Test Job

Discipline: Manufacturing & Production, Process, Safety, Regulatory, Regulatory Affairs
Required Education: Bachelors Degree
Position Type: Full time

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

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

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