Senior Quality Assurance Engineer

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:

• Functional responsibilities include ensuring accurate and timely maintenance of validation and qualification documents for all equipment and facility activities; investigations and evaluation of change control.
• Ensure IT systems are designed, setup and function in a GMP-compliant manner to safeguard and maintain the safety and quality of BMS’s products.
• Provides QA oversight on key software development life cycle (SDLC) processes such as problem, incident, change, release and deviations.
• Support the Qualification and Validation activities in relation to QC and manufacturing equipment and facility design.
• Assures appropriateness of calibration/maintenance programs, validation plans, qualification protocols, associated reports and procedures.
• Support ECQ, Facilities, QC and manufacturing equipment-related investigations in ensuring appropriate and thorough impact assessment, root cause analysis and corrective/preventive actions are documented and implemented.
• Ensures compliance with the site validation master plan, assist with facility start-up operations and product transfers supporting the Qualification and Validation teams.
• Work with Engineering/Facilities/ECQ management to ensure functional activities comply with global regulatory requirements.
• Sponsor and support the change initiatives and the implementation of process improvement initiatives.
• Ensure site is compliant with global and regulatory data governance and data integrity requirements.
• Support any other goals and objectives of the site Quality Assurance organization, as needed

Education And Experience:

• B.S. degree required.
• 8 years of experience in the pharmaceutical or related industry required
• Equivalent combination of education and experience acceptable.