QA Specialist/Senior QA Specialist, Manufacturing Quality - #1412008

The Position

Hillsboro Technical Operations (HTO) is a drug product & finished goods manufacturing organization responsible for the reliable delivery of Roche’s commercial portfolio & pipeline products. The Operations organization at HTO is divided into 2 production streams, which combine to produce millions of units of life-saving medicine every year to patients around the world.

The Opportunity:

In this exciting role, you will provide direct manufacturing quality oversight at HTO. As part of a dynamic and inclusive team, you will partner with manufacturing and other stakeholders at the site and in the network to supply patients. You will apply knowledge of aseptic drug product manufacturing processes, of health authority expectations and industry standards. You will act as a mentor and coach for the organization.

• You will act as key quality contact to manufacturing for discrepancy management, line support and batch review for commercial and launch products.
• You will provide quality oversight related to operational activities, procedures and processes. You will ensure that investigations are accurate, include appropriate corrective actions, and follow regulations, industry guidelines and company standards.
• You will apply your in-depth practical and conceptual knowledge in the manufacturing and quality functional areas at the site and within the company network.
• You will support internal cGMP audits and Health Authority inspections as a technical resource and quality subject matter expert.
• You will develop new approaches to complex problems. You will lead coordination and issue resolution across HTO Manufacturing Operations, support groups and/or projects (e.g. Operations Teams) as needed.
• You will be responsible for setting the strategic direction and framework of one or multiple programs within HTO Quality in the areas of process development, process improvement, quality and compliance. You will own the deliverables within the established programs and lead teams in their execution in line with the site strategy.
• You will be accountable for managing key operational support activities related to product transfers and new equipment/process start-up (manufacturing readiness and process design, documents, engineering runs, equipment set up, etc.).
  
  

Who you are:

• You hold a Bachelor’s degree (preferably within the Life Sciences or Engineering)
• For a QA Specialist, you have at least 5 years of experience in the pharmaceutical industry. For a Senior QA Specialist, you have at least 8 years of experience in the pharmaceutical industry.
• You are a strong problem-solver and have the demonstrated ability to troubleshoot and resolve process-related issues, ensuring efficient operations and regulatory compliance.
• You possess a deep understanding of safety, quality systems, and quality assurance concepts including the application of current Good Manufacturing Practices (cGMPs) in aseptic processing and production.
• You have a solid understanding of aseptic processing principles, regulations, and industry guidelines relevant to biologics processing, including knowledge of quality assurance principles, quality systems, microbiology, and sterility assurance.
• Your interactions exhibit tactful and effective communication skills as they often involve complex and sensitive information.
• You are able to gown into production space.
  
  

Preferred:

• You have a Master’s degree (preferably within the Life Sciences or Engineering)
• You have experience in nPFS (nested pre-filled syringe) filling
• You have experience in medical devices
  
  

The expected salary range for this position based on the primary location for this position of Hillsboro, OR is $75,000 - $139,400 for the QA Specialist level and $91,100 - $169,100 for the Senior QA Specialist. Actual pay will be determined based on experience, level, qualifications, geographic location, and other job-related factors permitted by law. A discretionary annual bonus may be available based on individual and Company performance. This position also qualifies for the benefits detailed at the link provided below.

Link to Benefits

This position is eligible for relocation benefits. It is not eligible for full time remote work arrangements.

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