À propos de ce poste QC Analyst II/III Reviewer (Contract) chez Adverum
Adverum Biotechnologies, Inc., wholly owned subsidiary of Eli Lilly and Company, is a mission-driven clinical-stage company that aims to establish gene therapy as a new standard of care for highly prevalent ocular diseases with the aspiration of developing functional cures to restore vision and prevent blindness. Leveraging the research capabilities of its proprietary intravitreal (IVT) platform, Adverum is developing durable, single-administration therapies designed to be delivered in physicians’ offices to eliminate the need for frequent ocular injections to treat these diseases. By overcoming the challenges associated with current treatment paradigms for these debilitating ocular diseases, Adverum aspires to transform the standard of care, preserve vision, and create a profound societal impact around the globe.
Note to Recruiters and Agencies
All recruiter and agency inquiries must go through Adverum’s internal Talent Acquisition team. Unsolicited resumes sent to Adverum will be considered Adverum's property. Adverum’s Talent Acquisition team must expressly engage agencies for any requisition. Direct contact with hiring managers by agencies will not be tolerated and may affect your ability to work with Adverum in the future.
Adverum is seeking a dedicated Quality Control Analyst to be a part of our vibrant team based in our Redwood City office. Reporting variably to the Quality Control Manager, Quality Control Lead, or as a part of a project hierarchy, this role will engage collaboratively with the QC team and other cross-functional teams. As a vital member of the Quality Control unit, the analyst will play a significant role in advancing and performing Quality Control (QC) review of different assay techniques, systems, policies, processes, procedures, and controls pertinent to the analytical examination of clinical materials.
What You’ll Do:
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Perform QC review of release, stability, and in-process testing documentation and data to ensure compliance with GxP requirements.
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Review, analyze, and verify analytical data for drug substance and finished product testing, ensuring accuracy, completeness, reliability, and data integrity.
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Provide technical expertise in the review of analytical methods, assay execution, and troubleshooting activities within the QC laboratory, with particular focus on qPCR, Potency, ELISA, SEC and related techniques.
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Review and follow SOPs, test methods, specifications, and controlled documents; support the revision and continuous improvement of QC procedures to maintain compliance.
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Review completed testing records, sample documentation, and final result packages for release, stability, and in-process studies prior to approval.
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Identify, document, and own deviations through closure, including support for investigations, impact assessments, root cause analysis, and corrective actions as needed.
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Support qualification and validation activities through protocol and report review, documentation assessment, and verification of compliance with approved requirements.
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Support QC investigations, assay lifecycle activities, and nonclinical sample review as needed, collaborating cross-functionally to resolve quality and compliance issues.
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Provide guidance to junior staff, apply sound quality judgment in daily review activities, and communicate effectively with internal teams and external testing laboratories.
About You :
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Bachelor’s degree in biology, chemistry, Biochemistry, or a related field, with a minimum of 3-5 years of experience (QC II) or 3-5 years’ experience (QC III), preferable in a bio-pharma analytical laboratory setting
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Proficient in QC review of analytical documentation, including test records, data packages, instrument printouts, and associated documentation generated from systems such as Empower, SoftMax Pro and related laboratory software.
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Experience reviewing analytical methods, raw data, and supporting documentation for techniques such as Potency, qPCR, SEC, SDS-PAGE, DLS, and similar assays in a regulated laboratory environment.
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Experience in quality control documentation review is required based on level, with a strong understanding of compliance expectations, good documentation practices, and analytical record assessment; a solid foundation in molecular biology is desired.
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Experience with viral vector (adeno-associated virus) products is a plus.
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Must possess knowledge of cGMPs and regulatory prerequisites concerning the biotechnology and pharmaceutical sectors.
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Familiarity with statistical methods applicable to the analysis of experimental data.
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Proficiency in general and non-routine laboratory skills.
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Exceptional interpersonal, communication, and organizational skills are a must.
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Proficiency in MS Office and equipment-related software like Soft Max Pro is desired.
