Principal Associate-QA API EM

Eli Lilly

  • Prince Edward Island
  • Permanent
  • Full-time
  • 1 day ago
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.Join the energetic and growing Active Pharmaceutical Ingredient - External Manufacturing Organization (API-EM) that delivers a diverse portfolio of medicines essential to our patients around the world. The PIP (person in plant) API EM Quality Assurance Associate will provide support to all quality activities within a dynamic external manufacturing environment. The PIP position is based in Prince Edward Island, Canada. The candidate must be within commuting distance.The QA Associate’s position is essential for ensuring that all batches meet specifications, are manufactured in accordance with the validated process, and are compliant with cGMPs and regulatory commitments. The QA Associate will need to interact daily with a wide variety of people, primarily external partners, team members, and site management.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.Provide quality oversight of Lilly/APIEM Quality PlansCoordinate and perform QA responsibilities of API shipments.Participate in regulatory inspection preparations with CMs.Provide on-site support during manufacturing events and inspections.Participate on the Technical Review BoardEvaluate 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, 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:Bachelor's of Science in a science-related field such as Pharmacy, Chemistry, Biological Sciences or related Life Sciences.Previous GMP manufacturing knowledge and/or experience in API or finished product manufacturing, QC, QA or Engineering.Additional Preferences:Experience in quality support for Drug Substance manufacturing activitiesThorough 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.Education Requirements:BS in a science-related field such as Pharmacy, Chemistry, Biological Sciences or related Life Sciences.Other Information:Must complete required training for API EM Quality Assurance.No certifications required.Required onsite 3 days a week and must be able to support 24 hour/day operations.Some travel (
25%) is required primarily to Indianapolis, IndianaThe job specification is intended to provide a general overview of the job requirements at the time it was prepared. The job requirements of any position may change over time and may include additional responsibilities not specifically described in the job specification. As always, you should consult with your supervision regarding your actual job responsibilities and any related duties that may be required for the position.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 ( ) 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 does not discriminate on the basis of age, race, color, religion, gender, sexual orientation, gender identity, gender expression, national origin, protected veteran status, disability or any other legally protected status.#WeAreLilly

Eli Lilly