Adverum Biotechnologies

QC Analyst II/III Reviewer (Contract)

Redwood City, CA · Mid

Sponsorship not specifiedDetected 55 days ago

RecruitingqPCRCRISPRMolecular BiologyResearchProtein AnalysisCommunicationOrganizational SkillsMicrosoft OfficeGxP

About the role

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.

Perform QC review of release, stability, and in-process testing documentation and data to ensure compliance with GxP requirements.
Review and follow SOPs, test methods, specifications, and controlled documents
support the revision and continuous improvement of QC procedures to maintain compliance.
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.
Review and follow SOPs, test methods, specifications, and controlled documents; support the revision and continuous improvement of QC procedures to maintain compliance.
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.

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.
Proficiency in MS Office and equipment-related software like Soft Max Pro is desired.

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
Experience with viral vector (adeno-associated virus) products is a plus.

Adverum is seeking a dedicated Quality Control Analyst to be a part of our vibrant team based in our Redwood City office.

This listing is sourced directly from Adverum Biotechnologies's careers page and normalized into a canonical job model.