What are the responsibilities and job description for the QC Associate position at Genentech?
The QC Associate position is in the QC Adventitious Agents Testing group. The primary focus of the position is testing of in-process samples for the presence of adventitious agents (i.e., virus, Leptospira and mycoplasma contamination) using growth-, cell culture- and PCR-based methods as well as participating in or leading the validation of associated methods. Secondary to testing and validation responsibilities, the role will support QC AAT’s cell culture lab that maintains cell lines and produces cultures for assays.
In this role, you will support a global customer base of the Roche CHO DS network, including Roche sites and CMOs, for both commercial and clinical products.
Responsibilities
Perform adventitious agent testing of process samples from throughout the Roche/Genentech network.
Perform a range of assays that use growth media (traditional mycoplasma testing), cell cultures (general viral screening) and PCR (MycoTool and ViroTool).
Maintain lab equipment and coordinate lifecycle activities (e.g., qualification, repair and decommissioning).
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. Design training material as necessary.
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.
Identify and lead process improvements and develop resolution of gaps of moderate complexity with limited supervision.
Actively participate and lead group and project teamwork; project and process improvements
Perform any other tasks as requested by Management to support Quality activities
Prepare and maintain reagents per established procedures.
Coordinate with suppliers and customers to support complex, cross-functional operational activities.
Work to meet schedules.
Support the maintenance and compliance of operational areas.
Perform final review of assay datasheets
Perform testing and protocol/report authoring for the validation of QC AAT methods under limited supervision.
Identify and propose resolutions for discrepancies. With limited supervision, design and execute remediations as needed
Work with area experts to understand and resolve complex and/or atypical issues.
Actively identify opportunities and develop solutions for continual improvement in testing and lab operations.
Work holidays and weekends as needed (infrequent).
Qualifications
The right candidate will possess the following skills and experience:
Bachelor’s degree, preferably in a science-related discipline.
2+ years of experience in a related role in pharma/biotech; 1+ years with an advanced degree.
Good oral and written communication skills with experience in technical document authorship.
Continuous improvement mindset.
Experience in QC testing and mammalian cell culture preferred.
*This position is not eligible for relocation. Only local candidates will be considered.
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