AGTC is seeking a highly motivated individual who will be part of a team responsible for designing, maintaining and improving quality systems that are applicable to internal and external product development activities.
• The Quality Affairs Specialist will report directly to the Director of Quality Assurance.
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
• Assist in management and control of laboratory and manufacturing documentation, including SOPs, study protocols, study reports, batch production records and other controlled documents
• Review manufacturing batch records and quality control data to assess for completeness and accuracy and ensure any deviations are appropriately addressed in support of the timely disposition of nonclinical and clinical drug products
• Provide internal training to laboratory and manufacturing staff on GMP/GLP regulations and QA requirements; maintain training documentation system
• Provide QA support for maintenance and calibration of laboratory equipment; assure calibrations are performed and documented on a timely basis and records are maintained
• Interface with contract manufacturing/testing organizations and alliance partners to resolve quality-related issues with minimal supervision
• B.S. degree in a scientific discipline and 3 to 5 years’ experience working in a GLP/GMP environment, preferably in a biotechnology company
Experience, Knowledge, Skills and Abilities
• In-depth understanding of GLP and GMP regulations, guidance documents, systems, processes and procedures
• Great attention to detail
• Strong interpersonal skills
• Effective communication skills both verbally and written
AGTC offers a competitive compensation commensurate with education and experience, including salary, benefits, and company equity. AGTC is an EOE and maintains a drug free workplace.