Sample and Materials Management Technician - Quality Control

2024-07-08 | Lilly | Durham | North Carolina | United States

Perks & Benefits:

Location:
Durham, NC 27709

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.

The Sample and Materials Management Technician (SMM Tech) is responsible for overall sample and materials management activities supporting the QC laboratory. Such support includes collaborating with other site departments to facilitate sample coordination activities and working with laboratory personnel to ensure samples, reference standards and reagents within the laboratory are managed per procedural and regulatory requirements. The SMM Tech will also support daily laboratory readiness activities, such as performing daily instrument checks, as needed along with providing back up stability administrative support as needed.

Key Objectives/Deliverables:

  • Collaborate with other site departments via process team meetings and other scheduling tools, to coordinate sample delivery to the QC laboratory.
  • Receive samples in laboratory information management system (LIMS).
  • Review sample chain of custody and storage history.
  • Perform sample disposition and disposal.
  • Maintain automated sample management system (ASMS).
  • Maintain sample, reference standard and laboratory reagent inventory, ensuring physical inventory matches electronic inventory.
  • Lead sample submission process for samples sent from RTP to third party/external laboratories.
  • Lead sample receipt process for samples submitted to RTP from other Lilly sites.
  • Provide back up support to the stability administrative team, including stability sample pulls and stability sample management.
  • Respond to temperature excursions related to sample and material storage units.

Requirements (Education, Experience, Training):

  • High School Diploma, GED or Associates Degree in a Life Science, with a minimum of two years related experience.

Preferred attributes but not required:

  • Experience with electronic laboratory management systems (E.g., LIMS, LES, MODA, ELN).
  • Experience with Excel and Microsoft Office Suite.
  • Experience with TrackWise.
  • Experience with change control, analytical and deviation investigations, including root cause analysis and CAPA.
  • Experience with use and operation of analytical balances and pipettes.
  • Demonstrated problem solving and analytical thinking skills.
  • Understanding of statistical tools and trend analysis.
  • Excellent interpersonal skills and networking skills.
  • Strong organizational skills.
  • Experience in a GMP environment.
  • Demonstrated written and verbal communications skills.
  • Strong attention to detail.
  • May be required to provide on call support.
  • Demonstrated ability to work both independently and as a part of a Team.

Additional Information

  • 8-hour days – Monday through Friday.
  • May require support outside of regular schedule (weekend days or off-hours) in support of continuous (24/7) manufacturing operations.
  • Applicant will work in various areas within the site. Some allergens are present in the parenteral plant. Mobility requirements and exposure to allergens should be considered when applying for this position.
  • Tasks may require repetitive motion (E.g., keyboarding).
  • Minimal travel required.

This job specification 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 specification. As always, you should consult with your supervisor regarding your actual job responsibilities and any related duties that may be required for the position.

Eli Lilly and Company, Lilly USA, LLC and our wholly owned subsidiaries (collectively “Lilly”) are committed to help individuals with disabilities to participate in the workforce and ensure equal opportunity to compete for jobs. If you require an accommodation to submit a resume for positions at Lilly, please email Lilly Human Resources ( [email protected] ) for further assistance. Please note This email address is intended for use only to request an accommodation as part of the application process. 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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