Microbiology Laboratory Technician

1 month ago


Fremont, United States Integrated Resources, Inc ( IRI ) Full time

MUST HAVES:

Experience in EM and/or WFI sampling

Experience working in a regulated environment

Experience in GxP data reporting and documentations.


Summary:

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, and 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
  • Excellent organizational and multi-tasking skills, attention to detail, and the ability to adapt to changing priorities.
  • Ability to handle conflicts.
  • Solutions oriented and good at making decisions under time pressure
  • Excellent organizational and communication skills required.


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