Biotech Network Advisor, Quality Assurance

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Job Posting:
Biotech Network Advisor, Quality Assurance Position

Description:

The Quality Assurance Advisor reports directly to the Quality Executive Director and supports the Biotech Network Sites for capital project activities and supplier quality. This position will be responsible for supporting the design, engineering, commissioning, and qualification of facilities, utilities, and equipment. The role ensures compliance with the requirements of all relevant regulatory agencies. You will be responsible for advising and assisting in the review of commissioning, qualification, and validation documents supporting capital project execution.

The Quality Assurance Advisor will provide leadership and guidance to other Quality staff engaged in capital project and technology transfer activities, and support establishment/continual improvement of local business processes and procedures that align with Elanco operational standards across the Biotech Network. The role will also provide support to all sites in the network related to materials management and the supplier quality program.

Your Responsibilities:

Act as the Quality Assurance representative in all local and major capital project activities within the Biotech Network.

Participate in design, development, execution, commissioning, qualification, and validation activities for major projects. This includes, but is not limited to: definition of project scope, development and analysis of design options, establishment of user requirements, selection of appropriate equipment, construction oversight, execution of commissioning and qualification activities, and support for process validation.

Assist in defining needs for Quality Control testing laboratories and compliance needs of the same.

Ensure design and execution of capital projects consider USDA, FDA, and EMA regulatory and quality requirements; provide interpretation of standards and influence/align with local and global business partners to ensure compliant delivery.

Act as a QA subject matter expert in project teams and committees.

Review, revise, and approve relevant documentation including user requirement specifications, design specifications, DQ, SAT, FAT, IQ, OQ, PQ documents, PFDs, safety and environmental assessments, validation plans/protocols.

Support the creation, review, and implementation of quality standards and procedures for new facilities, utilities, equipment, and manufacturing processes. Establish and continually improve local business processes and systems in alignment with Elanco operational standards across the Biotech Network.

Support computer system validation activities including review and approval of validation protocols and reports.

Partner with R&D, Manufacturing, Engineering, Supply Chain, and TSMS to support the successful technology transfer of new mAb products.

Review and approve change management plans and complete/verify corresponding action…