QC Analyst II – GMP Analytical Lab, Biotech

Allogene Therapeutics; Newark (CA); On-site; USD 65,000 - 90,000; Full time

Benefits offered by this job

Annual performance bonus

Equity

Health insurance

Generous PTO

Job summary

Allogene Therapeutics in Newark, CA is seeking an Analyst II to support routine testing in a GMP QC laboratory. You will execute compendial methods (pH, volume, appearance, osmolality) and core tests (ELISA, cell culture, flow cytometry, PCR/dPCR). Onsite five days a week at the manufacturing facility in Newark, CA.

The role involves ensuring product release quality, documentation, equipment maintenance, and collaboration with QA/QC teams. Requires a B.S.

Qualifications

• A minimum B.S. degree in a scientific discipline with minimum 3 years of experiences in a cGMP compliant environment or equivalent.
• Demonstrated knowledge of laboratory techniques such as Flow cytometry, ELISA, Cell culture and Cell-based assay, PCR etc.
• Must have previous working experience in aseptic technique.
• Experience in maintenance of GMP laboratory, laboratory equipment, and the status of pipettes and supplies.
• Able to follow instructions and SOPs precisely and able to make/keep accurate and contemporaneous documentation.
• Experience of supporting analytical method validation and transfer and reagent qualification.
• Experience of supporting troubleshooting and optimization of the method to improve the performance.
• Experience of supporting Invalid, OOE, and OOS investigation and CAPA initiation.
• Able to solve minor problems and troubleshoot, as necessary.
• Good organizational and planning skills, and an ability to work efficiently.
• Able to learn new skills rapidly and achieve proficiency as necessary.
• Able to seek and accept input from more senior team members for the performance of assignments as needed.

Responsibilities

• Performs QC analytical testing to support the release and stability of final products to support the release of products for commercial use, with consideration of compliance, quality, and consistency
• Review data package and supporting documentation.
• Maintains GMP laboratories by monitoring lab equipment, pipettes, etc. and availability of lab supply. Perform instrument calibration and equipment cleaning as needed.
• Accurately follows relevant SOPs, performs all activities in accordance with cGMP requirements reports abnormalities.
• Documents test results to ensure completeness and accuracy per cGMP. Keeps accurate documentation and tracks record.
• Support minor equipment troubleshooting, laboratory maintenance, and cleaning activities.
• Manages GMP and non-GMP samples, order and receive lab reagents and materials, and manages the inventories.
• Support ordering and qualification of critical reagents as requested.
• Support troubleshooting with minor assay performance issues and support the SOP related activities as requested.
• Support investigations and implementation of corrective and preventative actions as instructed.
• Support method validation and transfer of QC methods by executing as instructed.
• Support Change Control by gathering and providing information necessary to support changes to existing methods.
• Contributes toward the development and revision of SOPs and Test Methods.
• Perform non-routine laboratory tasks.
• Other duties as assigned.

Skills

Flow cytometry

ELISA

Cell culture

PCR/dPCR

Aseptic technique

Documentation

cGMP

Laboratory maintenance

Education

B.S. in a scientific discipline

Tools

Pipettes

ELISA reader

Flow cytometer

PCR machines

Job description

Allogene Therapeutics in Newark, CA is seeking an Analyst II to support routine testing in a GMP QC laboratory. You will execute compendial methods (pH, volume, appearance, osmolality) and core tests (ELISA, cell culture, flow cytometry, PCR/dPCR). Onsite five days a week at the manufacturing facility in Newark, CA.

The role involves ensuring product release quality, documentation, equipment maintenance, and collaboration with QA/QC teams. Requires a B.S.