Quality Assurance Specialist II, MQA (Night Shift)

Oregon, United States of America

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The Position

Please note this is a Night Shift position, Monday through Thursday 8:00pm to 7:00am

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 Guidelines.
  • Resolve routine Quality Assurance issues limited in scope and complexity following cGMP regulations and Genentech standards.
  • Perform assigned tasks and work to achieve company goals and department objectives.

Job Duties/Responsibilities:

  • 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. Provide guidance to peers as appropriate.
  • 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.
  • Perform QAR and issue resolution to support Tank Management as needed.
  • Initiate and close discrepancies and child 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.

Qualifications: Education, Experience, Knowledge and Skills:

(Minimum requirements)

  • B.A. or B.S. degree (preferably in Life Science)
  • 2-4 years of experience in pharmaceuticals or related field(s), or an equivalent combination of education and experience
  • 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
  • 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

Who We Are

A member of the Roche Group, Genentech has been at the forefront of the biotechnology industry for more than 40 years, using human genetic information to develop novel medicines for serious and life-threatening diseases. Genentech has multiple therapies on the market for cancer & other serious illnesses. Please take this opportunity to learn about Genentech where we believe that our employees are our most important asset & are dedicated to remaining a great place to work.

The next step is yours. To apply today, click on the "Apply online" button.

Genentech is an equal opportunity employer & prohibits unlawful discrimination based on race, color, religion, gender, sexual orientation, gender identity/expression, national origin/ancestry, age, disability, marital & veteran status. For more information about equal employment opportunity, visit our Genentech Careers page.

At Genentech, we share salary ranges with applicants during the recruiting process, if requested. Third party salary estimates may not be accurate or up-to-date.

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