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Quality Assurance (QA) Specialist - Process Validation

Job Description

Azzur Group is seeking a Quality Assurance (QA) Specialist to join our growing company and work on client projects involving process validation -  performance qualification (PPQ) and review of commissioning and qualification documents, including Manufacturing Batch Records (MBR). Duties include:



  • Completes Document Preparation, Review and Field Execution activities for qualification and commissioning of manufacturing equipment.

  • Maintain and track documentation and handle change control (CC) and deviations/corrective actions.

  • Provide support to related manufacturing activities and attend meetinsg as needed.


Qualifications:



  • BA/BS degree or combination of equivalent education and QA/Validation work experience

  • Two plus years experience in equipment qualification and commissioning in a Life Science/FDA regulated environment; experience with HVAC and Washers desirable

  • Experience with related SOP's, regulations, standards, specifications and other documentation

  • Good communication, analytical, computer & organizational skills; attention to details

  • Ability to effectively work independently in a deadline driven team environment



Company Description
Azzur Group is a private equity enterprise supporting and growing an interwoven network of companies focused on the health and life science (HLS) sector, including pharmaceutical, biotechnology, medical devices & diagnostics, clinical research, and related HLS suppliers. Azzur companies provide a wide-range of business-to-business professional services and solutions, evidenced by our broad scope of services and thought leadership. As one of the fastest growing private companies in America, Azzur is on a mission to bridge the talent and capability gaps that often confound our customers, from Discovery to DeliveryTM.
Azzur's Consulting practice is a GxP compliance and consulting organization dedicated to providing high quality, expertly backed, assistance that drives life science companies to success. We are seeking highly motivated and talented individuals to join our incredible team of skilled problem solvers. Qualified candidates must have a desire to learn, apply, engage, and adapt in the ever-changing work environment while simultaneously and organically exuding Azzur's core values: Do what's right.......Put others first......Courage to Take action......Take personal responsibility....Have fun!



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