Quality Control Manager – Contract Testing Lab
Adverum Biotechnologies
contract
Posted on:
Location Type: Hybrid
Location: Redwood City • California • United States
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Salary
💰 $55 - $65 per hour
About the role
- Manage all QC Release and Stability sample testing activities at all CTLs, including but not limited to, sample and reagent shipment coordination, shipment temptale review, updated test method review/approval, advise on lab scheduling and test priority, support problem solving activities at CTLs for test directives, support OOS/OOE/OOT/Atypical lab investigations, final test data COA review/acceptance.
- Manager/support method transfer and method validation activities at CTLs and CMOs, including but not limited to, protocol review/approval, reagent shipment coordination, method validation design and document review/approval, validation data packet evaluation, final report review/approval.
- Author and revise internal SOPs, forms, and documentation related to CTL management, data review, and lab investigation activities.
- Support CTL and CMO lab audit activities if needed.
- Participate in internal audits, external inspections, and quality system assessments by providing documentation and subject‑matter expertise.
- Collaborate cross‑functionally with QC, QA, Manufacturing, Supply Chain, and Facilities to improve processes, reduce risks, and strengthen compliance.
- Contribute to continuous improvement initiatives to streamline laboratory workflows and enhance data integrity.
Requirements
- Bachelor’s degree in a scientific discipline (Biology, Chemistry, Biochemistry, or related field).
- Minimum 4–6 years of work experience in a GMP analytical laboratory and/or QC environment.
- Prior CTL management experience is preferred
- Strong understanding of cGMP requirements and regulatory expectations for biotechnology and pharmaceutical QC operations.
- Experience with LIMS, electronic inventory systems, or sample tracking databases.
- Familiarity with stability programs and chain‑of‑custody workflows.
- Strong organizational skills with exceptional attention to detail and documentation accuracy.
- Excellent communication skills and ability to work cross‑functionally.
- Demonstrated problem‑solving ability and adaptability to shifting priorities.
- Proficiency with MS Office and laboratory equipment software.
Applicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard Skills & Tools
method validationQC testingdata reviewSOP authoringprotocol reviewlaboratory workflowssample trackingOOS investigationCOA reviewGMP compliance
Soft Skills
organizational skillsattention to detailcommunication skillsproblem-solvingadaptabilitycollaborationcross-functional teamworkdocumentation accuracycontinuous improvementrisk reduction