JOIN OUR TEAM
Quality Control Technician
JOB OVERVIEW:
The Quality Control Technician (QC Technician) is a vital position in the operations of Celltex’s laboratory services. The primary responsibility of the QC Technician is to test and inspect the environment, materials, and samples to ensure the quality of banked and outgoing products.
JOB DUTIES:
- Follows Celltex’s Quality Control SOPs, policies and procedures
- Maintain compliance to cGMP/GLP guidelines and apply them at all times
- Maintain aseptic techniques while performing on all activities
- Log, document, and verify the receipt of incoming specimens
- Review documents and write Certificate of Analysis for final product
- Assist trending Environmental Monitoring Data
- Perform sterility testing of outgoing products, incoming specimens, reagents, cell cultures, and media to ensure the absence of microbial growth
- Record, review and verify documents and forms of all samples related to QC activities
- Perform endotoxin testing of final products to ensure current levels are within the established acceptance criteria
- Perform mycoplasma testing of outgoing products, incoming specimens, cell cultures, and media to ensure current levels are within the established acceptance criteria
- Determine cell counts and cell viability for outgoing products
- Perform environmental sampling and testing to determine the sterility and cleanliness of work areas
- Perform subcultures of samples as needed
- Assist department on SOP revisions and conducting laboratory investigations of OOS and OOT related deviations
- Document and maintain LUMACs on assigned equipment
- Maintain the cleanliness of clean rooms and designated areas, as assigned
- Attend and participate in group and project meetings
- Assist in QC inventory of materials used
- Assist in special projects, as assigned, and other duties by manager
SKILLS/QUALIFICATIONS:
- Detail oriented and organized with the ability to accurately record data and document all activities
- Team player with excellent communication skills
- Ability to multitask
- Ability to demonstrate aseptic technique
- Sterility, endotoxin, mycoplasma, gram stain cell counting and viability
- qPCR experience is a plus
EDUCATION/EXPERIENCE:
- Bachelor’s degree in Biology or Microbiology
- Familiarity with microbiology laboratory techniques
- Experience in cGMP laboratory experience a plus
PHYSICAL DEMANDS & WORK ENVIRONMENT:
- Must be able to work around biohazardous materials (ex., human adipose tissue) and chemicals (ex., disinfectant and sporicidal agents)
- Must be able to work in a cleanroom environment with full personal protective equipment
- Able to lift 20 lbs.
- Must be willing to work on weekends and or holidays if needed
REPORTS TO: Quality Control Manager
DEPARTMENT: Operations – Quality Control
Apply Now
Celltex Therapeutics Corporation is a U.S. Equal Opportunity Employer.