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Quality Assurance Assistant
CellCartaNaperville, United Statesfull_timeVerifiedPosted 6 Sept 2024
About the role
Quality 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
We offer a wide range of benefits including:
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
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
- Bachelor of Science degree (Biotechnology, Biology, Pharmaceutical, etc)
- 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.
- 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.
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.
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
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