at Astrix Technology in Des Plaines, Illinois, United States
Job Description
QA Specialist IV
Quality Assurance
Des Plaines, IL, US
Pay Rate Low: 34.50 | Pay Rate High: 40.00
+ Added – 20/02/2024
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Our client, a global healthcare leader whose portfolio of life-changing technologies spans the spectrum of healthcare, is looking for a QA Specialist to join their growing team! With an innovative product range from diagnostic and generic medications to medical devices and beyond, you will have the opportunity to grow your career and make a true difference!
Pay: $34-40/hr
Shift: 1 st shift
Job Type: Contract
Location: Des Plaines, IL
Key Responsibilities:
+ Automation equipment / process validation support and supports the validation of high-volume automation equipment and processes as ADC quality approver.
+ Generate exception/CAPA documentation such as non- conformance reports and investigation reports required at the site for routine and non-routine manufacturing issues.
+ Independently investigate all aspects of the exception event and determine the root cause, product impact, risk impact, corrections, and corrective/preventive actions.
+ Utilize device design history files, specifications, test methods, factory data, field data, or quality policies as necessary to support decisions.
+ Coordinate/facilitate meetings and/or communicate cross-functionally to develop solid solutions to CAPA activities.
+ Work with Quality, Technical Operations, Manufacturing, Engineering, or purchasing as needed to recommend/document appropriate corrections, corrective/preventive actions based on facts obtained during base CAPA investigations.
+ Concurrently manage multiple CAPA projects and tasks, ensuring timely completion.
+ Track and trend CAPA related information, as appropriate, to meet compliance requirements.
+ Be key contributor of CAPA team in identifying, developing, and implementing process or product improvements.
+ Support the creation, implementation and modification of product and process related documents including Operating Procedures and other related documents.
Education/Experience:
+ BS degree and/or 6+ years equivalent experience.
+ Assures the quality of manufactured products and processes per SOPs and GMPs.
We are an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability status, protected veteran status, or any other characteristic protected by law.
