What are the responsibilities and job description for the QA Engineer Specialist position at Integrated Resources?
Job Title : QA Engineer Specialist
Job Location : Warren, NJ
Job Duration : 12 Months
Purpose and scope of position :
The Specialist, QA Engineering is responsible for ensuring quality, integrity, and compliance of site Information Technology (IT) systems, review of validation and qualification documents for all equipment and facility activities. This position is a member of the Cell Therapy Development and Operations (CTDO) organization, which supplies autologous and allogeneic cell therapies for first-in-human and pivotal clinical trials.
Knowledge, Skills, and Abilities :
- Must have advanced knowledge and experience with GMP, Quality and compliance.
- Previous experience as a computer system validation / quality assurance for life sciences company regulated by the FDA is preferred.
- Advanced level experience in design of user requirement specifications, IQ / OQ / PQ protocols, user acceptance testing and other equipment / facility qualification documentation.
- Must be fluent in standard Microsoft Office software; experience in asset management software (e.g. Blue Mountain RAM) and quality systems software (e.g. Veeva).
- Drives use of best practices during IT systems design, validation, and use.
- Must be able to recognize and group technical / scientific attributes and drive science-based decisions in most technical areas.
- Must manage development of technical or scientific initiatives and activities by interdisciplinary teams.
- Must be able to critically review investigations and reports, interpret results, and generate technical conclusions consistent with Quality risk management principles.
- Intermediate knowledge of quality systems including CAPA, change control, and document management systems.
- Requires minimal direction to complete tasks, authority to make daily decisions that impact their team.
- Negotiates solutions cross-functionally. Drives continuous improvement and improves efficiency and productivity within the group or project.
- Consults management for advice on complex issues.
- Able to prepare written communications and communicate problems to management with clarity and accuracy.
- Drive strong collaboration within the site and across the network.
Duties And Responsibilities :
Education And Experience :
