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.

Actual compensation will depend on a candidate’s education, experience, skills, and geographic location.  The anticipated wage for this position is

$51,000 - $148,500

The Associate - Quality Assurance supports and provides guidance in deviation investigations, change control proposals, procedures and master formula revisions, validation, and batch disposition. The Associate-Quality Assurance position is essential for maintaining GMP compliance and in the preparation for pre-approval and general inspections by various regulatory agencies.

Job Responsibilities:

Support production: review/approve procedures and master formulas.Provide Quality Assurance oversight to GMP operations.Adhere to standard operating procedures and current Good Manufacturing Practices to ensure quality of product.Conduct analytical data review.Provide coaching and feedback to operational staff.Participate in and/or lead self-inspection activities.Performs batch disposition, audit trail reviews, review by exceptions including Delta V interventions.Maintain relationship with regulatory resourcesContribute to the achievement of key departmental objectives including safety performance, reducing deviations, and training compliance.Evaluates batch production records.Ensures documentation is created using good technical writing.Ensures that deviations are investigated and resolved in a timely manner.Serves as instructor of GMP and Quality related Standard Operating Procedures (SOP).Understand the Global Quality Standards (GQS) and Common Quality Practices (CQP) and how they apply to the Process Team operations.Educate the Process Team and operators on Global Quality Standards (GQS) and Common Quality Practices (CQP).Understand the science behind the process and equipment to facilitate science-based decision making.Know how upstream/downstream processing is affected by their process steps.Know the Operational Control Strategy and potential failure modes of the process.Know the historical deviations/gaps, trends, and audit history of the process.Perform classification, review and approval of observations and changes.Use statistical data to understand the sources of variability and to continuously improve the process.Review that practice matches procedure on the production floor.Ensure the Quality Systems complies with the Quality Standards.Serve as a liaison between the Process Team and other Quality areas (Laboratories, Compliance, Incoming, etc.).Review and approve deviations assuring robustness of Root Cause Analysis and effectiveness of Corrective Actions/Preventive Actions (CAPA). Assist in regulatory inspections.Escalate quality issues from manufacturing to the site-based process team.Notifies and escalate to quality management significant quality or compliance related issues.Provide visibility on metrics related to change controls and deviations and any other quality key performance indicator as needed.

Process Optimization & Continuous Improvement

Review, identify, and drive alignment of Quality Assurance systems across the supported operation.Review and identify opportunities for continuous improvement and Simplification and assist in prioritization of opportunities with respect to overall business objectives.Collaborate with key support groups around the development of process knowledge and a common process improvement agenda.Serve as liaison between Frontline Associate Quality and key Lilly affiliates quality personnel, Global Quality Unit during the consultation of Quality and Regulatory policies (e.g., Global Quality Standard (GQS), Lilly Quality Practices (LQP), Food and Drug Administration (FDA), and European Medicine Agency (EMA) Regulations).Serve as liaison between Quality Assurance and other functional areas that support the Process Team (e.g., Laboratories, Engineering, Supply Chain, Planning, Safety, CCI, Production, Automation, TS/MS, FUME)Benchmark Quality systems, process efficiency, and effectiveness.

 

Basic Requirements:

Bachelor's degree in Chemistry, Microbiology, Biotechnology or Science, preferred. PharmD professionals are encouraged to apply.Puerto Rico pharmacist license from the Department of Health (preferred).At least three (3) years of experience in Production, Quality Control, Quality Assurance, Technical Services, Regulatory is desirable.

Additional Skills/Preferences:

Knowledge of FDA cGMP’s and other regulatory requirementsFully bilingual (English/Spanish)Effective communication skills (both verbal and written)Technical Writing in English and Spanish.Good interpersonal and teamwork skillsOrganize and prioritize multi-functional tasksAttention to details and ability to identify improvement opportunities or discrepancies.Strong compliance mindset and sound judgementDemonstrated decision-making, problem-solving, organizational, and critical thinking techniques.Knowledge of pharma/biotechnology operations and related sciences.

Important Notice: In order to maintain the excellent reputation of our company, the quality of our products, and the safety of our working environment, the company will take all reasonable measures to ensure that drug abuse by employees or other persons does not jeopardize the safety of our operations or the quality of our products or adversely affect in any way the company or its employees. The company recognizes that drug use both on and off the job can be detrimental to the company and its efforts to provide a drug-free workplace. Even if prescribed under a state medical marijuana law, marijuana remains illegal under federal law. Marijuana is considered unauthorized by Lilly.

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 an EEO/Affirmative Action Employer and 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.

Our employee resource groups (ERGs) offer strong support networks for their members and help our company develop talented individuals for future leadership roles. Our current groups include: Africa, Middle East, Central Asia Network, African American Network, Chinese Culture Network, Early Career Professionals, Japanese International Leadership Network (JILN), Lilly India Network, Organization of Latinos at Lilly, PRIDE (LGBTQ + Allies), Veterans Leadership Network, Women’s Network, Working and Living with Disabilities. Learn more about all of our groups.

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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