Senior Quality Control Specialist

GeneFab; Alameda (CA); On-site; USD 90,000 - 140,000; Full time

Job summary

GeneFab in Alameda, CA is seeking a Senior Quality Control (QC) Specialist to perform GMP analytical testing in a CDMO setting for Cell Therapy and Gene Therapy products. The role includes method transfers, SOP development, and support for regulatory and client needs.

You will work cross-functionally with QC, QA, Manufacturing, and AD teams to support clinical and commercial tech transfer activities, while mentoring junior analysts in a fast-paced environment.

Qualifications

• 5+ years of GMP QC laboratory and Method Transfer experience in Cell Therapy/ Gene Therapy.
• Hands-on experience with cell therapy analytical methods (cell culture, flow cytometry, ELISA, dPCR, qPCR, cell-based assays).
• Strong understanding of GMP, ICH, USP, and regulatory requirements for biologics/cell therapies.
• CDMO/contract lab experience is a plus.
• Excellent organizational, communication, and leadership skills.
• Experience supporting clinical and commercial manufacturing.
• Proficiency in ELN, LIMS, and Veeva electronic systems.
• Comfortable in a fast-paced biotech environment with shifting priorities.
• Ability to foster accountability, quality, and continuous improvement.
• May support and/or perform analyst tasks on non-routine basis.

Responsibilities

• Provide technical expertise (SME).
• Support Saturday and Sunday GMP manufacturing operations.
• Plan, lead, and execute analytical method transfers, qualifications, and validations.
• Develop, implement, and update QC SOPs, test records and documentation for cGMP.
• Provide technical support to Analytical Development and QC Analytical Operations.
• Perform GMP analytical testing for in-process, release, characterization, and stability samples.
• Participate in laboratory investigations including OOS, OOT, deviations, errors, and CAPAs.
• Participate in Risk Assessments and Continuous Improvement initiatives.
• Draft, review, and approve Method Transfer Protocols and Method Transfer Reports.
• Generate and review procedures, protocols and reports.
• Lead continuous improvement initiatives in processes and procedures.
• Maintain laboratory readiness for inspections.
• Perform data review ensuring accuracy and ALCOA+ data integrity.
• Perform additional duties as assigned.

Skills

GMP knowledge

Analytical method transfer

Laboratory documentation

ALCOA+ data integrity

Education

Bachelor’s degree in biology, chemistry, biochemistry, or related scientific discipline

Advanced degree (MS/PhD) in a related field

Tools

ELN

LIMS

Veeva

Job description

About the role

The Senior Quality Control (QC) Specialist is responsible for performing GMP analytical testing to support the manufacture and release of Cell Therapy and Gene Therapy products in a contract development and manufacturing organization (CDMO). This role performs complex laboratory testing, ensures compliance with GMP requirements, assists with method qualification and transfer activities, investigates laboratory events, and mentor’s junior analysts.

The successful candidate will possess strong technical expertise in cellular and molecular analytical methods, maintain high-quality laboratory documentation, and support a fast-paced, client-focused manufacturing environment.

The individual will work cross-functionally with QC, QA, Manufacturing, and AD teams to support clinical and commercial tech transfer activities.

What you’ll do

• Provide technical expertise (SME).
• Support Saturday and Sunday GMP manufacturing operations.
• Plan, lead, and execute analytical method transfers, qualifications, and validations.
• Develop, implement, and update all Quality Control SOPs, test records and other documentation needed for cGMP compliance.
• Provide technical support to Analytical Development and QC Analytical Operations as needed.
• Perform GMP analytical testing for in-process, release, characterization, and stability samples.
• Participate in laboratory investigations including OOS, OOT, deviations, laboratory errors, and CAPAs.
• Participate in Risk Assessments and Continuous Improvement initiatives.
• Draft, Review, and Approve Method Transfer Protocols and Method Transfer Reports.
• Generate and review procedures, protocols and reports.
• Proactively identify areas for continuous improvement in processes and procedures and lead these initiatives.
• Maintain laboratory readiness for internal, client, and regulatory inspections.
• Perform data review to ensure accuracy, completeness, and ALCOA+ data integrity principles.
• Perform additional duties as assigned.

Knowledge and Skills

• Strong understanding of cGMP regulations (21 CFR Parts 210, 211, and 1271).
• Knowledge of USP requirements applicable to biologics and cell therapy.
• Familiarity with ICH guidance and ALCOA+ principles.
• Excellent laboratory documentation practices.
• Strong analytical and troubleshooting skills.
• Ability to manage multiple priorities in a fast-paced CDMO environment.
• Strong written and verbal communication skills.
• Ability to work independently with minimal supervision.
• Demonstrated attention to detail and commitment to quality.

Qualifications

• Bachelor’s degree inbiology,chemistry,biochemistry, or related scientific discipline; advanced degree is a plus.
• Minimum of 5+ years of GMP Quality Control laboratory and Method Transfer experience in Cell Therapy, Gene Therapy,
• Hands-on experience with cell therapy-related analytical methods such as cell culture, flow cytometry, ELISA, dPCR, qPCR, and cell-based assays.
• Strong understanding of GMP, ICH, USP, and regulatory requirements applicable to biologics/cell therapies.
• Experience with contract laboratories and or CDMO is a plus
• Excellent organizational, communication, and leadership skills.
• Experience supporting clinical and commercial manufacturing.
• Proficiencyin electronic systems such as ELN, LIMSand Veeva.
• Comfortable in a fast-paced, dynamic biotech environment with shifting priorities.
• Demonstrated ability to foster a culture of accountability, quality, and continuous improvement.
• May need to support and/or execute analyst tasks on a non-routine basis.