Quality Assurance Technician

3 months ago

Allentown, United States Advantage Technical Full time

Quality Assurance Technician (Process Control)


Position Location: Allentown, PA


Position Type: Contract


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


Responsibilities:

  • Perform Acceptable Quality Level (AQL) inspection of finished product for defects, leaks, and particles.
  • Perform batch record review to ensure compliance with Drug Master File (DMF) and associated Standard Operating Procedures (SOP).
  • Works with Lead to investigate product/procedure non-conformances/process deviations/product complaints and assist with formulating appropriate corrective actions and recommendations for product dispositions. Oversee site-wide quality compliance according to our client's standard
  • Operating Procedures (SOPs) & specifications, quality review of documents, label control, assist with release activities.
  • Perform document review of compounding activities such as cleaning records, destruction logs, incoming raw material forms, line clearance forms and inventory sheets and ensure documents are filed appropriately.
  • Perform incoming raw material sampling, inspection and release for Operations after verifying that all raw materials meet specification.
  • Perform inspection and release of incoming pre-printed labels. Release pre-printed labels to operations for batch use. Inspect/approve pre-printed labels and client specific printed labels for batch production labeling.
  • Assist with equipment calibration program and maintenance record files.
  • Assist with environmental monitoring program.
  • Assist on completion of product investigations and CAPAs for compounded preparations sterile products.
  • Other tasks may be assigned as deemed necessary by the Quality Lead


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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