Main Purpose of the Position:

• Provide day to day support to Non-Commercial Filling and Finishing Operations.

• Solve routine Manufacturing Quality Assurance and Product Release issues with broader scope and increased complexity following cGMP regulations and Genentech standards.  

• Perform assigned tasks and work to achieve company goals and department objectives.

• Perform routine Manufacturing Quality Assurance tasks to support product manufacturing and release.

• Follow company policies and procedures.

• Maintain a state of inspection readiness.

• Provide input to the development of personal performance goals and departmental objectives.

• Collaborate with Management to establish and meet targets and timelines.

• Independently manage competing priorities with limited instruction.

• Serve as a Quality representative on cross-functional and multi-site teams.

• Identify and recommend solutions to potential procedure, process and system gaps.

• Provide assistance to customers in support of departmental functions.

• Participate in the design and implementation of department and cross-functional initiatives.

• Apply basic theory and technical principles to address moderately complex problems.

• Troubleshoot and initiate the resolution of Quality issues by fostering effective interdepartmental and cross-functional partnerships.

• Serve as a technical subject matter expert (SME) in support of department functions.

• Sign documents for activities as authorized and 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:

• Evaluate and close complex, non-investigational discrepancies.

• Initiate discrepancy investigations as required.

• Draft and route discrepancy summaries to Discrepancy Management.  

• Perform Assessor and Evaluation activities defined in the Discrepancy Management System (DMS).  

• Review and close completed evaluations and perform additional activities as warranted in the Discrepancy Management Systems (DMS).

• Review, edit and approve controlled documents.

• Assess and summarize complex process deviations.

• Collaborate with internal and external departments on MQA and Product Release projects and commitments.

• Monitor MQA activities to evaluate trends, and report repetitive anomalies, observations, and discrepancies to Management.

• Represent MQA at cross-functional meetings to develop, review, and approve Commercial Quality documents.  

• Independently manage daily activities in order to meet standard lead times.

• B.A. or B.S. degree (preferably in Life Science) and at least two years experience in the pharmaceutical, biopharmaceutical or related industry, or an equivalent combination of education and experience

• Knowledge of cGMPs or equivalent regulations strongly preferred

• Ability to interpret Quality standards for implementation

• Ability to independently evaluate situations and propose potential solutions

• Ability to interpret Quality standards for implementation

• Ability to communicate clearly and professionally both in writing and verbally

• Flexibility in problem solving and work hours to meet business objectives