South San Francisco
California, United States of America
Develop solutions to complex issues and Quality initiatives that impact the goals and objectives of the organization related to QC testing following cGMP regulations and Genentech standards. Perform environmental monitoring of facilities and utility systems and microbiological testing of cell banks, in-process material, and final products; data review; and/or related activities that support QC operations.
Job Responsibilities (general)
Follow company policies and procedures
Maintain accountability for deliverables affecting department and organizational objectives
Accountable for exhibiting behaviors as described Genentech/Roche Core Competencies.
Maintain a state of inspection readiness
Receive and provide training
Identify gaps in systems and procedures
Identify and support resolution of technical problems
Assure and apply GMP throughout operations
Supports department to meet corporate goals and department objectives
Provide quality oversight support to internal/external customers
Ensures the integration of environmental health, safety, and security into the business processes, systems, and programs while reporting safety and environmental incidents including injuries, illnesses, and safety suggestions within one’s functional area.
Perform any other tasks as requested by Management to support Quality activities
Job Responsibilities (specific)
Perform a broad variety of basic and moderately complex tests with documentation according to GMP
Review data and assess against established acceptance criteria for basic to moderately complex methods.
Prepare and maintain reagents per established procedures.
Coordinate with customers to support basic to moderately complex operational activities.
Work to meet schedules.
Job Knowledge & Scope
Applies a complete understanding of theories and concepts from one's technical/professional discipline to independently address a broad range of difficult problems.
May determine methods and procedures on new assignments.
Job Complexity & Decision Making
Solves a wide range of difficult problems in imaginative ways.
Demonstrates judgment in selecting methods and techniques for obtaining solutions.
Participates in developing courses of action that may impact multiple functions in the organization.
Participate in assay transfer and/or assay validation as needed
Receive and provide basic to moderately complex training. Assist in design of training material as necessary.
Works under only very general supervision and guidance, with more detailed instructions on new assignments.
Works with manager to establish priorities and timelines.
Identification and Remediation of Issues
Identify discrepancies and propose actions for remediation.
Identify and support resolution of basic to moderately complex technical problems.
Actively participate in group and project teamwork; project and process improvements
Support the maintenance and compliance of operational areas.
Support compliance audits.
Networks with senior internal and external personnel in own area of expertise.
Represents organization on assigned projects.
Experience and Education
BS / Masters Degree in Microbiology and 5+ years of experience in a Pharmaceutical Microbiology lab
Experience with rapid/automated microbiological methods and assay validation
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.
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