Principal/Sr. Associate-QA-APIEM

Eli Lilly and Company • Indianapolis, IN

13d

About The Position

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 API EM Quality Assurance Consultant provides support to all quality activities at Contract Manufacturing organizations (CMs). The QA Consultant’s 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. Key Objectives/Deliverables: 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/APIEM Quality Plans Coordinate and perform QA responsibilities of API shipments from suppliers and CMs. Participate in regulatory inspection preparations with CMs. Provide on-site support during inspections. Participate on the Technical Review Board Evaluate and disposition API batches, 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 API manufacturing 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.

Requirements

• Bachelors degree in a science-related field such as Pharmacy, Chemistry, Biological Sciences or related Life Sciences.
• At least 2+ years previous GMP manufacturing experience in API or Pharma experience in finished product manufacturing, QC, QA or Engineering.
• Qualified applicants must be authorized to work in the United States on a full-time basis. Lilly will not provide support for or sponsor work authorization or visas for this role, including but not limited to F-1 CPT, F-1 OPT, F-1 STEM OPT, J-1, H-1B, TN, O-1, E-3, H-1B1, or L-1.

Nice To Haves

• 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.

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/APIEM Quality Plans
• Coordinate and perform QA responsibilities of API shipments from suppliers and CMs.
• Participate in regulatory inspection preparations with CMs.
• Provide on-site support during inspections.
• Participate on the Technical Review Board
• Evaluate and disposition API batches, 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 API manufacturing 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.

Benefits

• 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).

What This Job Offers

• Job Type: Full-time
• Career Level: Principal