Lilly Quality Assurance Specialist (Laboratory Compliance) 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 believe in the talent of our workforce. One of the best ways to utilize and develop that talent is to use our existing workforce to fill new and/or open positions. If you are looking for a new position within Lilly, you can view and apply to open roles posted in the internal job posting system. You must meet the minimum qualifications outlined in the job description and have/obtain work authorization in the country the position is located in order to be considered. When applying internally for a position, your current supervisor will receive notification that you have applied to the position. We encourage employees to discuss the opportunity with their supervisor prior to applying.
The Quality Assurance representatives support Lilly Quality Control cross-functional groups, anticipates and resolves problems while driving solutions for processes and/or products. Partners with business on/or leads projects or compliance initiatives with moderate risk. Support QA compliance management with quality-related matters specific to the QC Lab areas. Provides leadership and guidance to QC cross-functional groups with respect to deviation investigations and problem resolution.
Evaluate and process laboratory-related deviations or trends to determine root cause(s) and assess quality impact. Recommend CAPAs and ensure CAPAs implemented are effective.
Evaluate laboratory-related change controls and associated risk assessments.
Ensure sustainable compliance to all regulations related to QC Lab areas.
Provide on-site QA oversight of the laboratory areas.
Ensure compliance to data integrity requirements and perform audit trail reviews as required.
Keep Quality Management informed of compliance issues.
Attend and serve as a key resource in ad-hoc meetings to provide compliance guidance to Lab or supporting business units.
Ensure compliance with applicable Lilly global standards and regulatory guidelines.
May serve as core member on Process Team(s), continuous improvement, and general site support.
May participate in Regulatory and partner inspections as needed. Ensure timely follow up to any inspection findings.
BA/BS degree in the sciences with a minimum of 5 years of experience preferred in the Biopharmaceutical industry.
Previous technical experience should be related to area of responsibility, as appropriate.
Must possess working knowledge of domestic and international GMP regulations and other policies/regulations as applicable.
Possesses a conceptual understanding of all Quality functions and business areas.
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 be proficient in Microsoft applications.
Eli Lilly and Company, Lilly USA, LLC and our wholly owned subsidiaries (collectively “Lilly”) are committed to help individuals with disabilities to participate in the workforce and ensure equal opportunity to compete for jobs. If you require an accommodation to submit a resume for positions at Lilly, please email Lilly Human Resources ( LillyRecruitingCompliance@lists.lilly.com ) for further assistance. Please note This email address is intended for use only to request an accommodation as part of the application process. Any other correspondence will not receive a response.
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.
At Lilly we strive to ensure our employees are part of a team that cares about them and our shared purpose of making life better for those around the world. How do we do this? We continue to look for ways to include, innovate, accelerate and deliver while maintaining integrity, excellence and respect for people. We hope that you seek to join us on our journey as we create medicine and deliver improved outcomes for patients across the globe!