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Sr. Associate-QA Operations (Batch Release)

Employer
Eli Lilly and Company
Location
Branchburg, New Jersey
Start date
Nov 13, 2023

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Job Details

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.

Lilly employees 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 in order to deliver a reliable supply of medicine for people around the world.

Position Brand Description: 

Release commercial and clinical cell banks, drug substance drug product, finished goods and raw materials.  This person must apply strategic-thinking and forward planning to ensure inventory demands are met, drives solutions for continuous improvement of quality lot release programs.  Additionally, they must build collaborative working relationships with internal and external partners and remove barriers to ensure a reliable supply of medicines.  Work closely with Regulatory partners to ensure right product / right country. This person must ensure on time lot release and apprise Quality Management of issues delaying or preventing release.  Interact with the FDA and other regulatory agencies as required.

Key Objectives/Deliverables: 

Manage for Results /Strategic Planning: 

  • Disposition commercial and clinical API lots and raw materials.
  • Work closely with the business and quality representatives to write and/or ensure deviations and changes are approved in support of lot release.
  • Work closely with partners and CMOs to assure timely review/release of API.
  • Attend and serve as a key resource in ad-hoc meetings to provide guidance on batch priorities for release and issues preventing release.
  • Serve as core representative at cross-functional meetings related to batch disposition.
  • Identify and implement measures to streamline release process.
  • Provide support during Regulatory inspections and audits conducted by internal and external partners.
  • Track and trend release activities through reporting metrics.  Escalate any time delays in advance to Senior Quality Management.

Manage Relationships with Key Stakeholders and Customers: 

  • Communicate with business partners in routine forums on batch release status.

Basic Requirements: 

  • BS/BA degree in the sciences preferred with a minimum of 3-5 years’ experience in the pharmaceutical or biotechnology industry. (Would consider candidates with their Associates or HS diploma with relevant technical experience)
  • Must have prior product disposition experience; TrackWise and SAP experience preferred.

Additional Preferences:

  • Sound knowledge of domestic and international regulations policies and guidelines for pharmaceutical and/or biotechnology products.
  • Possesses a conceptual understanding of all Quality Systems functions and business areas.
  • Able to make decisions guided by policies, procedures and business plan that impacts the efficiency and effectiveness of own work unit.
  • Influence peers, internal and external customers.
  • Identify and solve day-to-day operational and technical problems; confers with direct manager to address more complex issues.
  • Works within budgetary and financial objectives set by management.
  • Experience working with electronic systems such as SAP, TrackWise, LIMS and Quality Docs (Veeva).
  • Must be a self-starter, highly motivated, highly organized, detail oriented and possess effective written and verbal communication skills.
  • Support training of new Quality representatives. Mentor less experienced quality professionals.
  • Identify/support solutions to increasing workload/changing priorities situations.
  • Review new/revised departmental SOPs, Forms, and Checklists.
  • Assist in the approval of official documentation.
  • Support Regulatory Filings, on-site and virtual inspections.

Other Information:

  • Travel may be required.
  • Lifting not required.
  • Required to be on call.

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.

#WeAreLilly

Company

Science has been our calling from the beginning. Colonel Eli Lilly founded the company in 1876 and charged employees to “take what you find here and make it better and better.” More than 147 years later, we remain committed to his vision through every aspect of our business and the people we serve, starting with discovering the best treatments for those who take our medicines and extending to health care professionals, employees and the communities in which we live. Moreover, you can also count on the team at Lilly to be incredibly civic-minded, supporting our communities through philanthropy, volunteerism, and a creative and innovative can-do spirit. 

Company info
Location
893 S Delaware St
Indianapolis
Indiana
46285
United States

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