QC Associate
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Job Location:
Monthly Salary:
Posted on:
30+ days ago
Vacancies:
1 Vacancy
Job Summary
Perform in-process and release testing of CAR-T products.
- Conduct assays including flow cytometry qPCR ELISA and microbiological
assays.
- Develop validate and transfer analytical methods for CAR-T product testing.
- Troubleshoot analytical methods and provide technical support during investigations.
- Analyze and interpret QC data prepare statistical reports and present results to teams.
- Author review and approve QC protocols procedures and documentation.
- Ensure regulatory compliance with GMP QC protocols across PoC centers.
- Manage lab supplies reagents and inventories effectively.
- Lead investigations of OOS/OOT results generate deviation reports and execute CAPA.
- Conduct assays including flow cytometry qPCR ELISA and microbiological
assays.
- Develop validate and transfer analytical methods for CAR-T product testing.
- Troubleshoot analytical methods and provide technical support during investigations.
- Analyze and interpret QC data prepare statistical reports and present results to teams.
- Author review and approve QC protocols procedures and documentation.
- Ensure regulatory compliance with GMP QC protocols across PoC centers.
- Manage lab supplies reagents and inventories effectively.
- Lead investigations of OOS/OOT results generate deviation reports and execute CAPA.
Requirements:
- Bachelors/Masters degree in Biotechnology Life Sciences or related field.
- Minimum 5 years of QC experience in biologics or cell therapy manufacturing.
- Bachelors/Masters degree in Biotechnology Life Sciences or related field.
- Minimum 5 years of QC experience in biologics or cell therapy manufacturing.
- Strong understanding of GMP and QC documentation practices.
- Willingness to travel extensively across India for the first two years.
- Excellent analytical organizational and communication skills.
- Willingness to travel extensively across India for the first two years.
- Excellent analytical organizational and communication skills.
Key Skills
- Computer
- IT Audit
- Catering
- Fire And Safety Engineering
- Front Office Management
