As a Senior Associate Scientist - Empower and Computer Systems Analyst, you will be reporting to the Global Supply Division. Every action you undertake daily at Pfizer will have a direct and significant impact on patient health and wellbeing. Your dedication to delivering safe, high-quality products will drive your work and contributions to our science-based, risk-aware, and compliant quality culture. Whether you are engaged in development, maintenance, compliance, or analysis through our research programs, your efforts will help us remain adaptable, pioneering, and customer-focused in our approach. Your role directly contributes to improving patients' lives globally by ensuring the highest quality standards in our operations.
The position will support the Pfizer Sanford, NC Quality Control department by performing QC System Administrative activities associated with the Empower and NuGenesis applications. This position requires the demonstrated capability to provide strategic direction to System Administrator projects (for example, computerized system maintenance) by defining project solution, strategies and insuring effective implementation and delivery as part of the overall project execution plan. Key responsibilities are performing Data Integrity (DI) assessment projects and then executing the resulting remediation activities (for example, System upgrade project). This includes implementing DI control strategies (both technical and procedural controls) in the lab and influencing the DI/Compliance culture across the Quality Organization and troubleshooting of connectivity issues of all types: instrument/equipment/network/computer issues. Additional responsibilities include providing support for lab instrument validation activities. Also, must maintain Empower documentation (e.g., Empower procedures). Additionally, performing change controls for document revisions, creating/reviewing/executing/approving activities for GMP tasks/activities associated with maintaining compliant Quality Control laboratories, participating in investigations of events, acting as a change agent, and driving continuous improvement/Operational Excellence/innovative implementations; and support site Empower liaison with Center Empower requests.
In this role, you will:
Contribute to intricate projects by managing your time effectively and developing individual project plans within a team.
Utilize your skills and discipline knowledge to enhance the Empower, Nugenesis, and Validation Team’s efforts.
Recognized as a ‘go-to” person for Empower system troubleshooting and having technical knowledge of lab data systems and the related instrumentation used within QC.
Make informed decisions to solve moderately complex problems, adhering to guidelines and policies, even in ambiguous situations.
Ensure compliance with established standards and agency guidelines for quality programs, processes, and procedures.
Collaborate with site and off-site Digital colleagues to troubleshoot issues and to develop and deliver innovative solutions, best practices, and technical guidelines.
Develop and maintain quality assurance programs and policies to promote uniform standards and best practices globally.
Use your judgment to modify methods and techniques, especially in technical aspects of injector functionality, component testing, and protocol execution.
Operate under general supervision, following established procedures and general instructions.
Tackle loosely defined problems within the Work Team, with your work periodically reviewed for oversight.
Mentor colleagues by reviewing their work as necessary, under the guidance of established procedures.
Acting safely, knows and follows all EH&S safety requirements for site and QC laboratories; leads safety initiatives and encourages others to act safely
Receives feedback well from management and other colleagues, grows self-utilizing feedback and takes accountability for actions and personal development
Collaborate/independently engage with a wide range of co-workers, customers, and management within the Network to gather the input and background knowledge needed to complete assignments
Consistent correctness and accuracy in tasks, activities, decisions, and documentation; detail-oriented behavior
Support additional system administration related activities within QC Laboratories such as data archival activities, equipment and electronic system implementation and troubleshooting, maintenance of end user accounts, equipment considerations relating to data integrity, etc.
