Technician - QC - IAPI

Eli Lilly and Company • Us, IN

5d • 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. 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 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. - In Process Testing: Accurately and safely perform QC 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. 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.

Requirements

• High School Diploma (or equivalent)
• Ability to work in a lab environment, 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 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.

Nice To Haves

• 3 years+ of relevant experience
• Associate’s degree
• Proficiency with computer systems, including Microsoft Office products, LIMS, etc.
• Proficiency with HPLC, UPLC, GC, and Karl Fischer

Responsibilities

• Performs accurate, timely testing of routine lab samples in accordance with applicable GMP and safety guidelines.
• Identifies and communicates opportunities for improvement within the lab.
• Ensures work is completed in a timely manner to meet sample TAT (Turnaround Time) and site priorities.
• Adheres to Environmental Health and Safety (EHS) requirements and laboratory safety procedures.
• Maintains cleanliness and contamination control, in alignment with cGMPs, chemical hygiene, and biosafety guidelines.
• Executes activities in compliance with applicable standard operating procedures (SOPs), methods/protocols, good documentation practices (GDP), and regulatory guidelines.
• Executes activities in accordance with data integrity standards and ALCOA+ principles.
• Identifies and escalates any atypical results and potential deviations.
• Communicates with QC Team.
• Shares context regarding non-routine samples and ensures analysts are aware of time sensitive samples.
• Identifies and communicates opportunities for improvement as well as supporting those implementations.
• Participates in cross-functional teams (e.g., process team, global working teams, etc.), as required.
• Communicates clearly with Operations and works together to ensure samples are collected in accordance with the approved sampling plan.
• Informs Operations and QC promptly if samples cannot be collected per plan.
• Executes activities in a compliant manner that supports an ongoing state of inspection readiness.
• Participates in pre-inspection reviews/checks and provides on-site support during audit/inspections, as requested.
• Handles samples in accordance with local procedures to prevent contamination.
• Accurately and safely performs QC testing in accordance with established laboratory procedures and GMP requirements.
• Labels samples and documents sample collection in accordance with local procedures.
• Performs routine checks (e.g. calibration verification for balances) in accordance with established methods/procedures.
• Immediately reports equipment malfunctions or out-of-tolerance conditions.
• Assists with basic troubleshooting of analytical methods and laboratory issues.
• Escalates persistent or complex issues and provides clear information to enable issue resolution while minimizing downtime and gaining knowledge for future troubleshooting.

Benefits

• company bonus (depending, in part, on company and individual performance)
• company-sponsored 401(k)
• pension
• vacation benefits
• 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
• well-being benefits (e.g., employee assistance program, fitness benefits, and employee clubs and activities)

What This Job Offers

• Job Type: Full-time
• Career Level: Entry Level
• Education Level: High school or GED