Quality Assurance Operations is responsible for ensuring drug substance and drug product manufacturing is conducted according to approved batch records and regulatory filings as planned and will ensure the required documentation is completed. Quality Assurance Operations provides quality oversight for Genentech’s internal manufacturing site in Philadelphia, PA and several contract manufacturing organizations that provide starting materials/raw materials, buffer solutions, bulk drug substance, formulation, aseptic filling, and packaging/labeling services for product intended for commercial and/or clinical distribution to ensure compliance with GMP’s. Quality Assurance Operations works closely with Manufacturing, Facility and Engineering, Quality Assurance Compliance, Quality Control, and others to ensure a consistent approach to ensure US/EU/ROW GMP regulations are met/maintained. This internship position is located in Philadelphia, PA, on-site. The Opportunity Develop a comprehensive Value Stream Map for activities from manufacturing through distribution for clinical and commercial product. This will provide a full visualization of the supply chain, which is essential for identifying bottlenecks and standardization opportunities across our clinical and commercial programs. Prepare process maps that will be utilized during health authority inspections and quality audits. Create a new Standard Operating Procedure (SOP) for the chain of custody of product, from manufacturing through shipment to clinical sites/distribution sites. This SOP will ensure clear handoffs and documentation requirements at each step as defined per Quality Technical Agreements and existing SOPs. Program Highlights Intensive 12-weeks, full-time (40 hours per week) paid internship. Program start dates are in May/June (Summer). A stipend, based on location, will be provided to help alleviate costs associated with the internship. Ownership of challenging and impactful business-critical projects. Work with some of the most talented people in the biotechnology industry.
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Job Type
Full-time
Career Level
Intern
Number of Employees
1,001-5,000 employees