Quality Assurance Technician

2 days ago


Allentown, United States Advantage Technical Full time

Quality Assurance Technician


Position Location: Allentown, PA


Position Type: Contract


Position Hourly Rate: 22/HR – 23.93/HR (Depending on Experience)


Tuesday - Saturday : 2nd Shift (2:30 - 11:00) or 3rd Shift (10:45PM - 7:15AM)


# of Roles: 3


Responsibilities:

  • Perform product inspection for defects, leaks and particulates.
  • Perform environmental monitoring of personnel (as needed) and complete documentation.
  • Assist in the media fill process validations to include inspection of filled units
  • Perform document review of compounding activities such as cleaning records, line clearance forms and inventory sheets:
  • Verify that raw materials meet specification
  • Verify and account for labeling
  • Review temperature and BMS alarms
  • Verify that product test results meet specification limits
  • Verify that all documentation is complete
  • Document non-compliance and work with supervisor/lead if further investigation is needed
  • Submit samples to the appropriate lab for particulate identification or microbial analysis.
  • Assist with equipment calibration program and maintenance record files.
  • Assist with raw material release and movement.
  • Under the direction of supervisor/lead, document and initiate quality events for deviation and complaint investigations.
  • Support internal & external audits.
  • Maintain quality records (equipment calibration and maintenance, training, deviation and complaint investigation, environmental monitoring, Certificate of Analysis, clean room certification etc.).
  • Working hours: 2:30pm-11:00 pm. (Training will be completed on 1st shift 8:30-5:00pm for the first month). We need them ASAP.


Requirements:

  • High School Diploma / GED a minimum; Higher education is considered plus
  • 2+ years experience working in a lab setting environment, clean room or similar background is required.
  • GMP experience and Particle testing / Endotoxin testing experience is highly preferred.
  • Excellent communication skills are required
  • Able to work indoors, working environment limited to a small area, wearing protective laboratory



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