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