Quality Assurance Specialist–Manufacturing Compliance (2nd Shift)

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. We’re 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 CAPA’s 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 SOP’s, 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 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 approp