3. Experience in GxP data reporting and documentations.
Purpose:
The Associate/ Technician - Quality Control will perform day-to-day QC activities while ensuring accuracy, timeliness and in compliance with current cGMP and regulatory expectations of cell-based products. The day-to-day activities will include but not limited to sample collection/ preparation, data entry and reporting, procuring and maintaining lab supplies.
Essential Functions: • Perform routine Environmental monitoring, personnel monitoring sampling, and WFI sampling • Perform data entry into electronic system and compile data package for approval • Revise documentation such as SOPs, training materials, and other required documentation • Coordinate for sample pick-up/ shipments • Order, stock, and inventory supplies for the QC laboratory • Support additional projects and assignments assigned by lead and reporting manager • Performs all job duties and responsibilities in a compliant and ethical manner and in accordance with all applicable healthcare laws, regulations and industry codes • Support additional projects assigned by reporting manager
Qualifications: • Bachelor's Degree required, within Microbiology/Biology/Chemistry/Life Sciences or related field preferred. • Prior industry experience preferred. Preferred within the Pharmaceutical/Biotech industry. Relevant experience is defined below.
Experience with the application of cGMPs, USP/NF, EuPH., FDA guidelines and ICH guidelines with the pharmaceutical industry
Experience writing standard operating procedures and other cGMP documentation