Quality Assurance Assistant

3 weeks ago

Lake Forest, United States CellCarta Full time
Job DescriptionJob DescriptionQuality Assurance Assistant

Are you looking to make your next career move? CellCarta, a Contract Research Organization, is hiring a Quality Assurance Assistant to join our dynamic team. As a QA Assistant, you will have the opportunity to use your expertise and skills to ensure that our services meet the highest industry standards. Come work with a team of talented individuals who are committed to making a positive impact on human health and well-being. Apply today and take the first step towards an exciting new career with CellCarta

Summary
The Quality Assurance (QA) Assistant is responsible for assisting quality assurance associates, auditors, and management with quality control and quality assurance tasks within a laboratory providing services to pharmaceutical and biotech companies. The QA Assistant ensures that the company operates according to its quality system to provide services that meet customer requirements and maintains compliance with regulatory agencies in accordance with applicable state and federal laws.

Responsibilities

  • Responsible for assisting with auditing and monitoring laboratory studies to ensure compliance with relevant portions of GLP, GCP, GCLP, and other states, federal and international laws.
  • Perform inspections of study records at defined intervals to assure the integrity of testing.
  • Perform inspections of QC-reviewed transcribed data to ensure data was transcribed accurately and in compliance with Mosaic Laboratories’ standard procedures and with study protocols.
  • Submit audit reports to management indicating areas of deficiency within the laboratory that require corrective action.
  • Assist with coordinating the review, implementation, filing and electronic organization of Standard Operating Procedures (SOPs), if needed.
  • Review laboratory reports to ensure the completeness and accuracy of data and sign the QA statement or the cover page of reports that have been reviewed.
  • Participate in FDA, CLIA, state, and CAP inspections, if requested. Represent Mosaic with the highest level of professionalism during inspections.
  • Provide prompt and professional communication with staff regarding QA issues including participating in laboratory meetings.
  • Assist with QA review components of biannual monitors.
  • Responsible for other duties as assigned by the supervisor.

Requirements

  • Bachelor’s degree in Biology or a related science field preferred.
  • Previous experience in a laboratory with compliance with CAP, CLIA and state laboratory regulations is preferred.
  • Strong written and verbal communication skills.
  • Extensive experience with Microsoft Excel and other Office programs.

Working Conditions

  • 40 hours per week, 100% onsite.

What we can offer

CellCarta is made up of dedicated professionals who are focused on achieving our mission of impacting the future of patient therapy. We make a difference in the lives of patients around the world

We offer a wide range of benefits including:

  • Competitive wages
  • Medical, dental, and vision benefits
  • 401k retirement savings plan with a healthy match
  • Vacation and sick time
  • Employee Assistance Program
  • Career development opportunities
  • Continuing education

About Us

CellCarta is a rapidly growing, stable company. We are a leading provider of pre-clinical and clinical trial services to pharmaceutical and biotechnology companies. Our laboratory service offerings include immunohistochemistry, FISH, CTC isolation and characterization, chemosensitivity testing, tissue procurement, flow cytometry, ELISA, mutation testing, cell expansion, and colony-forming assays. CellCarta is a CLIA-licensed and CAP-accredited laboratory, and we perform studies in compliance with the relevant portions of Good Laboratory and Good Clinical Practices.

Join us as we make an impact on the future of patient therapy

Supplemental Information

Candidates must be legally authorized to work in the United States on a permanent basis. Verification of employment eligibility will be required at the time of hire. Visa sponsorship is not available.

The information collected to review your application will be processed by the human resources services of CellCarta Biosciences Inc. and its affiliates (collectively, “CellCarta”). The legal basis for this processing is the legitimate interest of CellCarta to evaluate the suitability of candidates for the roles available at CellCarta.

CellCarta will only process that information which is necessary to evaluate your application. This information includes identifying information such as your name, address, email address and phone number, as well as information about your education and professional experience, including previous positions and your CV. Such information is required for us to complete your applicant file, assess your suitability for the role and comply with applicable laws. CellCarta may obtain personal information from other sources, such as during reference, background, or employment checks, with your permission, and from third party sources such as recruitment and assessment sites or professional social media sites, in each case only if such information is relevant to reviewing your application. Your personal information will be retained only for so long as reasonably necessary and in accordance with applicable laws. This information will be processed confidentially and only accessed by those who have a need for the recruitment process. Please note that the information comprising your applicant file may be processed in a country that is not where you are located (for example, you might be in the European Economic Area or Québec, Canada, whereas your applicant file may be reviewed by CellCarta in the United States). If you are offered and accept employment with CellCarta Biosciences Inc. or one of its affiliates, the information collected will become part of your employment record. If you do not want us to retain your information, or want us to update it, please contact privacy@cellcarta.com.


 

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