QC Specialist
On-siteIndianapolis, Indiana, United States
Job Summary
Conduct accurate and timely testing of routine lab samples in accordance with GMP and safety guidelines. Execute analytical test methods, perform data entry, and verify analytical data through second-person verification. Initiate investigations for deviations, troubleshoot equipment, and maintain routine qualifications and calibrations. Identify opportunities for improvement and communicate them to leadership. Train others within the lab and maintain a safe work environment while supporting HSE goals. Work 8-hour days Monday through Friday with potential overtime, summer/winter shutdowns, and off-shift operational support. Requires proficiency with LIMS and SAP systems.
Required Qualifications
- Accurately and safely performs analytical test methods or related support activities as per procedures or protocols and reviews that results conform to standards
- Performs data entry and reviews own work for accuracy in accordance with laboratory procedures, standards, and GMP requirements
- Recognizes when a deviation from procedures, etc. has occurred and initiates an investigation, notifies supervision
- Verifies (SPV) analytical data of other analysts within the lab as required
- Identifies and communicates opportunities for improvement initiatives in daily work activities
- Troubleshoots equipment and methods as required
- Trains others within lab
- Performs routine equipment qualifications/calibrations or maintenance through execution of well-defined protocols
- Participates in laboratory investigations
- Maintains a safe work environment, works safely, and is accountable for supporting all HSE Corporate and Site goals
- Effectively utilize time management skills to prioritize work, ensuring all requested due dates and commitments are met
- Identify and implement continuous improvement efforts related to the execution of above job responsibilities
- Proficiency with computer systems, including Microsoft Office products, LIMS (list other lab systems, Smart Lab, Darwin, SAP), etc.
- 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
- Ability to repetitively lift to 20 pounds
- Demonstrated strong oral and written communication and interpersonal interaction skills
- Ability to work 8-hour days – Monday through Friday
- Ability to work during summer/winter shutdown as needed
- Ability to work overtime as required
- Tasks require repetitive motion and standing for long periods of time
- May be required to respond to off-shift operational issues
- Position is full-time, 8:00 am- 5:00 pm Overtime as needed
Desired Qualifications
- Prior experience with SAP/EWM
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