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Quality Assurance Specialist - Bethlehem, PA 18015


Praxair



Job details

Job Type

Full-time

Full Job Description

Quality Assurance Specialist

  • 21001543


Praxair, Inc. is a leading industrial gas company in North and South America and one of the largest worldwide. Praxair produces, sells and distributes atmospheric, process and specialty gases, and high-performance surface coatings. Our products, services and technologies are making our planet more productive by bringing efficiency and environmental benefits to a wide variety of industries, including aerospace, chemicals, food and beverage, electronics, energy, healthcare, manufacturing, primary metals and many others. For more information about the company, please visit our website at www.praxair.com.

 

Praxair Distribution, Inc. is seeking a Quality Assurance Specialist to join our team located in Bethlehem, PA.

 

The Quality Assurance Specialist will be responsible for reviewing and ensuring all steps in the manufacturing, testing, storage and distribution process for medical products at the Bethlehem Facility and are performed in accordance with FDAís applicable regulations and PDIís standard operating procedures. The Quality Assurance Specialist will handle the quality oversight and auditing of production and incoming inspection activities, review of change requests, and investigation of non-conformances and out of specification reports. The Quality Assurance Specialist will have the ability to work independently and to provide consultative advice within specific areas of expertise.

Quality Assurance Specialist

  • Reviews all steps performed and ensures that the step in the manufacturing process has taken place as defined in the Batch Production Record.
  • Reports findings of in-process errors and provides follow-up to ensure adequate completion of corrective actions.
  • Performs and coordinates quality investigations with appropriate levels of corrective/preventive actions and closes in a timely manner.
  • Supports product quality complaint investigations, assisting in data processing of Adverse Events and appropriate reporting for U.S. and Canada complaints. Supports the receipt/review of product complaint samples. Participates in the investigation and resolution of non-conformances of all types.
  • Quality review of System Preventative Maintenance activities.
  • Support initiatives in Continuous Quality Improvement.
  • Provides training in GMP and quality principles to personnel in all departments when assigned. Assists in maintenance of training schedules and training records systems.
  • Assists in the review and approval of Change Controls.
  • Assists in internal and supplier audits and establishing/updating supplier and component specifications and testing as needed.
  • Assists with tracking and trending of deviations and complaints.
  • Follows all safety rules/regulations and immediately reports infractions and/or workplace injuries/accidents to proper personnel.
  • Ensures for product disposition, e.g., approvals for release, distribution or rejection.
  • Ensures labels are appropriately reviewed and approved for use and meet all internal and external requirements
  • Other duties as assigned

 

  • Bachelorís/Associates Degree in a Science/ Engineering or related technical field
  • Background in quality medical products preferred
  • Knowledge in the FDAís regulations for medical products 21 CFR part 210 and 211
  • Strong communication skills & organizational agility
  • Solid organizational skills
  • Strong knowledge of Microsoft Office Applications and Lotus Notes database skillsets
  • Basic of HTML and JavaScript computer language preferred
  • ISO 9001 or ISO 13485 and or regulatory experience

All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, age, disability, protected veteran status, pregnancy, sexual orientation, gender identity or expression, or any other reason prohibited by applicable law.

Primary Location Pennsylvania-Bethlehem

Schedule Full-time

Job SHEQ

Unposting Date Ongoing

 

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