Associate - QA Clinical Trial Packaging

BioSpace; Indianapolis (IN); On-site; USD 63,000 - 163,000; Full time

Job summary

A leading company in the pharmaceutical industry is seeking an Associate for QA Clinical Trial Packaging to provide quality oversight and ensure compliance with cGMP standards. This entry-level role offers the opportunity to work closely with packaging operations while supporting regulatory processes. The ideal candidate will possess a Bachelor's degree in a STEM field and at least 1 year of experience in pharmaceutical manufacturing, preferably with knowledge of cGMP regulations.

Benefits

Comprehensive benefits including 401k and health insurance

Company bonus program

Flexible spending accounts

Qualifications

• Minimum 1 year of experience in pharmaceutical manufacturing, ideally with CT packaging.
• Strong understanding of cGMPs and Quality Systems.

Responsibilities

• Ensure compliance with cGMP standards in packaging.
• Review/approve batch records and modify protocols as necessary.
• Assist during regulatory audits and maintain documentation integrity.

Skills

Attention to detail

Interpersonal skills

Time management

Communication

Education

Bachelor of Science degree in STEM

Tools

SAP

Job description

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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).

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, protocols and 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 1 year 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.
  
  
  

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 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.

Our employee resource groups (ERGs) offer strong support networks for their members and are open to all employees. Our current groups include: Africa, Middle East, Central Asia Network, Black Employees at Lilly, Chinese Culture Network, Japanese International Leadership Network (JILN), Lilly India Network, Organization of Latinx at Lilly (OLA), PRIDE (LGBTQ+ Allies), Veterans Leadership Network (VLN), Women’s Initiative for Leading at Lilly (WILL), enAble (for people with disabilities). Learn more about all of our groups.

Actual compensation will depend on a candidate’s education, experience, skills, and geographic location. The anticipated wage for this position is

$63,000 - $162,800

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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