Scientist, QA - #442330

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.

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.

Position Summary

Reporting into the Senior Manager of Quality Assurance the Scientist, QA will be responsible for:

• Supporting the organization with continued compliance and monitoring conformance to established internal procedures and regulatory standards.
• Batch record review and final batch release.
• Supplier qualification.
• Managing quality events and the associated investigations at the site.
  
  
  

Responsibilities

• Reviewing batch records, product specifications, Certificates of Analysis and all other supporting documentation related to the release of product.
• Involved in vendor qualification.
• Quality oversight of the Change Control system.
• Initiate CAPAs and Change Controls as applicable.
• Manage notification to stakeholders and timely completion of Key Performance Indicators (KPI)
• Review and evaluate compendia monograph updates and regulatory guidance updates.
• Participate as member of site deviation investigation teams.
• Write and assist others in writing Standard Operating Procedures (SOPs) and manage the approved SOPs.
• Issue documents and logbooks as required.
• Perform material release
• Assist in Vendor Quality Agreements
• Support site training program.
• Assist in Annual GMP Training.
• May perform other related additional duties as assigned.
  
  
  

Basic Requirements

• B.Sc in the life sciences degree; including pharmacy, chemistry or other equivalent qualification
• Minimum 3 years working in the pharmaceutical manufacturing industry.
• Understanding of Health Canada, FDA and EU GMP regulations, with specific knowledge of the regulations as they pertain to sterile products preferred.
• The position will observe typical business hours, Monday through Friday. Minimal early or late hours are required on occasion.
  
  
  

Additional Preferences

• Demonstrated knowledge in Microsoft Office (including Outlook, Word, Excel, and PowerPoint).
• Operate and execute with a high sense of urgency.
  
  
  

Physical Demands/Travel

The physical demands of this job are consistent with a lab environment.

The physical demands here are representative of those that must be met by an employee to successfully perform the essential functions of this job.

Work Environment

This position’s work environment is in a Laboratory.

The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job.

• To perform this job successfully, an individual must be able to perform the role and responsibilities satisfactorily. The requirements listed above are representative of the knowledge, skill, and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
  
  
  

Lilly is dedicated to helping individuals with disabilities to actively engage in the workforce, ensuring equal opportunities when vying for positions. If you require accommodation to submit a resume for a position at Lilly, please complete the accommodation request form (https://careers.lilly.com/us/en/workplace-accommodation) for further assistance. Please note this is for individuals to request an accommodation as part of the application process and any other correspondence will not receive a response.

Lilly 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.

#WeAreLilly