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