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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.
Supervisor: Sr. Manager - QC - IAPI
Position Title: Technician - QC - IAPI
Position Type: Full Time
Job Level: B1-B3-2
Location: LTC-S Indianapolis
Job Function: Quality Control
Tech Ladder Approved: No
Position Brand Description:
The Technician - QC - IAPI performs accurate, timely testing of routine lab samples in accordance with applicable GMP and safety guidelines. The Technician - QC -IAPI identifies and communicates opportunities for improvement within the lab.
Key Objectives/Deliverables:
- Timeliness: Ensure work is completed in a timely manner to meet sample TAT (Turnaround Time) and site priorities.
- Safety and GMP Compliance: Adhere to Environmental Health and Safety (EHS) requirements and laboratory safety procedures. Maintain cleanliness and contamination control, in alignment with cGMPs, chemical hygiene, and biosafety guidelines.
- Compliance and Documentation: Execute activities in compliance with applicable standard operating procedures (SOPs), methods/protocols, good documentation practices (GDP), and regulatory guidelines.
- Data Recording and Data Integrity: Execute activities in accordance with data integrity standards and ALCOA+ principles.
- Deviation Identification and Investigation: Identify and escalate any atypical results and potential deviations. Communicate with QC Microbiology Team. Share context regarding non-routine samples and ensure analysts are aware of time sensitive samples.
- Continuous Improvement: Identify and communicate opportunities for improvement as well as supporting those implementations.
- Cross-functional Participation: Participate in cross-functional teams (e.g., process team, global working teams, etc.), as required. Communicate clearly with Operations and work together to ensure samples are collected in accordance with the approved sampling plan. Inform Operations and QC promptly if samples cannot be collected per plan.
-Audit and Inspection Support: Execute activities in a compliant manner that supports an ongoing state of inspection readiness. Participate in pre-inspection reviews/checks and provide on-site support during audit/inspections, as requested
-Sample Handling: Handle samples in accordance with local procedures to prevent contamination.
-Sampling: Collect environmental samples in manufacturing areas in accordance with established procedures and schedules. Sampling may include operating viable air samplers, surface contact plates, settle plates, and non-viable particulate counters to collect samples of air, surfaces, and gowning.
-Microbiological Testing: Accurately and safely perform microbiological testing in accordance with established laboratory procedures and GMP requirements.
Sample Collection and Labeling: Label samples and document sample collection in accordance with local procedures.
Comply with Aseptic Practices: Follow aseptic technique during sampling activities, as required, in accordance with local procedures. Samplers may be required to aseptically gown in accordance with the area gowning requirements for classified areas.
Equipment Preparation: Perform pre-use and post-use cleaning of sampling equipment (e.g. sanitize air samplers and particle counters) and coordinate required calibration or maintenance with the QC equipment team.
Equipment Use: Perform routine checks (e.g. calibration verification for balances) in accordance with established methods/procedures. Immediately report equipment malfunctions or out-of-tolerance conditions. Assist with basic troubleshooting of analytical methods and laboratory issues. Escalate persistent or complex issues and provide clear information to enable issue resolution while minimizing downtime and gaining knowledge for future troubleshooting.
Education Requirements:
-High School Diploma (or equivalent)
Basic Requirements:
- Ability to work in a lab environment and Environmental Areas, including wearing appropriate PPE and other safety equipment and considerations.
- Ability to work in a highly regulated environment.
- Demonstrated strong math and documentation skills.
- Demonstrated strong oral and written communication and interpersonal interaction skills.
-Must be able to lift at least 5 liters of liquid and carry equipment up flights of stairs.
-Tasks may require repetitive motion and standing for long periods of time.
- Sponsorship: Qualified applicants must be authorized to work in the United States on a full-time basis. Lilly will not provide support for or sponsor work authorization or visas for this role, including but not limited to F-1 CPT, F-1 OPT, F-1 STEM OPT, J-1, H-1B, TN, O-1, E-3, H-1B1, or L-1.
Additional Preferences:
-3 years+ of relevant experience
-Associate's degree
-Proficiency with computer systems, including Microsoft Office products, LIMS, etc.
Other Information:
-Must complete applicable Learning Plan for a Technician - QC - IAPI.
-Schedule M-F Nights
-Tech will support Micro and EM testing
-On-call and holiday coverage may be needed
The 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.
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 is proud to be an EEO Employer and does not discriminate on the basis of age, race, color, religion, gender identity, sex, gender expression, sexual orientation, genetic information, ancestry, 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 are open to all employees. Our current groups include: Africa, Middle East, Central Asia Network, Black Employees at Lilly, Chinese Culture Network, Japanese International Leadership Network (JILN), Lilly India Network, Organization of Latinx at Lilly (OLA), PRIDE (LGBTQ+ Allies), Veterans Leadership Network (VLN), Women's Initiative for Leading at Lilly (WILL), enAble (for people with disabilities). Learn more about all of our groups.
Actual compensation will depend on a candidate's education, experience, skills, and geographic location. The anticipated wage for this position is
$18.02 - $34.90
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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