Quality Control Technician

3 days ago


Fremont, United States Integration International Inc. Full time

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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