Quality Assurance Specialist–Manufacturing Compliance (2nd Shift)

Company Name: Eli Lilly and Company

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.

Organization Overview

At Lilly, we serve an extraordinary purpose. We make a difference for people around the globe by discovering, developing and delivering medicines that help them live longer, healthier, more active lives. Not only do we deliver breakthrough medications, but you also can count on us to develop creative solutions to support communities through philanthropy and volunteerism.

This position is responsible for second shift quality compliance support of manufacturing operations. This position will interact with the manufacturing, engineering, validation, quality control and regulatory departments. Interaction may be required with other Lilly site / contract producers of Lilly products.

The Quality Professional works within Lilly cross-functional groups, anticipates and resolves problems while driving solutions for processes and/or products. May lead small to large projects or programs with moderate risk. Manages quality-related matters specific to area of responsibility and provides on-the-floor support during second shift/off hours. Provides assistance to cross-functional groups with troubleshooting investigations and problem resolution. Assists with the implementation of change controls and/or reviews GMP documents associated with area of responsibility. Ensures area of responsibility remains inspection ready and may support regulatory/GMP inspections. Ensures observations associated with Lilly Branchburg are adequately addressed and completed on schedule. Represents Quality per Manufacturing Standard for Operational Excellence (MSOE) 602 within area of responsibility. Knowledge of cell culture, purification and support systems used in the manufacturing of biotech products is preferred.

Responsibilities:

• Main duties are to provide QA support during second shift/weekend timeframes when other QA is not available.
• Provide on-the-floor support, QA and GDP guidance, batch record review and comment resolution.
• Perform QA Walk throughs and data integrity reviews.
• Evaluate and process observations, trends or deviations to determine root cause(s) and assess quality impact. Recommend CAPA’s and ensure CAPAs implemented are effective.
• Evaluate change controls and associated risk assessments.
• Ensure sustainable compliance to all regulations related to area of oversight (e.g. 21 CFR Part 11 related to computer systems, data integrity associated with manual and electronic systems including review of audit trail information, etc).
• Review/approve SOP’s, Reports, Equipment/Method Qualifications/Verifications/Validations, Excursions, specifications and Work Orders for compliance to regulatory standards.
• Review/approve executed batch tickets and participate in API bulk release activities.
• Review/approve raw material specification packages, support material management at Branchburg site.
• Assist in creating quality metrics. Keep Quality Management informed of compliance issues.
• Assist with activities associated with technology transfers or product launches to and from Lilly Branchburg facilities.
• Attend and serve as a key resource in ad-hoc meetings to provide compliance guidance to Manufacturing, Laboratories, Maintenance, Validation or supporting business units.
• Ensure compliance with applicable Lilly global standards and regulatory guidelines.
• Serve as member on Process Team(s), continuous improvement, and general site support.
• Participate in Regulatory and partner inspections as necessary. Ensure timely follow up to any inspection findings.

Basic Qualification

• BA/BS in Chemistry, Biology, or a science-related field, or relevant work experience.

Additional Skills/Preferences

• Minimum of 1 year of experience in the pharmaceutical/biopharmaceutical industry.
• Previous technical experience should be related to area of responsibility, as appropriate. Preference for previous manufacturing, operations, or technical pharma experience.
• Must possess working knowledge of domestic and international GMP regulations and other policies/regulations as applicable.
• Possesses a conceptual understanding of all Quality functions and business areas.
• Must have the ability to function in a fast-paced environment and communicate effectively with management.
• Must be able to work in a cross-functional environment.
• Must be proficient in Microsoft applications.

Additional Information

• Shift schedule is Wednesday to Saturday, 2pm - 12am.

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 $69,000 - $179,300.

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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