Job Description

Schedule: Monday to Friday - 8:30am to 5pm with possible weekends as needed. 

• Performs inspection, sampling and testing where applicable on all incoming materials, packaging components, and return good following detailed written procedures.
• Ensures smooth flow of raw material, critical material testing through routine follow-up with internal and external laboratories.
• Perform the cleaning and sanitization of ISO 7 area and ISO 5 Laminar flow hood, as per written procedures.  
• Assigning and verification of expiry date and retest date for all the GMP raw materials through vendor COA and/or in-house COA.  
• Perform review and release of Raw Materials, and Critical Materials.
• Review of documentation supporting batch, laboratory, warehouse, metrology, engineering and validation activities to ensure they are complete and in compliance with company policies and procedures and cGMP requirements.
• Review of documentation supporting quality event system investigations (e.g. change control, deviations, out of specifications, complaints, etc.) prior to final disposition.
• Assist with quality assurance procedures governing the facility quality event system and ensure compliance with cGMP regulations, customer expectations and company policies.
• Ensure quality events are appropriately cross-referenced and that completed events are included in batch documentation prior to final disposition.
• Perform quality assurance walk-through audits of manufacturing, laboratory, and warehouse areas to ensure compliance with cGMP’s and company procedures.
• Provide back up for other Quality Assurance Specialist responsibilities.
• Assist and provide input as part of a project team to resolve quality and manufacturing issues and identify and implement corrective and preventive actions in a timely manner.
• Assist on broad spectrum of projects to support the needs of Quality Management.
• Perform other duties and responsibilities as delegated by Quality Management.