QUALITY ASSURANCE SPECIALIST

Job Description

Job Description

RESPONSIBILITIES :

• Performs initial, in-process and final inspections during manufacturing / packaging of product; resolves inspection findings with Packaging Manager and / or QA Manager.
• Collects product samples for product release testing, process validation testing and product stability as applicable and prepare labels at completion of packaging.
• Prepares documentation and forward samples to QC Lab for required testing; records information on batches in-process of testing on QC board; notifying QC of any urgent testing.
• Monitors incoming materials as received in Quarantine.
• Reviews material received paperwork and compare to material received for accuracy; notifying Materials Department to call supplier if CofA has not been received or CofA is incomplete.
• Coordinates with production areas to anticipate material usage to meet required schedule.
• Prepares required approval documentation for component or raw material inspection or testing.
• Collects raw material samples, label and forward with appropriate documentation to QC lab.
• Reviews lab data and approve / reject raw materials for use in production.
• Inspects components including bottles, tubes, closures, boxes, cartons, labels, inserts, etc., requiring visual inspection, measurements, and reading of printed information for accuracy; verifying results with an additional QA employee.
• Labels approved material or component; records in management software; forwards approved Purchase Order to accounting; notifies materials handling for approval to move to “approved materials” location.
• Labels rejected material or component, moves to reject area and notify QA Manager.
• Issues batch numbers as required per manufacturing schedule.
• Coordinates with QA Manager to determine if batch will be a designated validation or stability batch.
• Prepares product batch documentation folder; completing information for batch number, product expiration and fill weights as applicable; obtains verification from an additional QA employee.
• Issues executed appropriate departmental batch documentation for production areas.
• Reviews batch records for completeness and accuracy; resolves disputes with Production Manager.
• Investigates any discrepancies in material / component usage or product yield; coordinates with QA Manager upon review of laboratory results to determine product disposition; holding some product for further packaging processes (bright stock); requiring additional documentation preparation and inspection processes.
• Notifies shipping department of released status on approved product; forwards rejected documentation to QA manager for review.
• Performs inspection when product pallets have been prepared for shipping to verify product name, lot number, product count, address and verify inventory reduction against customer Purchase Order.
• Performs other related duties as required.

QUALIFICATIONS :

At LGM Pharma, we always take pride in putting our people first. We are an equal opportunity employer. We offer medical, dental, vision and company matching 401K.

All suitably qualified candidates will receive consideration for employment based on objective work-related criteria and without regard for the following : age, disability, ethnic origin, gender, marital status, race, religion, responsibility of dependents, sexual orientation, or gender identity or other characteristics in accordance with the applicable governing laws.