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Quality Control Analyst

4 months ago

Newark, United States ACL Digital Full time

Job Title: QC Analyst/Analyst II, QC Cell and Molecular Biology.

Location: Newark, CA

Duration: 08 Months

This role is for an Analyst II, QC Cell and Molecular Biology.


Support method optimization, validation and method transfer, and critical reagent qualification by executing as instructed.

Perform 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 test methods data and supporting documentation.

Maintains GMP laboratories by monitoring lab equipment, pipettes, etc. and availability of lab supply.

Support minor equipment troubleshooting, laboratory maintenance, and cleaning activities.

Manage GMP and non-GMP samples, order and receive lab reagents and materials, and manage the inventories.

Accurately follow relevant SOPs, performs all activities in accordance with cGMP requirements reports abnormalities.

Document test results to ensure completeness and accuracy per cGMP. Keeps accurate documentation and tracks record.

Support troubleshooting with minor assay performance issues.

Support discrepancy management investigations and implementation of corrective and preventative actions as instructed.

Contribute toward the development and revision of SOPs and Test Methods.

Support Change Control by gathering and providing information necessary to support simple changes to existing methods.

Perform non-routine laboratory tasks.

Other duties as assigned.

Skills:

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 perform QC laboratory maintenance related duties as assigned

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.

Able to seek and accept input from more senior team members for the performance of assignments as needed.

Able to multi-task and adapt to changing business requirements in a dynamic corporate environment.

Good communication skills. Able to maintain good interaction with peers and leadership within Quality Control

Physically able to lift LN2 freezer rack or move up to 20L buffer if needed as laboratory activities.

Education:

B.S. degree in a scientific discipline with 3+ years of experiences in a cGMP compliant environment or equivalent combination of education and experience