Technician – QC – IAPI

Location: Indianapolis

Technician – QC – IAPI page is loaded## Technician – QC – IAPIlocations:
US, Indianapolis INtime type:
Full time posted on:
Posted Todayjob requisition :
R-105439

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…