Principal Associate
Healthcare
PrincipalAssociate-QA
Neural analysis suggests this role is
optimal for Mid candidates.
“Principal Associate - QA at Principal Associate. Skills: Quality Systems, cGMP compliance, Pharmaceutical manufacturing. Ensure execution of Quality Systems. Sustain cGMP compliance”
Industry & Context.
Ability to gather, edit, organize, and summarize information; good judgement in making decisions
Onsite presence the majority of the time
What They're Looking For.
Must Have
Bachelor of Science degree in STEM related field, or equivalent experience, Minimum 3-5 years of experience in pharmaceutical manufacturing
Nice to Have
CT packaging experience, knowledge of cGMPs, Quality Systems, 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, 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
What You'll Do.
Ensure execution of Quality Systems
Sustain cGMP compliance
Ensure document control
Ensure data integrity
Review/approve/release batch records
Create/verify Certificates of Analysis
Provide quality support
Investigate deviations
Review/approve change controls
Review/approve protocols
Review/approve master label proofs
Review/approve dating
Provide Quality oversight
Assist with regulatory audits
Assist with site self-inspections
Provide guidance to counterparts
How You'll Work.
Team & Collaboration
Work across functional areas with people of all levels of the organization; Influence team interactions
Communication Scope
oral and written communication skills
Full Job Description
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, 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 s
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