research associate.

job summary: Clinical Research Associate will support IVD (in vitro diagnostics test) clinical studies.   location: San Diego, California job type: Permanent salary: $70,000 - 75,000 per year work hours: 9 to 5 education: Bachelors   responsibilities: Conduct monitoring visits and activities in accordance with FDA Code of FederalRegulations, GCP guidelines, departmental SOPs, Work Instructions, and the ClinicalMonitoring PlanServe as primary site contact; establish and maintain regular communication with clinical sitesConduct Site-Qualification, Initiation, Interim and Closeout visits to include document review for accurate data recording, source data verification to protocol adherence and governing regulationsAssist with distribution, collection, and tracking of regulatory documents for site compliance and auditPrepare and maintain monitoring visit reports and site communication documentationIdentify and resolve routine site issues, protocol deviations, queries, study discrepancies and collects missing or incomplete informationAssist with sample tracking, supply shipments and other diagnostic requirementsUse of EDC and other electronic tools to review monitor listings and queriesReview of Investigator Site Files and Sponsor Study FilesAdditional project and tasks as determined by department and organizational needsTravel may be approximately 10%  qualifications: Bachelor's Degree2 years of related clinical trial monitoring experienceExperience of IVD clinical studies is preferred  skills: CRF, GCP (Good Clinical Practice), COV (Close-Out Visit), CTMS (Clinical Trial Management Systems), RMV (Routine Monitoring Visit), SIV (Site Initiation Visit) 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.EOEDisclaime 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.

job summary: Are you ready for a career and not just a job? Our client, one of the largest medical device companies in San Diego is looking for a Quality Associate 3- either day or second shift opportunity, in this role you will perform routine and non-routine analytical biochemical and molecular biology assays to support release, characterization and stability testing of raw materials, production intermediates and final goods. Interested? Please apply!   location: SAN DIEGO, California job type: Contract work hours: 7am to 3pm education: Bachelors   responsibilities: Responsibilities: Day to day management of a production process, management of a process flow that occurs across several departments. Perform routine and non-routine analytical biochemical and molecular biology assays to support release, characterization and stability testing of raw materials, production intermediates and final goods. Analysis of data generated by functional assays. Participate in developing and validating testing methodology, revising and updating Standard Operating Procedures Review data obtained for compliance to specifications and report abnormalities   qualifications: Experience level: ExperiencedMinimum 2 years of experienceEducation: Bachelors  skills: QualityLaboratory (2 years of experience is preferred) 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.

job summary: Seeking skilled and highly motivated candidates ranking from Scientist to Senior Research Associate to participate in cell line development through cellular reprogramming and genetic engineering in compliance with cGXP guidelines to further the development of novel cellular therapeutics for the treatment of cancer and immune disorders. The successful candidate will play a key role in the cGMP cell bank manufacturing team and in the advancement of the company's induced pluripotent stem cell (iPSC) platform. The candidate should have strong expertise in cell culture and aseptic techniques, with experience in cell line development and banking.   location: San Diego, California job type: Permanent salary: $85,000 - 105,000 per year work hours: 9 to 5 education: Bachelors   responsibilities: Participate in iPSC line and feeder cell line development by adhering to established cGMP SOPs and Batch Records covering, but not limited to: media preparation, cell culture and scale up, cellular reprogramming, genetic engineering and single cell sorting.Execute and document batch records and SOPs with high level of compliance to safety policies, quality system and cGMP guidance.Support and validate pilot study prior to iPSC MCB generation.Strong record keeping and maintenance of lab notebooks.Edit and review controlled documents as needed to ensure defined quality objectives are met.Present manufacturing activities and updates during departments meetings.   qualifications: BS / MS in Cellular Biology or similar discipline with a minimum of 3 years of experience in cell culture and aseptic techniquesStrong iPSC culture skills/experienceCRISPR engineering and cellular reprogramming experienceSelf-motivation with demonstrated ability to work both independently and in a team-oriented cross functional environmentExcellent communication, strong attention to detail with the ability to multi-task and prioritize multiple responsibilities simultaneously, time management/organizational skillsPositive outlook and a team-oriented attitude Preferred experience in any of the following: Experience in cGMP manufacturingKnowledge of cGMP regulations and FDA guidance applicable to biologics and cell therapy manufacturingCellular reprogramming and iPSC cultureFlow cytometryGenetic engineeringSingle cell cloning and high-throughput screeningExperience with automation and use in high throughput cell culture is a plus Working Conditions and Physical Requirements Will require working with cells and cell lines of human originWeekend and/or evening hours as necessary Benefits include: Medical, dental, vision, flex spending accounts, life insurance, disability, supplemental health, EAP, and travel assistance program This is a salaried position with a bonus target as well as RSU's.   skills: Cell Biology, Cell Cultures 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.EOEDisclaime 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.