Lilly Quality Assurance Compliance Specialist (FUME) in Branchburg, New Jersey
At Lilly, we unite caring with discovery to make life better for people around the world. We are a global healthcare leader headquartered in Indianapolis, Indiana. Our 35,000 employees around the world work to discover and bring life-changing medicines to those who need them, improve the understanding and management of disease, and give back to our communities through philanthropy and volunteerism. We give our best effort to our work, and we put people first. We’re looking for people who are determined to make life better for people around the world.
At Lilly, we serve an extraordinary purpose. We make a difference for people around the globe by discovering, developing and delivering medicines that help them live longer, healthier, more active lives. Not only do we deliver breakthrough medications, but you also can count on us to develop creative solutions to support communities through philanthropy and volunteerism.
Independently works within the Lilly Branchburg Process Team environment per Manufacturing Standards for Operational Excellence (MSOE), resolves key technical/quality problems and drives solutions that impact the site. Leads medium-scale projects or programs with moderate risk and/or complexity. Provides assistance to cross-functional groups and/or management with troubleshooting investigations and problem resolution. Assists with implementation of quality improvement plans. Provides QA presence in areas of responsibility (Facilities, Utilities, Maintenance, and Engineering (FUME)) by conducting periodic walkthroughs. Ensures regulatory compliance and procedural consistency between manufacturing facilities. Prepares cross-functional partners for Regulatory Inspections. Provides assistance, where necessary, during regulatory/partner inspections. Ensures compliance observations associated with Lilly Branchburg Manufacturing Facilities are adequately addressed and completed on schedule.
Evaluate deviations and ensure appropriate root cause/likely assignable cause(s) and assess quality impact. Recommend CAPAs and ensure CAPAs implemented are effective. Review and approve respective development and validation documentation. Evaluate change controls and associated risk assessments. Perform training within group or throughout organization as needed. Write/escalate Notifications to Management, as applicable. Ensure timely completion of all quality plan objectives and milestones. Support the on-time performance metrics. Assist in creating quality metrics. Keep Quality management informed of compliance issues. Perform periodic walk-throughs of facilities. Assist in activities associated with technology transfers to and from Lilly Branchburg facilities, as applicable. Attend and serve as a key resource in ad-hoc meetings to provide compliance guidance to Facilities, Engineering, and Validation issues. Ensure compliance with applicable regulatory guidelines and GxP computer systems to global electronic records/signatures regulations (21 CFR Part 11, Annex 11, etc. as applicable); Perform review of regulatory submissions as necessary. Perform the compliance and risk evaluation of respective systems and departments. Participate in internal audits performed by partners, Lilly corporate, and/or regulatory agencies, as applicable. Identify and lead a process improvement projects that impact systems used in a specific functional area. Serve as core member on Process Team(s), a cross functional group charged with making medicine, continuous improvement, and site support in accordance with Manufacturing Standards of Operational Excellence. Serve as key Quality liaison between disposition and compliance by supporting lot release through ensuring timeliness resolve of compliance issues, as applicable. Perform Analysis Audit Trail Reviews.
BA/BS degree in the sciences (engineering preferred) with a minimum of 1-3 years experience in the Biopharmaceutical industry. Previous technical experience should be in biotechnology manufacturing processes and/or computer systems (large scale cell culture, purification processes, validation).
Must possess working knowledge of domestic and international GMP regulations and other policies/regulations as applicable. Must have experience in developing, reviewing and/or approving the following types of development/validation documents: Validation Plans, User/Functional Requirement Specifications, IQ/OQ/PQ Protocol and Reports, Requirements Traceability Matrix, and Validation Summary Reports. Must possess a conceptual understanding of all Quality functions and business areas. Must possess depth and/or breadth of expertise within area of responsibility. Must have the ability to function in a fast-paced environment and communicate effectively with management. Must be able to work in a cross-functional environment. Must have demonstrate ability to work independently. Must be proficient in Microsoft applications.
Travel required, approximately 10%. Lifting not required. Required to be on call. Shift work may apply.
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Lilly is an EEO/Affirmative Action Employer and does not discriminate on the basis of age, race, color, religion, gender, sexual orientation, gender identity, gender expression, national origin, protected veteran status, disability or any other legally protected status.
As a condition of employment with Eli Lilly and Company and its subsidiaries in the United States and Puerto Rico, you must be fully COVID-19 vaccinated and provide proof of vaccination satisfactory to the company (subject to applicable law).