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Quality Analyst

Cornelius, OR 97124

Posted: 11/29/2023 Job Number: 70973

Job Description

Position Type:     Quality Analyst
Location:     Hillsboro OR
Hourly rate: $28.00
Contractor benefits: Medical, vision, Dental, 401k
Job Description:
A shift which is Sun to Tue with alternating Wed (12-hrs each day) or C shift which is Thu to Sat with alternating Wed (12-hrs each day).
Working hours are 6am to 6:30pm ***

Main Purpose of the Position
* Provide direct manufacturing Quality Assurance support for all GMP activities at HTO/HDC.
* Act as a key Quality contact to manufacturing for discrepancy management, batch review, and line support.
* Assure compliance with cGMP regulations, Roche/ Genentech standards, and applicable Regulatory and Genentech standards.
* Resolve routine Quality Assurance issues limited in scope and complexity following cGMP regulations
* Perform assigned tasks and work to achieve company goals and department objectives.

Job Duties/Responsibilities
* Advocate for Roches mission of advancing and boldly championing diversity, equity, and inclusion
* Follow company policies and procedures.
* Maintain a state of inspection readiness.
* Provide input to the development of personal performance goals and departmental objectives.
* Meet assigned targets and timelines with minimal supervision.
* Prioritize assigned tasks within a fast paced environment.
* Participate in process improvement and system design teams.
* Provide assistance to customers in support of departmental functions.
* Work with colleagues to maintain cross-functional and cross-site process and procedural consistency.
* Receive specific instruction and work independently to complete tasks.
* Apply basic theory and technical principles to address routine problems.
* Troubleshoot and assist in the resolution of Quality issues by fostering effective interdepartmental and cross-functional partnerships.
* Sign documents for activities as MQA as described by Genentech policies, procedures and job descriptions.
* Be accountable for behaviors as described in Genentech’s Core, Common, and Critical Competencies.
* Perform any other tasks as requested by Management to support Quality oversight activities.

Technical Duties/Responsibilities
* Perform Inspection and Packaging AQLs. Perform Line Clearance activities in conjunction with Manufacturing.
* Initiate and close Unplanned Event (UPE) records and action/assessment records as required.
* Review batch records in the Aseptic Operations, Inspection, and Packaging areas.
* Complete Additional Actions in the Discrepancy Management System as assigned.
* Interact with interdepartmental contacts on discrepancy assessment and resolution.
* Provide Quality oversight to internal and external customers.
* Review and approve controlled documents relating to processes, equipment, facilities and utilities in the manufacture of product.
* Collaborate with departments to ensure that all review activities are executed efficiently and effectively.
* Support Quality process improvement initiatives.
* Support the execution of departmental deliverables assigned by project teams or governance teams as required.




Qualifications: Education, Experience, Knowledge and Skills
* B.A. or B.S. degree (preferably in Life Science) or equivalent in a related industry
* Ability to perform physical activity including, but not limited to lifting, standing for periods of time, and gowning
* Knowledge of cGMPs or equivalent regulations strongly preferred
* Experience reviewing manufacturing documentation
* Ability to interpret and relate Quality standards for implementation and review
* Ability to independently evaluate situations and propose potential solutions.
* Ability to communicate clearly and professionally both in writing and verbally
* Flexibility in problem solving, providing direction and work hours to meet business objectives
Must be U.S. Person for purposes of Export Compliance.
#MWL
 

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Gina D'Arcangelis

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