelor Degree (preferably in Life Science) or other relevant area preferred.
8 or more years work experience in the pharmaceutical or related life science industry
A minimum of at least 6 years of experience in Quality Assurance, Quality Control, Manufacturing, or equivalent experience
Expert knowledge of Quality Assurance principles, practices and standards for the biopharmaceutical industry
Expert knowledge of GMP relevant to the pharmaceutical industry; knowledge of the local and international GMP regulations.
Excellent verbal and technical written communication skills, excellent interpersonal skills, and negotiation skills are essential.
Demonstrate excellent problem solving skills, tactical strategy, and diplomacy.
Familiarity with computer systems and ability to quickly become familiar with new software (e.g., Veeva, EDMS, SAP) is highly desirable.
To apply for this job please visit careers.gene.com.