Principal/Sr. Associate-QA-API External Manufacturing

Eli Lilly and Company; Indianapolis (IN); On-site; USD 65,000 - 169,000; Full time

Benefits offered by this job

Company bonus

401(k) plan

Medical, dental, vision benefits

Paid time off

Job summary

Eli Lilly and Company in Indianapolis invites a QA-focused professional to join our API/Pharma Quality Assurance team. You will serve as a liaison between CMs and Lilly, oversee quality for shipments, and escalate issues to Lilly QA management for timely resolution.

Responsibilities include ensuring compliance with quality agreements, reviewing master records and validation documents, and supporting regulatory inspections. Requires GMP experience and US work authorization.

Qualifications

• Bachelor's degree in a science-related field (Pharmacy/ Chemistry/ Biological Sciences or related Life Sciences).
• At least 2 years GMP manufacturing experience in API or Pharmaceutical finished product, QC, QA or Engineering.
• Authorized to work in the United States full-time; Lilly does not sponsor work authorization or visas.
• Experience in quality support for QC activities
• Thorough 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

Responsibilities

• Serve as liaison between CMs and Lilly and provide quality oversight.
• Escalate quality issues at CMs to Lilly QA management and assist in Quality Agreements.
• Ensure compliance to Quality Agreements and MRDs and review documents for batch release.
• Coordinate QA responsibilities of API shipments from suppliers and CMs; participate in inspections.
• Review documents including procedures, master production records, deviations, changes and validations.
• Participate in APR, productivity projects, JPT and PLOT teams.

Skills

GMP manufacturing experience

Quality systems knowledge

Regulatory compliance understanding

Coaching and mentoring skills

Root cause analysis

Statistical skills

Education

Bachelor's degree in science-related field

Job description

At Lilly, the work is demanding because patients are waiting. We unite caring with discovery to help make life better for people around the world, knowing that every decision, every detail, and every day matters. Headquartered in Indianapolis, Indiana, our over 50,000 employees around the globe take on complex challenges to discover and deliver life-changing medicines, strengthen how health is understood and managed, and support the communities we serve. This is hard, urgent, selfless work—but it’s work worth doing. If you’re driven by purpose and ready to bring your best to work that truly matters for patients, we invite you to join us.

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.

Basic 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.

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.

  Other Information

  • Must complete required training for API EM Quality Assurance.
  • No certifications required.
  • Must be able to support 24-hour/day operations.
  • Continental and Intercontinental travel may occur (~20%)

  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 (AMECA), Black Employees at Lilly (BE@Lilly), Chinese Culture Network (CCN), EnAble, Evolve, Lilly Indian Network (LIN), Organization of Latinx at Lilly (OLA), Pride (LGBTQ+ Allies), Veterans Leadership Network (VLN) and Women's Initiative for Leading at Lilly (WILL).

  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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