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Principal Associate - QAInitial Therapeutics, Inc. • Indianapolis, Indiana, United States
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Principal Associate - QA

Initial Therapeutics, Inc.
  • US
    Indianapolis, Indiana, United States
  • US
    Indianapolis, Indiana, United States
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About

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.
Product Research and Development (PRD) Quality Assurance (QA) is responsible for providing quality oversight of all materials used in clinical trials. PRD QA CT Packaging is responsible for oversight of packaging and release of finished goods material within PRD and assures compliance with quality systems and current Good Manufacturing Practices (cGMP).
Key Responsibilities
Ensure appropriate execution of the Quality Systems to sustain cGMP compliance.
Ensure adequate document control and data integrity for packaging instructions and cGMP standards.
Review/approve/release batch records.
Create/verify Certificates of Analysis.
Provide quality support for packaging operation.
Investigate, review/approve deviation investigations.
Review/approve change controls, protocolsand master label proofs.
Review/approve allowable dating, stability justifications and retest dating for clinical trial (CT) Materials.
Provide Quality oversight for Collaboration Partners as needed.
Assist with regulatory body audits and site self-inspections to ensure cGMP compliance.
Provide guidance to counterparts within organization.
Basic Requirements
Bachelor of Science degree in STEM related field, or equivalent experience
Minimum 3-5 years of experience in pharmaceutical manufacturing (CT packaging experience preferred)
Additional Preferences
Strong knowledge of cGMPs, Quality Systems and FDA Regulations
SAP Power user experience
Standard Operating Procedure writer experience.
Ability to work across functional areas with people of all levels of the organization.
Strong oral and written communication skills.
Demonstrated interpersonal and networking skills.
Ability to gather, edit, organize, and summarize information from multiple sources including databases, websites, site interviews and audits.
Ability to influence team interactions and lead initiatives.
Must exhibit attention to detail.
Ability to work under time pressure with proven demonstration of good judgement in making decisions under minimal supervision.
Excellent teamwork skills
Other information
This position is onsite based in Indianapolis, IN. It will require onsite presence the majority of the time.
We are 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 is proud to be an EEO Employer and does not discriminate on the basis of age, race, color, religion, gender identity, sex, gender expression, sexual orientation, genetic information, ancestry, national origin, protected veteran status, disability, or any other legally protected status.
Actual compensation will depend on a candidate’s education, experience, skills, and geographic location. The anticipated wage for this position is
$65,250 - $169,400
Full-time equivalent employees also will be eligible for a company bonus (depending, in part, on company and individual performance). In addition, Lilly offers a comprehensive benefit program to eligible employees, including eligibility to participate in a company-sponsored 401(k); pension; vacation benefits; eligibility for medical, dental, vision and prescription drug benefits; flexible benefits (e.g., healthcare and/or dependent day care flexible spending accounts); life insurance and death benefits; certain time off and leave of absence benefits; and well-being benefits (e.g., employee assistance program, fitness benefits, and employee clubs and activities). Lilly reserves the right to amend, modify, or terminate its compensation and benefit programs in its sole discretion and Lilly’s compensation practices and guidelines will apply regarding the details of any promotion or transfer of Lilly employees.
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  • Indianapolis, Indiana, United States

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  • English
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