Mission
The Quality Assurance (QA) Specialist provides quality oversight of internal and external activities, documentation and processes to assure compliance with company procedures and FDA regulations and assists with tasks necessary to achieve departmental and company goals.
Reporting Relationship
• The Quality Assurance Specialist will report directly to the Associate Director of Quality Assurance or designee.
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.
• This job description is subject to change at any time.
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
Physical Requirements
• Physical demands: (check one)
☐ sedentary (< 10 lbs.)
☒ light work (< 20 lbs.)
☐ medium work (< 50 lbs.)
☐ heavy work (< 100 lbs.)
☐ very heavy work (> 100 lbs.)
• Physical activity: (check all that apply)
☒repetitive motion
☐ balancing
☐stooping
☒lifting
☐climbing
☒kneeling/crouching
☐crawling
☒reaching
☒standing
☒ typing/grasping
☒walking
☒pushing/pulling
☒hearing
• Visual acuity: reading, writing, preparing/analyzing data
• Working conditions: indoor office environment and lab area
Supervisor Responsibilities
• This position does not require previous supervisory experience.