Gena Monroy

Job Title: Quality Assurance Technician I (Immediate Need)

Pay rate: $25-$27 hourly  Schedule : 1:30pm-10:00pm  Start Date: ASAP We are seeking a Quality Assurance Technician I for a temp to hire opportunity with a local pharmaceutical manufacturer in Irvine!  The Quality Assurance Technician I Responsibilities:

• Issues labeling to the packaging department and records issuance on packaging records.
• Maintains labeling reconciliations and documentation as required by SOP’s and good manufacturing practices (GMPs).
• Coordinates the approval or rejection of all labeling as well as the destruction of current labeling inventory which may have become obsolete.
• Performs labeling activities (inspection, count, maintain locations and inventories in the inventory system, etc.) as required by SOPs. 
• Performs serialization labeling tasks as required. 
• Performs in-process inspections and physical testing of products to ensure compliance with specifications, including but not limited to bulk and tapped density, weight variation, friability, disintegration, and LOD.
• Performs inspection and sampling of incoming raw materials and retest materials for delivery to the Quality Control Laboratory according to established SOPs.
• Completes raw material receipt records, ensures proper labeling of raw material containers, executes release or other disposition of raw materials, and operation and maintenance of the sampling chamber in accordance with standard operating procedures.
• Maintains all analytical equipment and instrumentation utilized for QA physical testing in accordance with written procedures.
• Coordinates collection of finished goods samples for reserve/retain samples.
• Performs review of In-process QA testing data in a timely manner.
• Performs batch record review for accuracy and completeness. 
• Complies with cGMP regulations and follows all standard operating procedures. 
• Other related duties as required.

The Quality Assurance Technician I Requirements:

• High school diploma or general education degree (GED).
• 2+ year experience in a Quality Assurance environment and/or chemistry laboratory is preferable.
• Pharmaceutical experience required
• Solid organization, attention to detail, and communication skills, both written and verbal.
• Ability to routinely lift and move up to 50 pounds. 
• Able to stand for long periods of time.
• Able to apply basic math concepts
• Able to work with others in a positive team environment.

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