Associate - Parenteral Drug Product QA

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.

Responsibilities: The PD Drug Product QA Associate collaborates across functions to support the establishment of a new CT DP filling facility. Duties include providing quality support for the production of sterile CT parenteral drug products review as well as support of commissioning and qualification activities for a new manufacturing line or expanded capabilities of existing manufacturing line(s).

Additional responsibilities include, but are not limited to:

CT Parenteral Drug Product Production:

• 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.

Facility Delivery:

• Collaborate with QA Engineering to develop and support C&Q testing strategies in alignment with current Good Manufacturing Practices (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.

Basic Requirements:

• Bachelor's degree required (science-related field preferred; pharmacy, engineering, biology, chemistry, etc.).
• Relevant work experience in a parenteral filling facility may substitute for the science-related degree.

Additional Skills/Preferences:

• 2+ years' cumulative experience in commercial or development manufacturing in a cGMP environment, preferably in quality assurance.
• Experience with sterile manufacturing or facility installation in QA, operations, technical services, or engineering.
• 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.

Additional Information: Occasional domestic or international travel (<10%) may be required for visits to equipment vendors, design firms, benchmarking sites, or conferences. The position will support manufacturing activities in Indianapolis (LTCN).

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

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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