Senior Quality Assurance Specialist

3 weeks ago


San Antonio, United States Extremity Care Full time
Job DescriptionJob DescriptionSalary: $60,000.00

Purpose:

The Senior Quality Assurance Specialist is responsible for verifying operational compliance with the quality system and ensuring that all products and quality control processes meet established quality requirements.


Duties & Responsibilities:

  • Review HCT/P donor records in accordance with standard operating procedures and regulatory
  • Review quality control records to include equipment cleaning/maintenance, environmental monitoring, and supply inspections.
  • Inspect HCT/P products in accordance with standard operating procedures and regulatory
  • Sort and segregate acceptable and unacceptable HCT/P
  • Assist with review and processing of document change requests and change control
  • Assist in routing, editing, and finalizing controlled documents, ensuring consistency and compliance to formatting and template requirements.
  • Assist with development of equipment and process
  • Review of validation execution
  • Initiate, review, and investigate quality
  • Support and/or perform internal and external
  • Support new projects and product
  • File and maintain records in accordance with standard operating
  • Maintain a proficient working knowledge of FDA 21 CFR 1271, AATB Standards, cGMP/cGTP, and the organizations Policies and Procedures
  • Starting your job duties on time, staying on the job throughout the assigned shift to complete duties properly, and attending all scheduled meetings and appointments
  • Perform other related duties as


 Skills & Abilities:

  • Excellent attention to detail and organizational skills.
  • Self-motivated.
  • Ability to work in a fast-paced environment.
  • Effective verbal and written communication skills.
  • Ability to secure and maintain a favorable background investigation and clearance

 

Education & Experience:

  • Bachelor’s degree in biological science or related field
  • At least 3 years in an FDA regulated environment for HCT/Ps and/or medical devices (or related field).


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