Quality Control Technician
3 days ago
Must haves:
1. Experience in EM and/or WFI sampling
2. Experience working in a regulated environment
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
- Experience with Water and/or EM sampling
- Experience in aseptic conduct and technique
- Experience with sterile cleanroom gowning
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