Sr. Quality Control Scientist (Data Integrity and Lab Compliance)
Eli Lilly
- Branchburg, NJ
- Permanent
- Full-time
- Own the responsibility for building/sustaining Quality and Data Integrity principles into computer system life cycle processes working in collaboration with Compliance leadership.
- Own DI compliance in the QC Laboratories and implement DI improvement plans.
- Provide training, coaching, feedback and mentoring to lab personnel on DI principles/regulations.
- Participate in the design and delivery of learning opportunities for lab personnel with the purpose of strengthening the Quality/DI Culture (leveraging the network of functional DI SMEs/DI Champions).
- Serve as a site quality representative on global DI-related forums, providing feedback to the site for opportunities or concerns.
- Represent the lab as a member on the site Data Integrity governance committee.
- Develop deep knowledge of laboratory system design and intended use in GMP operations to assess DI user requirements.
- Perform and facilitate Data Life cycle Process Maps to identify DI risks and define mitigation strategies.
- Perform, facilitate and support DI improvements to documents, systems and processes.
- Lead or take part in Quality walk-throughs, internal audits, etc. (proving technical input and system design awareness) to ensure systems are used/maintained in a state of control. Create DI-related actions and lead efforts to implement such actions.
- Create, track and communicate DI-related KPIs and metrics, trending Quality-related DI deviations with the business and identify areas of concern and opportunity.
- Support the assessment and effectiveness checks of Quality records (Change Controls, Deviations, Trends, etc.) for Data Integrity impact where appropriate.
- Serve as a SME for DI-related inquiries / training.
- Ensure Data Integrity readiness for regulatory authority inspections and participate in such inspections as necessary.
- Ensure compliance with applicable Lilly global standards and regulatory guidelines.
- Continuously improve Data Integrity knowledge-base and understanding.
- BA/BS degree in the sciences, engineering, or related field with a minimum of 3-5 years of experience in GMP operations, preferably within the Biopharmaceutical industry.
- Previous technical experience related to computer systems validation, system/software development lifecycle, GAMP, 21 CFR Part 11 compliance, and data integrity controls in a GMP regulated environment.
- Must possess working knowledge of domestic and/or international GMP regulations and other policies/regulations as applicable.
- Must have experience leading small/medium sized projects.
- Possesses a strong understanding of IT system design, controls, usage and Data Integrity requirements/regulations.
- Experience in conducting data integrity assessments of current-state practices, procedures, system functionality, including but not limited to physical/logical security, ER/ES, audit trails, data mapping, record storage/retention, computer system validation, infrastructure qualification, data back-up/restore/archival, investigation, and training programs.
- Must have the ability to function in a fast-paced, cross-functional environment and communicate effectively with management.
- Will be required to complete the global CSQA Qualification Program.