Advisor-Quality Control
Eli Lilly
- Indianapolis, IN
- Permanent
- Full-time
- Serve as an analytical resource and mentor for scientists, managers, and other disciplines.
- Influence and manage the QC technical support for non-routine (e.g., deviations, changes, complaint) investigations, including consultation on quality and stability issues with the API EM network of contract partners.
- Review, author and/or approve relevant technical documents, such as change controls, regulatory submissions, expert opinions, deviations, validations, procedures, APRs, PFDs, etc. as applicable.
- Manage QC experimental projects to improve method performance robustness, and overall analytical control strategies for the API EM portfolio.
- Support identification and development of new analytical technologies into internal API EM laboratories and subsequent implementation for the improvement of existing analytical control strategies.
- Own the QC technical agenda for the API EM portfolio, including maintaining a technical understanding of the regulations applicable to laboratory testing in a cGMP environment.
- Identify and resolve laboratory safety issues within the API EM laboratories.
- Bachelor’s degree in a scientific field related to the laboratory, such as Chemistry, Biological Sciences or related a Life Sciences field.
- Minimum of five years of prior laboratory experience
- Advanced degree in a scientific field related to the laboratory, such as Chemistry, Biological Sciences or related a Life Sciences field
- Demonstrated technical knowledge in laboratory analytical techniques, including, but not limited to, chromatographic, spectroscopic, and/or microbiological assays.
- Thorough technical understanding of compliance requirements and regulatory expectations.
- Demonstrated strong problem-solving skills.
- Strong oral and written communication skills.
- Demonstrated strong interpersonal interaction skills, with a proven ability to influence diverse groups and manage relationships.
- Demonstrated technical leadership skills (decision making, prioritization, mentoring, conflict resolution).
- Demonstrated coaching and mentoring skills
- Demonstrated skills in root cause analysis and application of statistical skills.
- Demonstrated flexibility when faced with changing priorities
- Strong attention to detail
- Strong self-motivation