Quality Assurance Assistant

3 days ago

Naperville, 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
Reporting to the Associate Director, Quality Assurance, the Quality Assurance Assistant is responsible for supporting the day-to-day Quality Assurance activities related to assessing and reporting on the compliance of studies and facilities with the applicable standard operating procedures (SOPs), plans and protocols, policies, standards, and regulations.

Responsibilities
  • Performs internal study-, process-, and facility-based audits in a team setting.
  • Maintains QA trackers and other documentation.
  • Maintains QA records including routine filing and archives
  • Provides prompt and professional communication with staff regarding QA issues including participating in laboratory meetings.
  • Contributes to the review and writing of SOPs, if requested.
  • Assists in the hosting of sponsor and regulatory body audits / inspections.
  • Document Management.
  • Electronic Quality Management System activities.
  • Assists with regulatory audits, CAP, and BSI inspections
  • Assists with coordinating the review, implementation, filing and electronic organization of Standard Operating Procedures (SOPs), if needed.
  • Responsible for other duties as assigned by the supervisor
     
Education
  • Bachelor of Science degree (Biotechnology, Biology, Pharmaceutical, etc)
     
Main Requirements
  • 1-2 years QC/QA experience with regulated pharmaceutical studies.
  • Knowledge of GLP (OECD Principles of Good Laboratory Practice, US FDA 21 CFR Part 58), GCP (ICH Guideline for Good Clinical Practice), GCLP (EMA, WHO Good Clinical Laboratory Practice), ISO13485, and/or related laws, regulations, standards, and guidance documents.
  • Strong attention to detail and excellent investigative skills.
  • Organized and self-motivated, able to adapt to rapidly changing priorities in a team environment.
  • Identify and / or resolve quality issues in a proactive, diplomatic, flexible, and constructive manner.
  • Clear, concise written and spoken English.
     
Working Conditions
  • Monday – Friday, 8am – 4:30pm.
  • Hybrid flexibility to WFH 1-2 days/week.
  • Must accept to perform activities in a Biosafety Level (BSL) 1 or 2 laboratory where biological samples may be either naturally or experimentally infected with potentially hazardous viruses.
     
Benefits
We offer a wide range of benefits including:
  • Competitive wages;
  • Medical, dental, and vision benefits;
  • 401k retirement savings plan with a healthy match;
  • Employee Annual Incentive Plan (EAIP);
  • Employee Assistance Program (EAP);
  • Vacation and sick time;
  • Referral program;
  • Career development opportunities.
     
About CellCarta
CellCarta is a leading provider of specialized precision medicine laboratory services to the biopharmaceutical industry. Leveraging its integrated analytical platforms in immunology, histopathology, proteomics, and genomics, as well as related specimen collection and logistics services, CellCarta supports the entire drug development cycle, from discovery to late-stage clinical trials. The Company operates globally with facilities located in Canada, USA, Belgium, Australia, and China.
Joining CellCarta means working with 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 
Join us as we make an impact on patient therapy

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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