Phoenix, Arizona
Quality Assurance Associate Job Opening in Phoenix, Arizona - Purpose :
The purpose of this position is to be responsible for promoting quality standards within the center and ensuring that quality policies and procedures are followed by center personnel. Operates within the scope of EU Guidance on Good Manufacturing Practice and FDA cGMP 21CFR.
Key Accountabilities :
Assists with review of manufacturing activities, determines if records are in compliance with SOP and regulatory requirements, and ensures corrective actions as needed.
May perform final QA review and release for all product shipments and associated documents to ensure shipments meet customer specifications.
Ensures data integrity by auditing the manufacturing process to ensure the completeness, consistency, and accuracy of records and documents within the quality system.
Communicates with management regarding daily quality assurance/quality control issues affecting donor suitability and/or product quality; develops and implements corrective actions when necessary.
Assists with or performs ongoing focused audits to ensure employees correctly perform procedures; identifies deficiencies and works closely with training staff to correct any issues noted.
Assists management and training staff in communicating SOP and regulatory changes to involved staff and ensure documentation of training is complete.
Assists in analyzing tracking and trending data and determine appropriate actions to improve trending.
Reviews center logs and records to ensure information is accurate and/or legible as outlined in the Quality System SOP and ensure corrections are made as needed.
Reviews incoming softgoods and medical supplies to ensure accurate receipt and suitability for use.
Other job-related responsibilities as required.
Job Type: Full-time
Job Location:
Phoenix, AZ
Required education:
High school or equivalent
Required experience:
Quality Assurance: 2 years
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