Chemist-QC-IAPI-Bulk Testing Lab

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Job description

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 Brand Description:

The Chemist - QC - IAPI in the Bulk testing lab performs accurate and timely testing of routine lab samples in accordance with appropriate GMP and safety guidelines. The Chemist - QC - IAPI also participates in second person verification (SPV) of analytical data, laboratory investigations, equipment calibrations and maintenance by executing well-defined protocols and procedures. The Chemist - QC - IAPI identifies and communicates opportunities for improvement within the lab.

The Chemist - QC - IAPI reviews and interprets results for their laboratory. The Chemist - QC - IAPI initiates analytical method re-evaluations based on data generated within the laboratory including knowledge acquired from monitoring the Proven Important Factors (PIFs) monitored within the laboratory data. They may perform non-routine laboratory work in support of those projects.

The Chemist - QC - IAPI utilizes technical skills to perform in-depth problem solving, proactively identify opportunities for continuous improvement, and complete thorough investigations of atypical data and results. Outcomes of these activities including results, conclusions, and action plans and/or technical documents.

Responsibilities:

The position is responsible for technical mentoring of laboratory staff and sharing technical information and best practices within the work group and across plant sites. The Chemist - QC - IAPI participates and influences the technical agenda of the plant or corporation.

Sample Analysis and Reporting

• Accurately and safely perform analytical test methods or related support activities as per procedures or protocols and reviews that results conform to standards
• Perform data entry and reviews own work for accuracy in accordance with laboratory procedures, standards, and GMP requirements
• Recognizes when a deviation from procedures, etc. has occurred and initiates an investigation
• Verify (SPV) analytical data of other analysts within the lab as required

Continuous Improvement Initiatives

• Identifies and communicates opportunities for improvement initiatives in daily work activities
• Troubleshoot equipment and methods as required

Lab Operations

• Training and mentoring others within lab, where applicable
• Executes notification to management when required by procedures or standards
• Understand the scientific principles required for manufacturing and testing of intermediates and bulk drug substances, including the interaction of the chemistry and equipment.
• Develop, monitor, and appropriately react to established statistically based metrics in real-time to assess analytical vs. process variability and capability.
• Provide technical support to non-routine (e.g., deviation) investigations
• Support production floor operations through change proposals, investigations, and deviation root cause analysis.
• Maintain and improve quality systems including method remediation.
• Participate in self-assessments and regulatory agency inspections.
• Ensure internal and external quality and supply commitments are met.

Basic Qualifications:

• Bachelor degree in a science related field
• Experience and knowledge of cGMP requirements

Additional Preferences:

• Demonstrated strong problem solving and analytical thinking skills
• Understanding of statistical tools and analysis
• Excellent interpersonal skills and networking skills
• Experience in QA, QC, Manufacturing, Tech Services, or Regulatory Affairs
• Demonstrated strong written and verbal communications skills
• Strong attention to detail
• Ability to organize and prioritize multiple tasks

Additional Information:

• Must complete applicable Learning Plan
• Tasks require entering manufacturing and laboratory areas which require wearing appropriate PPE
• May be required to provide on call support

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 ( ) 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.

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