Principal Associate - QA

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 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.
• 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

Benefits

Additional Information

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).

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