QA Specialist III/ Senior QA Specialist, QA Operations (HIT)

This position is part of Genentech's' Pharma Technical - individualized and cell therapy team based in Hillsboro, Oregon. In this critical role, you will be part of a dedicated cross-functional team working on production start-up activities such as the design, installation, testing, and validation of equipment, processes, and the quality approach for this exciting and novel technology.

Purpose:

• Responsible to ensure commercial and clinical (IMP) products fulfill the specified requirements and they 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 investigations 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 PT 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 technical aspects of iNeST processes, 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 at HIT 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.
• Assist in building a process for complaint management execution, including oversight of complaint intake, timely evaluation, trending and issue escalation.

Key Interfaces:

• Manufacturing, all Site functions, PTD, Affiliate Quality Assurance Management, Regulatory (PTR)
• Global Quality System and Quality Management, External Quality, Supplier Quality, partners, key suppliers and CMO

Qualifications:

• Bachelor's Degree (Pharmacy, Pharmaceutical, bioengineering, Chemistry or other relevant area preferred)
• 4 or more years work experience in the pharmaceutical or related life science industry
• A minimum of at least 4 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. Knowledge of regulations related to ATMP is desireable.
• Excellent verbal and technical written communication skills, excellent interpersonal skills, and negotiation skills are essential
• Demonstrate excellent problem solving skills, tactical strategy, and diplomacy

Preferred Skills:

• Experience with Individualized Medicine (ATMP)
• Familiarity with computer systems and ability to quickly become familiar with new software (e.g., EDMS, LIMS, SAP) is highly desirable

NOTE: This role requires on-site presence with no remote or hybrid options currently offered. During the initial 6 months, the successful candidate will be stationed at a partner site in San Diego, CA, with full coverage of temporary housing expenses provided. At the completion of the 6 months, relocation, if applicable, will be offered to the Hillsboro, OR area.

Relocation benefits to the Hillsboro, OR area are available for this posting.

#LI-CA1

#ptcareers

#cellandgenetherapycareers#

Genentech is an equal opportunity employer, and we embrace the increasingly diverse world around us. Genentech prohibits unlawful discrimination based on race, color, religion, gender, sexual orientation, gender identity or expression, national origin or ancestry, age, disability, marital status and veteran status.