Website genentech Genentech

*This position will require employees to be local to the Hillsboro, Oregon area. Relocation assistance might be available.

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.)

Job Summary:

·         Responsible to ensure commercial and clinical (IMP) products fulfill the specified requirements and are released in legal compliance with the customer markets, regulatory filings as well Roche quality requirements.

·         Review and approve procedures, master batch records, and other QA controlled documentation, and associated change control.

 

Key Responsibilities:

·         Responsible for lot disposition and release of commercial and clinical products according to the approved registration dossiers, ensuring internal standards are achieved and in compliance with local and international laws (e.g., Qualified Person/ Responsible Person).

·          Create or revise quality documents.  Provide Quality oversight for processes and procedures related to operations.

·         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.

·          Assess and resolve deviations to assure timely resolution. Partner with functional areas to resolve product quality impacting deviations and own CAPA related to area of responsibility.

·         Meet budget and goals for the QA Operations function.

·          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 .

 

Technical and Functional:

·                 Assure the efficient, timely, batch record review and GMP compliant product release according to schedule.

·         Provide Quality Assurance oversight throughout the end-to-end production operations including Chain of Custody and Chain of Identity, assuring current GMP compliance.

·         Keep current in training on cGMP, applicable regulations, and all areas related to core job responsibilities.

·         Participate and support internal and external audits.  Serve as Subject Matter Expert to defend lot disposition practices, batch records, and reports

·         Review and approve QA documentation to ensure GMP compliance to all relevant regulations.  Ensure documentation supports a continuously compliant state and a continual state of readiness for their areas of responsibility for agency inspections.

·         Responsible for monitoring and continuous improvement for relevant Quality key performance indicators

·         Management of deviations & CAPA, ensuring robust, thorough and complete investigations (including root cause analysis, product quality impact, interim/mitigating/long term actions and documentation).  Provide the appropriate oversight and support the implementation of the actions through appropriate records, timely resolution, action and closure of the quality system records, and their effectiveness.

·         May provide QA oversight for validation protocols and reports, including (but not limited to) methods and equipment.

·         May provide support to the Quality Systems team, as needed.  Implement and assist with improvements to Quality systems.

 

Qualifications

Education:

·         Bachelor Degree (preferably in Life Science) or other relevant area preferred.

Experience:

·         6 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

 

Knowledge/Skills/Competencies:

·             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., EDMS, LIMS, SAP, Veeva) is highly desirable.

To apply for this job please visit careers.gene.com.