Technician-QC-IAPI-Bulk Testing Lab

Role Summary

Technician – QC in the Indianapolis Active Pharmaceutical Ingredient (IAPI) group performs accurate and timely testing of routine and some non-routine lab samples in accordance with GMP and safety guidelines. The technician completes second-person verification of others' results and participates in laboratory analytical investigations, equipment evaluations and qualification, and some quality system improvement initiatives by executing well-defined protocols and procedures. The technician shares technical information and best practice within plant sites or group.

Responsibilities

• Verify analytical data of other analysts within the lab as requested.
• Accurately and safely perform analytical test methods or related support activities as per procedures or protocols. Use technical knowledge in the review and interpretation of data for conformances to procedures, standards, protocols, and/or real-time recognition of aberrant data and results.
• Perform data entry and review own work for accuracy in accordance with laboratory procedures, standards and GMP requirements.
• May perform holistic review of data for release of data from the laboratory.
• Recognizes when a deviation from test methods or procedures has occurred and initiates analytical investigations and participates in Root Cause Investigations.
• Participates in investigations for deviations and assists in troubleshooting equipment and methods as required.
• Assist in improvement of quality systems by creating or revising worksheets and other lab documentation systems; identify opportunities for improvement in daily activities; review SOPs for executable as written.
• Assist with drafting protocols for non-routine testing or validation and in developing equipment qualification protocols; perform routine equipment calibrations or maintenance; comply with and assist with implementing safety standards.
• Execute notification to management when required by procedures or standards; initiate lab deviations; train and mentor others and assist with developing training materials.

Qualifications

• Required: Associate’s degree in a science field related to the lab (e.g., chemistry for chemistry labs) or 1+ years of demonstrated relevant experience in a GMP analytical lab.

Skills

• Proficiency with computer systems (LIMS, Empower, Excel, etc.).
• Ability to work in a lab environment, including wearing appropriate PPE and other safety equipment.
• Strong math and documentation skills; strong oral and written communication and interpersonal skills.

Education

• Associate’s degree in science field related to the lab or 1+ years of GMP analytical lab experience.

Additional Requirements

• Sunday-Thursday 8 Hour Evening to Night Shift; overtime or weekend work as necessary.
• Tasks may require repetitive motion and standing for long periods.
• Must be able to lift at least 5 liters of liquid.