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Quality Assurance SpecialistâManufacturing Compliance

2 months ago

Branchburg, United States Eli Lilly and Company Full time

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 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. Weâre looking for people who are determined to make life better for people around the world.

Organization Overview:

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.

This position is responsible for second shift quality compliance support of manufacturing operations. This position will interact with the manufacturing, engineering, validation, quality control and regulatory departments. Interaction may be required with other Lilly site / contract producers of Lilly products.

The Quality Professional works within Lilly cross-functional groups, anticipates and resolves problems while driving solutions for processes and/or products.  May lead small to large projects or programs with moderate risk.  Manages quality-related matters specific to area of responsibility.  Provides assistance to cross-functional groups with troubleshooting investigations and problem resolution.  Reviews batch records/manufacturing documentation and resolves comments to documentation. Assists with the implementation of change controls and/or reviews GMP documents associated with area of responsibility.   Ensures area of responsibility remains inspection ready and may support regulatory/GMP inspections.  Ensures observations associated with Lilly Branchburg are adequately addressed and completed on schedule.  Represents Quality per Manufacturing Standard for Operational Excellence (MSOE) 602 within area of responsibility.  Knowledge of cell culture, purification and support systems used in the manufacturing of biotech products is preferred.

Responsible for supporting manufacturing operations through the performance of the following duties and representing QA on Manufacturing Process Teams:

  • Evaluate and process observations, trends or deviations to determine root cause(s) and assess quality impact.  Recommend CAPAâs and ensure CAPAs implemented are effective.  

  • Evaluate change controls and associated risk assessments.   

  • Ensure sustainable compliance to all regulations related to area of oversight (e.g. 21 CFR Part 11 related to computer systems, data integrity associated with manual and electronic systems including review of audit trail information, etc). 

  • Review/approve SOPâs, Reports, Equipment/Method Qualifications/Verifications/Validations, Excursions, specifications and Work Orders for compliance to regulatory standards. 

  • Review/approve executed batch records and participate in API bulk release activities.

  • Assist in creating quality metrics.  Keep Quality Management informed of compliance issues. 

  • Assist with activities associated with technology transfers or product launches to and from Lilly Branchburg facilities. 

  • Attend and serve as a key resource in ad-hoc meetings to provide compliance guidance to Manufacturing, Laboratories, Maintenance. Validation or supporting business units. 

  • Ensure compliance with applicable Lilly global standards and regulatory guidelines. 

  • Serve as member on Process Team(s), continuous improvement, and general site support. 

  • Participate in Regulatory and partner inspections as necessary. Ensure timely follow up to any inspection findings.
     

    Basic Qualification:

  • BA/BS in Chemistry, Biology, or a science-related field; would consider candidates with Associate's degree and/or HS diploma with relevant work experience.

Minimum 1-2 years of experience in the pharmaceutical/biopharmaceutical industry.

Additional Skills/Preferences:

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. 

Additional Information:

Support hours are Four days on â Four days off from approximately 12:00 pm to 12:30 am.

Eli Lilly and Company, Lilly USA, LLC and our wholly owned subsidiaries (collectively âLillyâ) 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 ( Lilly_Recruiting_Compliance@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.

Our employee resource groups (ERGs) offer strong support networks for their members and help our company develop talented individuals for future leadership roles. Our current groups include: Africa, Middle East, Central Asia Network, African American Network, Chinese Culture Network, Early Career Professionals, Japanese International Leadership Network (JILN), Lilly India Network, Organization of Latinos at Lilly, PRIDE (LGBTQ + Allies), Veterans Leadership Network, Womenâs Network, Working and Living with Disabilities. Learn more about all of our groups.

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