QA Dry External Manufacturing (Drug product & Packaging) Associate

Eli Lilly and; Indianapolis (IN); On-site; USD 65,000 - 170,000; Full time

Job summary

A global healthcare leader in Indianapolis is seeking a Dry EM Quality Assurance Representative to provide quality oversight at Contract Manufacturing organizations. The ideal candidate holds a BS in a science-related field and has over 3 years of GMP manufacturing experience. Responsibilities include ensuring compliance with quality agreements and coordinating QA activities. The role requires excellent communication and attention to detail, as well as proficiency in quality systems and regulatory requirements.

Benefits

Comprehensive benefit program

401(k) and pension eligibility

Flexible spending accounts

Well-being benefits

Qualifications

• 3+ years previous GMP manufacturing knowledge and/or experience in API/intermediates or finished product manufacturing, QC, QA or Engineering.

Responsibilities

• Serve as a liaison between CMs and Lilly.
• Provide quality oversight of CMs including being the initial point of contact for all quality-related issues.
• Ensure compliance to Quality Agreements and Manufacturing Responsibilities Documents (MRDs).
• Provide quality oversight of Lilly/Dry-EM Quality Plans.

Skills

Attention to detail

Communication skills

Organizational skills

Statistical skills

Coaching and mentoring

Education

BS in a science-related field

Tools

Quality systems applications

Job description

Overview

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.

The Dry EM Quality Assurance Representative provides support to all quality activities at Contract Manufacturing organizations (CMs) related to the manufacturing process of bulk dry products (tablets/capsules) and packaging. The QA Representative position is essential for ensuring that all batches meet specifications, are manufactured in accordance with the validated process and are compliant to cGMPs and regulatory commitments.

Responsibilities

• Serve as a liaison between CMs and Lilly.
• Provide quality oversight of CMs including being the initial point of contact for all quality-related issues.
• Escalate quality issues at CMs to Lilly QA management.
• Assist in the establishment and revisions of Quality Agreements with affiliates and customers.
• Ensure compliance to Quality Agreements and Manufacturing Responsibilities Documents (MRDs).
• Provide quality oversight of Lilly/Dry-EM Quality Plans
• Coordinate and perform QA responsibilities of Bulk/finished product shipments.
• Participate in regulatory inspection preparations with CMs. Provide on-site support during inspections.
• Participate on the Technical Review Board
• Evaluate and disposition batches of bulk and finished product, if required.
• Ensure that documented checks have been completed for the Certificates of Testing and Certificates of Environmental Monitoring (where applicable), and deviations, changes and batch documentation that demonstrates requirements have been met prior to batch release.
• Provide quality support of the manufacturing process for bulk (capsules and tablets) and packaged products with the focus on holistic review of key activities associated with or impacting the manufacturing processes including deviations, change controls and countermeasures.
• Assess the impact of deviation investigations and changes and ensure that all appropriate records are documented and retrievable.
• Ensure all processes are in an appropriate state of control.
• Maintain awareness of external regulatory agency findings which individually or collectively reference the quality of the product.
• Review and approve documents including, but not limited to, procedures, master production records, change control proposals, deviations, equipment qualifications, analytical methods and computerized system validations.
• Participate in APR activities.
• Participate in projects to improve productivity.
• Participate in Joint Process (JPT) and Post Launch Optimization (PLOT) Teams.

Basic Requirements

• BS in a science-related field such as Pharmacy, Chemistry, Biological Sciences or related Life Sciences.
• 3+ years previous GMP manufacturing knowledge and/or experience in API/intermediates or finished product manufacturing, QC, QA or Engineering.

Additional Preferences

• Experience in quality support for Quality Control activities
• Thorough technical understanding of quality systems and regulatory requirements.
• Knowledge of pharmaceutical manufacturing operations.
• Demonstrated coaching and mentoring skills.
• Experience in root cause analysis.
• Demonstrated application of statistical skills.
• Demonstrated strong written and verbal communications skills.
• Strong attention to detail.
• Proficiency with computer system applications.
• Excellent interpersonal skills and networking skills.
• Ability to organize and prioritize multiple tasks.
• Ability to influence diverse groups and manage relationships.

Other Information

• Must complete required training for Dry-EM Quality Assurance.
• No certifications required.
• Must be able to support 24 hour/day operations.
• Willingness to travel, expected 30% travelling.

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 $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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