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QA Specialist I/II/III

Employer
AGTC
Location
Gainesville Area, FL, United States
Start date
Nov 2, 2019

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Discipline
Clinical, Quality, Quality Assurance
Required Education
Bachelors Degree
Position Type
Full time
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Essential Duties and Responsibilities
  • Support the development, implementation, and improvement of corporate quality systems that support early, mid and late phase gene therapy clinical programs
  • Increase compliance awareness and promote a culture of quality throughout the company, with a focus on laboratory and manufacturing operations
  • Collaborate with multiple functions to perform QA oversight and ensure quality-related activities are executed efficiently
  • Write, review and revise standard operating procedures
  • Provide training to laboratory and manufacturing staff on GLP/GMP regulations, best practices and internal requirements
  • Review and approve product-related documentation, including raw material release, batch records, quality control test results and resolve discrepancies, as needed
  • Perform in-phase inspections in support of GLP studies, write inspection reports and prepare QA statements
  • Review and approve Certificates of Analysis and/or Certificates of Test
  • Perform internal and external audits of GxP vendors; assist in the resolution of non-conformances, deviations and investigations.
  • Track open observations and Corrective and Preventative Actions (CAPA) to closure.
  • Assist with the analysis of trends and metrics to ensure continuous quality improvements.
  • Interface with contract manufacturing/testing organizations and alliance partners to resolve quality-related issues with minimal supervision
  • Other duties as assigned

Experience/Educational Qualifications
  • Level I - B.S. degree in a scientific discipline and no QA experience
  • Level II - B.S. degree in a scientific discipline and at least two (2) years' QA experience (5 preferred) in a GLP/GMP environment, preferably in a biotechnology company
  • Level III - B.S. degree in a scientific discipline and at least five (5) years' QA experience (7 preferred) in a GLP/GMP environment, preferably in a biotechnology company


Additional Qualifications
  • In-depth understanding of GLP and GMP (drugs and biologics) regulations, guidance documents, systems, processes and procedures
  • Great attention to detail
  • Strong interpersonal skills
  • Strong prioritization, organizational and negotiating skills
  • Excellent verbal and written communication skills and ability to communicate effectively with site personnel, peers and management
  • Solid time management skills and ability to handle multiple tasks and deliver high quality results within set timelines


Supervisory Responsibilities
  • This position does not have supervisory responsibilities


Essential Duties and Responsibilities
  • Support the development, implementation, and improvement of corporate quality systems that support early, mid and late phase gene therapy clinical programs
  • Increase compliance awareness and promote a culture of quality throughout the company, with a focus on laboratory and manufacturing operations
  • Collaborate with multiple functions to perform QA oversight and ensure quality-related activities are executed efficiently
  • Write, review and revise standard operating procedures
  • Provide training to laboratory and manufacturing staff on GLP/GMP regulations, best practices and internal requirements
  • Review and approve product-related documentation, including raw material release, batch records, quality control test results and resolve discrepancies, as needed
  • Perform in-phase inspections in support of GLP studies, write inspection reports and prepare QA statements
  • Review and approve Certificates of Analysis and/or Certificates of Test
  • Perform internal and external audits of GxP vendors; assist in the resolution of non-conformances, deviations and investigations.
  • Track open observations and Corrective and Preventative Actions (CAPA) to closure.
  • Assist with the analysis of trends and metrics to ensure continuous quality improvements.
  • Interface with contract manufacturing/testing organizations and alliance partners to resolve quality-related issues with minimal supervision
  • Other duties as assigned

Supervisory Responsibilities
  • This position does not have supervisory responsibilities.
Send job

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