/ Hiring

QC Scientist - IMP QC Operations

Who We Are

At the Roche Group, about 80,000 people across 150 countries are pushing back the frontiers of healthcare. Working together, we've become one of the world's leading research-focused healthcare groups. A member of the Roche Group, Genentech has been at the forefront of the biotechnology industry for more than 30 years, using human genetic information to develop novel medicines for serious and life-threatening diseases. The headquarters for Roche pharmaceutical operations in the United States, Genentech has multiple therapies on the market for cancer and other serious illnesses. Please take this opportunity to learn about Genentech, where we believe that our employees are our most important asset and are dedicated to remaining a great place to work.

The Position

Responsibilities      

• Perform Quality review and approval of method validation and qualification reports
• Perform technical and compliance review of analytical testing results for bulk, final product, pre-clinical, cell banking and stability products
• Compile analytical data for bulk, final product, pre-clinical, cell banking and stability products
• Assess and approve discrepancies of clinical and pre-clinical products
• Review and approve COA, COT and stability statements
• Technical proficiency in analytical methodology and adherence to cGMP compliance
• Train colleagues on assay review and analytical methodology as appropriate
• Identify and implement process improvements
• Accomplish corporate, operational and departmental goals
• Exert influence in the development of objectives and long range goals of the organization
• Make independent decisions around complex issues in alignment with Roche policies
• Support internal and external audits
• Work with internal departments and outside vendors, collaborators and partners concerning projects and commitments
• Meets scheduled performance of 95% on-time
• Mentor and supervise (as required) other staff members on QC related, processes and projects.

Who You Are

Job Requirements; 
• BA/BS degree in life science, or equivalent and at least ten years of relevant experience in quality control, quality assurance or equivalent experience in the pharmaceutical/biotechnology industry.

• Excellent knowledge of cGMPs or equivalent regulations and ability to interpret and relate Quality standards for implementation and review. 

• Experience working with Labware LIMS, SAP and Trackwise are preferred

• Knowledge of regulatory requirements and industry expectations for analytical method validation

• Ability to interpret and relate Quality standards for implementation and review, and apply Quality, compliance, and risk concepts to make sound technical decisions.

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

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

Genentech is an Equal Opportunity Employer.