job summary: The QC Analytical Lab Specialist / Sr. Specialist has a unique opportunity to play a key role in building of the QC laboratory from ground up for a Cell and Gene therapy biotech startup. The QC Analytical Lab Specialist will be responsible for leading and managing activities for method transfer, qualification, and validation of client methods. The role is responsible for execution of testing for cGMP samples for in-process, lot release and stability samples in-house. The role will support and coordinate the biochemical, cell based, molecular biology and general chemical testing of raw material, in-process, final product, and stability samples submitted to external laboratories. This role will be responsible for documentation that is compliant with all applicable procedures, standards, and cGMP regulations. location: Arcadia, California job type: Temporary salary: $33 - 39 per hour work hours: 9 to 5 education: Bachelors responsibilities: Leads implementation of new methods transferred by the clients and Analytical Development lab.Originates and revises QC related procedures and analytical methods.Leads and supports invalid assay, exceptions, and lab investigations.Ensures compliance to all quality requirements to meet audit standards and regulatory compliance.Maintains lab equipment, reagents inventory, and documentation to ensure accurate, timely, and costeffective analysis of materials and products.Assists in creating training materials and trains staff on methods and related SOPsCollaborates with other Functional Areas (Analytical Development, Materials Sciences and Technology, Process Development and Manufacturing) for methods transfer, qualifications, validation, sample plan development and timely testing of samples.Executes assays to assess various cell and gene therapy products using flow cytometer, PCR, and cell-based assays.Performs and troubleshoots on laboratory methods and procedures including ddPCR, qPCR, ELISA, and flow cytometry. - Implements, and qualifies current and new pharmacopoeia methods to ensure compliance with cGMP's and other regulatory requirements.Analyzes and summarizes data into reports and certificate of analysis with attention to details.Participates in risk assessment, HAZOP and FMEA.Reviews and proposes corrective and preventive actions and improvements identified through investigations and audits.Performs sample management tasks, including labeling, shipping to external labs, inventory, and disposal of samples.Collaborates with external clients, contractors, and vendors.Participates with internal audits and external audits and assists in authoring responses and implementation of actions.Other duties as assigned by management. qualifications: Bachelor's degree (BS) in Biochemistry, Chemistry, Molecular and Cell biology, or Biology required. Masters degree preferred. In lieu of this requirement, work experience may be considered3-5 years' flow cytometry experience in the Pharmaceutical, Life Sciences industry with cGMP, GLPExperience with problem solving methods such as DMAIC or other similar Root Cause Analysis ToolsStrong knowledge of cGMP and ICH guidelines. Other regulatory agencies experiences preferredBasic knowledge of Compendial (i.e., USP, EP, JP, etc.) requirements and standardsExperience with electronic Laboratory Inventory Management Systems (LIMS) skills: Cell Biology, Flow Cytometry, GMP (Good Manufacturing Practice) Equal Opportunity Employer: Race, Color, Religion, Sex, Sexual Orientation, Gender Identity, National Origin, Age, Genetic Information, Disability, Protected Veteran Status, or any other legally protected group status.Qualified applicants in San Francisco with criminal histories will be considered for employment in accordance with the San Francisco Fair Chance Ordinance. We will consider for employment all qualified Applicants, including those with criminal histories, in a manner consistent with the requirements of applicable state and local laws, including the City of Los Angeles' Fair Chance Initiative for Hiring Ordinance. For certain assignments, Covid-19 vaccination and/or testing may be required by Randstad's client or applicable federal mandate, subject to approved medical or religious accommodations. Carefully review the job posting for details on vaccine/testing requirements or ask your Randstad representative for more information.