26 Jul
QC Molecular Biology Analyst
Vacancy expired!
QC Cell and Molecular Biology Analyst Apex Systems is seeking a QC Cell and Molecular Bio Analyst to support routine testing and logistical activities. Working in a GMP environment, you will execute compendial test methods (pH, Volume, appearance, Osmolality) and core laboratory testing from ELISA, Cell Culture/counting, Flow cytometry, PCR, and other related testing. The Analyst will also support logistical activities in the lab including sample receipt and will support GMP QC laboratory maintenance by managing and/or monitoring facilities, and laboratory equipment and reagents.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 test methods data 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.
- Support minor equipment troubleshooting, laboratory maintenance, and cleaning activities.
- Manage 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.
- Accurately follow relevant SOPs, perform all activities in accordance with cGMP requirements reports abnormalities.
- Document test results to ensure completeness and accuracy per cGMP. Keep accurate documentation and tracks record.
- Support troubleshooting with minor assay performance issue and support the SOP related activities as requested
- Supports Discrepancy Management investigations and implementation of corrective and preventative actions as instructed
- Contributes toward the development and revision of SOPs and Test Methods.
- Support method validation and transfer of QC CMB methods and critical reagent qualification by executing as instructed.
- Support Change Control by gathering and providing information necessary to support simple changes to existing methods
- Perform non-routine laboratory tasks
- B.S. degree in a scientific discipline with at least 6 months of experiences in a cGMP compliant environment or equivalent combination of education and experience
- Demonstrated knowledge of laboratory techniques such as ELISA, Cell culture and Cell-based assay, PCR, Flow cytometry, etc.
- Must have previous working experience in aseptic technique.
- Must have extensive experience in qPCR assay. Additional experience in Flow Cytometry or Cell-based assay is plus.
- 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 skill. 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.
Vacancy expired!