QC Analyst II/III Reviewer (Contract)

Adverum Biotechnologies•Redwood City, CA

10d•Onsite

About The Position

Adverum Biotechnologies, Inc., a subsidiary of Eli Lilly and Company, is a clinical-stage company focused on developing gene therapy for prevalent ocular diseases. They are seeking a Quality Control Analyst to join their team in Redwood City. This role involves performing QC review of various assay techniques, systems, policies, processes, procedures, and controls related to the analytical examination of clinical materials. The analyst will report to the Quality Control Manager, Quality Control Lead, or as part of a project hierarchy and will collaborate with the QC team and other cross-functional teams.

Requirements

Bachelor’s degree in biology, chemistry, Biochemistry, or a related field.
Minimum of 3-5 years of experience (QC II) or 3-5 years’ experience (QC III), preferable in a bio-pharma analytical laboratory setting.
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.
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.
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.
Must possess knowledge of cGMPs and regulatory prerequisites concerning the biotechnology and pharmaceutical sectors.
Familiarity with statistical methods applicable to the analysis of experimental data.
Proficiency in general and non-routine laboratory skills.
Exceptional interpersonal, communication, and organizational skills are a must.

Nice To Haves

A solid foundation in molecular biology is desired.
Experience with viral vector (adeno-associated virus) products is a plus.
Proficiency in MS Office and equipment-related software like Soft Max Pro is desired.

Responsibilities

Perform QC review of release, stability, and in-process testing documentation and data to ensure compliance with GxP requirements.
Review, analyze, and verify analytical data for drug substance and finished product testing, ensuring accuracy, completeness, reliability, and data integrity.
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.
Review and follow SOPs, test methods, specifications, and controlled documents; support the revision and continuous improvement of QC procedures to maintain compliance.
Review completed testing records, sample documentation, and final result packages for release, stability, and in-process studies prior to approval.
Identify, document, and own deviations through closure, including support for investigations, impact assessments, root cause analysis, and corrective actions as needed.
Support qualification and validation activities through protocol and report review, documentation assessment, and verification of compliance with approved requirements.
Support QC investigations, assay lifecycle activities, and nonclinical sample review as needed, collaborating cross-functionally to resolve quality and compliance issues.
Provide guidance to junior staff, apply sound quality judgment in daily review activities, and communicate effectively with internal teams and external testing laboratories.