Senior QC Analyst, Quality Control Analytical

United States·AlamedaFull-timesenior

OtherQuality Control

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Quick Summary

Overview

Genefab is seeking an experienced analyst to join it’s Quality Control Analytical group. In this role, you will support the GMP QC testing at GeneFab, with a focus on testing, method transfer, qualification, troubleshooting and investigations. Provide technical expertise (SME).

Technical Tools

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Provide technical expertise (SME).

Provide technical support to Analytical Development and QC Analytical Operations as needed.

Develop, implement, and update all Quality Control SOPs, testing records and other documentation needed for cGMP compliance.

Perform QC testing on in-process and final product samples to support release and stability testing.

Lead and perform technical root-cause investigations for aberrant results and deviations relating to analytical methods.

Lead and train junior employees to ensure testing procedures and practices comply with all applicable regulations and procedures.

Plan, lead, and execute analytical method transfers, qualifications, and validations.

Draft, Review, and Approve Method Transfer Protocols and Reports

Generate and review procedures, protocols and reports.

Proactively identify areas for continuous improvement in processes and procedures and lead these initiatives.

Collaborate closely with Interdepartmental MSAT, ASAT, and Manufacturing groups to support, execute, and/or provide oversight in the execution of method optimization, characterization, troubleshooting, transfer, and qualification

Perform additional duties as assigned

B.S. degree in biology or related field with experience in cell therapy, immunology, cancer biology, or a closely related field.

Minimum of 5+ years of GMP/QC Laboratory experience.

Demonstrated ability to collaborate and work in cross-functional teams.

Strong organizational skills and attention to detail

Strong time management skills with a proven ability to meet deadlines

Strong analytical and problem-solving skills

Experience with relevant technologies such as: multicolor flow cytometry, cell culture (e.g., aseptic techniques, cell line expansion), multiplexed immunoassay, qPCR, and dPCR methods, Luminex, and ELISA.

Experience in GMP.

Experience with contract laboratories and or CDMO is a plus

Knowledge related to laboratory information management systems (LIMS) and electronic lab notebook record keeping (ELN) is a plus

Proficient in MS Word, Excel, Project, and PowerPoint

Experience with cell therapy or gene therapy is a plus

Availability to work extended hours such as evenings or weekends to meet deadlines when necessary

Comfortable in a fast-paced environment with minimal direction and able to adjust workload based on changing priorities

Self-motivated, detail-oriented, and willing to accept temporary responsibilities outside of the initial job description

Able to lift up to 40 pounds