Associate - Parenteral Drug Product QA

Role Summary

Associate - Parenteral Drug Product QA. The role supports quality assurance for a CT parenteral drug product filling facility, providing quality support for sterile CT parenteral drug product production and supporting commissioning and qualification activities for a new manufacturing line or expanded capabilities. This role collaborates across functions to ensure compliance with regulatory standards and cGMPs, supports internal capability development, and will be based in Indianapolis, Indiana (LTCN).

Responsibilities

• Oversee execution of quality systems to ensure ongoing compliance with regulatory standards and cGMPs.
• Take part in daily activities and decision-making, including deviations and change controls.
• Assess the impact of changes and deviations on product and regulatory commitments.
• Identify opportunities for continuous improvement in productivity and compliance.
• Review GMP documents, including batch records and logbooks.
• Qualify in visual inspection and execute related statistical sorting tasks.
• Advise cross-functional teams to maintain and improve quality systems.
• Provide support during internal and regulatory site inspections.
• Collaborate with the drug product organization supporting CT manufacturing to support internal capability development.
• Report concerns or issues to QA and business management as needed.
• Collaborate with QA Engineering to develop and support C&Q testing strategies in alignment with cGMP and quality system requirements.
• Participate in project sub-teams.
• Coordinate with functional areas such as Sterility Assurance, Technical Services, and Engineering to establish operational procedures.
• Develop and/or influence training materials related to aseptic manufacturing and cGMPs.

Qualifications

• Required: 1 year of experience with sterile manufacturing or facility installation in QA, operations, technical services, or engineering.
• Required: 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.

Skills

• Bachelor's degree in science-related field: pharmacy, engineering, biology, chemistry, preferred
• 2+ years' cumulative experience in commercial or development manufacturing in a cGMP environment, preferably in quality assurance.
• Ability to work independently and manage multiple priorities.
• Skills in team leadership, problem solving, risk-based decision making, and learning agility.
• Ability to promote and model a quality culture.
• Root cause analysis and troubleshooting capabilities.
• Strong written and oral communication skills.
• Interpersonal skills for team-based environments.
• Experience with process improvement initiatives.

Education

• Bachelor's degree required.

Additional Requirements

• Occasional domestic or international travel (<10%) may be required for visits to equipment vendors, design firms, benchmarking sites, or conferences.