QA Specialist, BIologics

About this role

<p>At Roche you can show up as yourself, embraced for the unique qualities you bring. Our culture encourages personal expression, open dialogue, and genuine connections, where you are valued, accepted and respected for who you are, allowing you to thrive both personally and professionally. This is how we aim to prevent, stop and cure diseases and ensure everyone has access to healthcare today and for generations to come

Join Roche, where every voice matters.</p><h3></h3><p></p><h3>The Position</h3><p><span><b>Quality and Technical Guidance</b></span></p><ul><li><p><span>Oversee programs to support Visual Inspection Operations at the Drug Product facility.</span></p></li><li><p><span>Execute daily operations, including, but limited to:</span></p><ul><li><p><span>Providing Quality Oversight and guidance during on-the-floor manufacturing</span></p></li><li><p><span>Executing daily on-the-floor duties to ensure facilities, equipment, materials, and documentation comply with SOPs and safety standards.</span></p></li><li><p><span>Performing Quarantine and Segregation of material.</span></p></li><li><p><span>Performing line clearances activities.</span></p></li><li><p><span>Perform Acceptable Quality Level (AQL).</span></p></li></ul></li><li><p><span>Review procedures, documents and records, including but not limited to Batch Production Records, and Protocols.</span></p></li><li><p><span>Ensure that EBR/Batch Records are complete, accurate, and documented according to the written procedure. Quality support in electronic batch record creation, review, and approval.</span></p></li><li><p><span>Author/Review/ Quality documents, such as Standard Operating Procedures (SOP’s), Risk Assessment (RA), training materials, training documents, protocols and reports.</span></p></li><li><p><span>Support and represent QA during audits and inspections; may directly interact with regulatory agencies during on-site inspections.</span></p></li><li><p><span>Identification and implementation

Apply for this role on Roche’s official careers site.