Quality Associate I (TEMPORARY)

EKF Diagnostics•Sound Bend, IN

1d•Onsite

About The Position

TEMPORARY, FULL-TIME Onsite Position 3 months - 6 months SUMMARY OF POSITION: The Quality Associate I is responsible for supporting day-to-day quality activities to ensure compliance with the Quality Management System, and procedures therein, and applicable regulatory requirements. ESSENTIAL FUNCTIONS, included but not limited to: Partner with other departments, as needed to maintain product quality, drive and/or support continuous improvement, and ensure accurate and complete documentation. Perform batch record review and release activities to ensure all documentation is complete , accurate, and compliant with established procedures and quality standards. Perform release activities for materials, components, and finished products, etc. Conduct various testing activities, including but not limited to quality control (QC), water testing, Total Organic Carbon (TOC), stability-related activities, and other routine quality testing as assigned. Perform environmental monitoring (EM) activities as required. Conduct calibration activities for equipment and instruments, including but not limited to weights, thermometers, thermocouples, and other measurement devices. Assist with troubleshooting, root cause analysis, and continuous process improvement initiatives to enhance product quality and operational efficiency. Support quality system activities related to CAPA (Corrective and Preventive Actions), NCR (Non-Conformance Reports), and planned deviations. Provide validation support as needed, including execution and documentation assistance for validation protocols and reports. Provide document control support as needed. Assist with solution preparation activities as needed, following approved procedures and specification requirements. Perform analysis and trending of Quality data as needed to support investigations, process monitoring, and continuous improvement. Support internal and external audits, as required. Adhere to current Good Manufacturing Practices (cGMP). Comply with Company policies, Quality Management System (QMS) and Standard Operation Procedure (SOPs), etc. OTHER FUNCTIONS: Ensure compliance with safety regulations and procedures are implemented and followed; Maintain clean and safe work area. Assist as needed in other areas of the company where training requirements have been completed. Perform other duties as assigned. SUPERVISORY RESPONSIBILITIES: None TRAVEL: None

Requirements

Legally authorized to work in the United States.
High School Diploma or its equivalent.
Proven quality management systems experience.
Previous experience of production/manufacturing and quality experience.
Knowledge of quality system processes such as batch record review, product release, CAPA, deviations, NCRs, document control and validation support.
Familiarity with statistical process control principles used to monitor and ensure the quality of the production process.
Ability to perform routine testing and interpret basic quality data.
Good understanding of laboratory equipment (e.g., pipettes, scales, pH meters).
Experience using inspection and measurement tools such as calipers, micrometers, multimeters, or similar equipment
General knowledge of biological and chemical concepts.
Familiarity with various standards and regulations such as ISO 9001, ISO 13485:2016, the Quality System Regulation (21 CFR Part 820)

Nice To Haves

Associate or bachelor’s degree in Biology, Chemistry, Quality, Life Sciences, Engineering, or a related scientific/technical field.
Experience supporting quality audits, root cause analysis, or corrective actions
Experience with document control, CAPA, and internal auditing.
Ability to analyze quality metrics and process data to identify improvement opportunities.
Direct laboratory experience in a biology, chemistry, or medical environment.
Experience with performing QC Testing, including assays
Ability to operate laboratory equipment and understand complex testing protocols including analytical pipetting, enzyme assays, High-Performance Liquid Chromatography (HPLC), and electrophoresis.
General knowledge of Good Documentation Practices (GDP) and Good Manufacturing Practices (GMP) or similar.

Responsibilities

Partner with other departments, as needed to maintain product quality, drive and/or support continuous improvement, and ensure accurate and complete documentation.
Perform batch record review and release activities to ensure all documentation is complete , accurate, and compliant with established procedures and quality standards.
Perform release activities for materials, components, and finished products, etc.
Conduct various testing activities, including but not limited to quality control (QC), water testing, Total Organic Carbon (TOC), stability-related activities, and other routine quality testing as assigned.
Perform environmental monitoring (EM) activities as required.
Conduct calibration activities for equipment and instruments, including but not limited to weights, thermometers, thermocouples, and other measurement devices.
Assist with troubleshooting, root cause analysis, and continuous process improvement initiatives to enhance product quality and operational efficiency.
Support quality system activities related to CAPA (Corrective and Preventive Actions), NCR (Non-Conformance Reports), and planned deviations.
Provide validation support as needed, including execution and documentation assistance for validation protocols and reports.
Provide document control support as needed.
Assist with solution preparation activities as needed, following approved procedures and specification requirements.
Perform analysis and trending of Quality data as needed to support investigations, process monitoring, and continuous improvement.
Support internal and external audits, as required.
Adhere to current Good Manufacturing Practices (cGMP).
Comply with Company policies, Quality Management System (QMS) and Standard Operation Procedure (SOPs), etc.
Ensure compliance with safety regulations and procedures are implemented and followed
Maintain clean and safe work area.
Assist as needed in other areas of the company where training requirements have been completed.
Perform other duties as assigned.