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job summary: The QC Microbiology Lab Specialist will assist in the method transfer and validation studies, support commissioning new equipment, support revising and editing Quality system procedures, assist continuous improvement initiatives, and support QC on project teams for clinical and commercial products. Working with QA, manufacturing, and analytical development groups, the QC Microbiology Specialist will be responsible for meeting QC timelines related to deliverables such as method transfer reports, test methods, change controls, and validation protocols and reports.   location: Arcadia, California job type: Temporary salary: $36 - 42 per hour work hours: 9 to 5 education: Bachelors   responsibilities: Assist the transfer and validation of test methods in support of drug substance release and stability testing.Revise test methods, validation protocols and reports, Quality system SOPs, and other supporting documents.Support equipment onboarding and validation lifecycle, including operation and maintenance procedures and software systems.Assist initiating change controls, support investigations, CAPAs, and continuous improvement initiatives to successful completion.Represent QC Microbiology on project teams for clinical and commercial products with primary responsibility for validation of Drug Substance release assays.Support performing validation of microbiological assays and assist provide training related to in-process and drug substance testing, equipment, environmental and utility monitoring to include Bioburden, Endotoxin, Growth Promotion testing, etc.Assist and support to perform environmental and utility monitoring of the cell and gene therapy production facility according to written procedures while fully gowned including operational monitoring and personnel monitoring during aseptic processing, and aseptic filling. Assist and support to perform routine environmental monitoring, as needed to meet schedules.Read environmental and utility monitoring plates by counting microbial colonies. Fill out appropriate reports and forms contemporaneously. Assist to perform microbial identification like gram stains, gene sequencing. Track all data and complete in a timely manner. Perform all activities in compliance with cGMP regulations.Assist preparation and presentation of quarterly and annual reports, trend investigations, statements of quality, and other applicable reports to management.Support onboarding and qualification of laboratory equipment and GMP software systems.Generate and write SOPs and protocols related to test methods involving product lot release.Draft technical documents including test methods, validation documents, and deviations.Assist implementation of change controls, support investigations, and complete CAPAs in support of GMP operations.Assist in purchasing all necessary supplies, needed for QC Microbiology. Assist to receive supplies, log-in and store appropriately following written procedures. Assist to perform growth promotion analyses on all microbiological media lots received. Report results on appropriate forms.Inspect and clean the laboratory and its equipment on a regular basis. Perform laboratory and equipment cleaning, preventative maintenance and calibration as described in written procedures. Follow written procedures for cleaning. Record all necessary information and maintain current, accurate, legible records of all work performed. Report problems to management in a timely manner and support finding creative solutions to resolve them.Ensure compliance to all quality requirements to meet audit standards and regulatory compliance.Maintain lab equipment, reagents inventory, and documentation to ensure accurate, timely, and cost-effective analysis of materials and products.Assist creating training materials and training staff on methods and related SOPs.Support implementation and qualification of current and new pharmacopoeia methods to ensure compliance with cGMP's and other regulatory requirements.Assist analyzing and summarizing data into reports and certificates of analysis with attention to details.Participate in risk assessments such as HAZOP's and FMEA's.Assist proposing corrective and preventive actions and improvements identified through investigations and audits and assist performing effectiveness checks of CAPA's.Perform sample management tasks, including labeling, shipping to external labs, inventory, and disposal of samples.Participate in collaboration meetings with external clients, contractors, and vendors.Participate in internal audits and external audits and support providing responses and implementation of actions related to observations.Other duties as assigned by management.  qualifications: Bachelor's degree in Microbiology, Molecular and Cell biology, Biology or related field required. In lieu of this requirement, work experience may be consideredMinimum of 5 years of work experience in the Pharmaceutical, Life Sciences industry with cGMP, GLPA strong background in method development, qualification and validation is highly desired. A background in quality control testing related to Biopharmaceuticals is required.Experience 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 Information Management Systems (LIMS)Strong understanding of Microbiology related to drug substance or drug product manufacturing.Experience with relevant microbiology laboratory equipment and software  skills: Cell Biology, CAPA, Biology, GLP (Good Laboratory Practice), ICH Regulations, 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.

It's time to get on the road! We're searching for Patient Care Techs (PCT) to fill immediate openings in the city of Los Angeles, CA. If this sounds great to you, and you have 2+ years of experience, keep reading and we'll make sure you get all the details. What will I do? Patient Care Techs (PCT) will provide the direct, patient care for assigned patients under the direct supervision of a licensed nurse. They are responsible for accurate documentation of information related to the patient treatment. They assist licensed nurse with pre and post dialysis patient assessments and their documentation. PCTs monitor and document dialysis treatment parameters on Dialysis Flow Sheets. They report any significant information or change in patient condition to the supervisor and assist with all emergency operational procedures. They initiate basic CPR measures in the event of cardiac and/or pulmonary arrest and respond to emergency situations related to dialysis treatment. What are the benefits? Weekly take-home pay between $20 and $60 per hour including per- diems-top-tier benefits that help your focus on taking care of your patients and know you're being taken care of, too. What else do I need to know? A qualified Patient Care Tech (PCT) will have an high school degree or G.E.D, and education in physical science and/or training in laboratory techniques, as well as previous patient care experience in a hospital setting or related facility, have successfully completed a training course in the theory and practice of hemodialysis, and hold an active CPR certification and other unit specific certifications. Randstad Healthcare is your career concierge-savvy, smart and right by your side when you're considering a new position, city or job title. Let us help you make your next move: Get in touch with one of our Career Agents today!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.

Our client is hiring for a Surgical Technologist position located near Downey, CA. The position is a contract to start, but candidates interested in permanent positions after the contract ends are highly preferred. Below are further details about the position. If you are interested, or may know of someone interested, please apply! Job Description the Surgical Technologist II:-Performs as first scrub during procedures, which reflects advanced knowledge of anatomy and aseptic and surgical technique.-Expedites the operative procedure by anticipating the needs of the surgeon. Keeps the circulating nurse informed of upcoming patient care needs.-Establishes and maintains an organized sterile field and applies principles of asepsis. Qualifications CST - 2 years experience Pay range: $27.00-34.00/hour based on experience 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.