Technician – QC – IAPI

Lilly•Indianapolis, IN

10d•Onsite

About The Position

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.

Requirements

High School Diploma (or equivalent)
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.
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 and visas for this role.

Nice To Haves

3 years+ of relevant experience
Associate’s degree
Proficiency with computer systems, including Microsoft Office products, LIMS, etc.
On-call and holiday coverage may be needed
Tech will support Micro and EM testing

Responsibilities

Ensure work is completed in a timely manner to meet sample TAT (Turnaround Time) and site priorities.
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.
Execute activities in compliance with applicable standard operating procedures (SOPs), methods/protocols, good documentation practices (GDP), and regulatory guidelines.
Execute activities in accordance with data integrity standards and ALCOA+ principles.
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.
Identify and communicate opportunities for improvement as well as supporting those implementations.
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.
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
Handle samples in accordance with local procedures to prevent contamination.
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.
Accurately and safely perform microbiological testing in accordance with established laboratory procedures and GMP requirements.
Label samples and document sample collection in accordance with local procedures.
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.
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.
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.