Senior Associate, Quality Assurance – Incoming Batch Disposition

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.

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.

Position Overview:

Lilly is actively growing its manufacturing footprint globally to meet the needs of patients and deliver on our exciting future.  As a result, Lilly is looking for experienced quality assurance associates to support our growth in Alzey, Germany. This is an outstanding opportunity to deliver on new manufacturing investments and new pioneering technologies.

The Senior Associate, Quality Assurance – Incoming Batch Disposition has primary responsibility for release of incoming materials utilizing SAP and Lab systems. This includes materials such as active pharmaceutical ingredients, components, and excipients. The QA Batch Disposition Representative advises on issues such as non-conformance investigations, change control proposals, and procedures related to the incoming batch disposition process. The QA Batch Disposition Representative also provides guidance to process team members for batch related issues, such as non-conformance investigations, issue resolution, and other batch disposition activities.

Responsibilities:

• Maintains responsibility for a safe work environment, leading safety initiatives, and working safely; accountable for supporting all Health, Safety, and Environmental Corporate and Site Goals.
• Performs batch disposition of incoming materials, including active pharmaceutical ingredients, components, and excipients to ensure availability of approved supply to support operations.
• Leads, mentors and coaches Operations and support personnel on quality matters associated with incoming materials including the batch disposition process.
• Provides guidance in operational areas to ensure robust Quality Systems and GMP compliance.
• Participates in self-led inspections and/or provides support during internal/external regulatory inspections.
• Initiates, reviews, and/or approves GMP documents to ensure quality attributes are met (e.g., deviations, procedures, protocols, specifications, change controls).
• Participates in continuous improvement initiatives to improve productivity within the Batch Disposition work center and/or the site.

Basic Requirements:

• Bachelor's degree in a science, engineering, or pharmaceutical-related field of study or equivalent experience.
• Minimum 5 years in the pharmaceutical industry with specific batch disposition experience.
• Fluent in English and German.
• On-site presence required.

Additional Skills/Preferences:

• Demonstrated understanding of cGMP regulations.
• Previous experience in GMP production environments.
• Experience in inventory management systems (e.g., EWM, SAP).
• Demonstrated relevant experience in a GMP facility.
• Proficiency with applicable computer systems (e.g., Trackwise, Veeva, PharmaSuite).
• Demonstrated strong oral and written communication skills.
• Demonstrated interpersonal skills and the ability to work as a team.
• Root cause analysis/troubleshooting skills.
• Demonstrated attention to detail and ability to maintain quality systems.
• Proven ability to work independently or as part of a Team to resolve an issue.
• Technical Writing and Communication Skills.
• Previous regulatory inspection readiness and inspection execution experience.

Additional Information:

• Primary location is Alzey, Germany
• Ability to travel (approximately 10%)
• Ability to work overtime as required

This job description 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 description. For GMP purposes, the job description should be updated for significant changes.  As always, you should consult with your supervisor 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 (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 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.

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