Associate - Quality Assurance

4 weeks 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. 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. Each Lilly employee will embrace Operational Excellence in everything we do, to achieve our mission of Making Medicine with Safety First & Quality Always; following our common purpose under TEAM Lilly and our Manufacturing Standards under the strict code of conduct guided by our Red Book assuring data integrity in all we do.

The Quality Assurance Associate independently works within the Lilly Branchburg Process Team environment to ensure Quality Systems and GMP compliance.  Provides assistance and guidance to Process Teams in deviation investigations, change control assessments, procedure and master production record revisions, validations and MES exceptions /batch record review. Also, provides QA presence in Manufacturing areas by conducting periodic walkthroughs and provides assistance, where necessary, during regulatory/partner inspections.


Responsibilities:


Manage for Results /Strategic Planning

Serve as core member on Process Team(s), a cross functional group.

Evaluate deviations and ensure appropriate root cause/likely assignable cause(s) and assess quality impact.  Recommend CAPAs and ensure CAPAs implemented are effective.

Write/escalate Notifications to Management, as applicable.

Perform periodic walk-throughs and support area changeovers of Manufacturing facilities.

Perform Data Integrity Analysis and Audit Trail Reviews.

Perform MES exceptions /batch record review.

Perform training within group or throughout organization as needed.

Attend and serve as a key resource in ad-hoc meetings to provide compliance guidance to Manufacturing issues.

Support lot release through ensuring timeliness resolve of compliance issues, as applicable.

Assist in activities associated with technology transfers to and from Lilly Branchburg facilities, as applicable.

Review and approve respective development and validation documentation. Evaluate change controls and associated risk assessments.

Support applicable on-time performance metrics.

Support audits performed by partners, Lilly corporate, and/or regulatory agencies, as applicable.

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).

Basic Requirements:

BA/BS degree in the sciences with a minimum of 1-3 years experience in the Biopharmaceutical industry.

Additional Preferences:

Must possess working knowledge of domestic and international GMP regulations and other policies/regulations as applicable.

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 team environment.

Must have demonstrate ability to work independently.

Must be proficient in Microsoft applications.

Previous technical or QA experience in biotechnology manufacturing processes and/or computer systems (large scale cell culture, purification processes, validation) is preferred.

 

Additional Information:

Travel required, approximately 10%.

Lifting not required.

Required to be on call.

Shift work may apply.

​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.

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 ( 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, Women’s Network, Working and Living with Disabilities. Learn more about all of our groups.

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