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Quality Assurance Specialist II

2 months ago

Fort Worth, Texas, United States Smith+Nephew Full time
Job Summary

Smith+Nephew is seeking a Quality Assurance Specialist II to provide quality oversight of manufacturing operations. The successful candidate will be responsible for reviewing in-process documentation, providing quality input and decision-making for quality and manufacturing issues, and performing quality inspections on the shop floor.

Key Responsibilities
  • Provide quality oversight of manufacturing operations, including review of in-process documentation and facility and equipment usage.
  • Provide quality input and decision-making for quality and manufacturing issues as they arise on the shop floor.
  • Perform quality inspections on the shop floor, including AQL sampling/inspection of in-process intermediates and finished products.
  • Provide quality approval of manufacturing procedures, batch records, and forms, and quality sign off for process equipment/utilities calibration and preventative maintenance activities.
  • Support the QA Validation function by providing review and approval of validation protocols and/or reports for the validation of manufacturing equipment and processes.
  • Release of product for specific manufacturing phases and QC support processes.
Requirements
  • Bachelor's degree in science or engineering.
  • 2-5 years relevant experience in the pharmaceutical/biotech/medical device industry.
  • Experience in manufacturing or quality assurance functions preferred.
  • Strong analytical skills, problem-solving techniques, and technical skills.
  • Ability to work well with all levels of personnel throughout the facility.
  • Capable of rapidly absorbing large amounts of information and technical data regarding equipment and processes and apply this knowledge to the manufacturing environment.
Working Conditions
  • Occasional use of chemical may be required.
  • Physical Risk (Personal Protective Equipment – PPE): Use of PPE will be required as per local procedures.
  • Must be able to walk/stand for long periods of time donned in cleanroom garments.
Benefits
  • Competitive salary and benefits package.
  • Opportunities for professional growth and development.
  • Collaborative and dynamic work environment.

Smith+Nephew is an equal opportunities employer and welcomes applications from all qualified candidates.