Quality Associate I (TEMPORARY)

EKF DIAGNOSTICS INC•South Bend, IN

1d•Onsite

About The 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.

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)
Project a positive company image by interacting with fellow employees, customers, and management in a cooperative, supportive, and courteous manner; displays a professional attitude.
Detail oriented with a high level of accuracy, efficiency, and accountability.
Possess a strong commitment to product quality and compliance.
Excellent organizational skills to meet goals and set priorities.
Ability to work independently and as a member of various teams and committees.
Proven ability to handle multiple projects and meet deadlines; work in a fast-paced environment.
Versatility, flexibility, and a willingness to work within constantly changing priorities with enthusiasm
Willingness to pivot between lab testing, documentation review, and floor support.
Ability to operate related office equipment, such as computers, calculator, and copier.
Able to work with small tools and electronic equipment to test and inspect.
Demonstrated ability to analyze and interpret information.
Ability to perform repetitive tasks and use laboratory/manufacturing instruments.
Working knowledge of Microsoft Excel, Word, and Outlook.
Able to understand the basic reasoning and process of the scientific method.
Ability to apply common sense understanding to carry out instructions furnished in written, oral, or diagram form.
Ability to define problems, collect data, establish facts, and draw valid conclusions.
Ability to interpret an extensive variety of technical instructions in mathematical or diagram form and deal with several abstract and concrete variables.
Ability to read and interpret work related documents, procedures, and manuals.
Ability to communicate effectively; good written and oral communication skills; ability to read, write, speak, and understand the English language.
Ability to add, subtract, multiply, and divide in all units of measure, using whole numbers, common fractions, and decimals.
General knowledge of the metric system units (length, area, volume, capacity, mass, and weight) and U.S. equivalents.
Close visual acuity to perform an activity such as preparing and analyzing data, transcribing, viewing a computer terminal, and reading.
Ability to work in a laboratory, manufacturing, or controlled environment.
Must be able to wear and work in personnel protective equipment (PPE) as required.
Light physical activity performing non-strenuous daily activities in a laboratory setting.
Ability to hear, understand, and distinguish speech.
Dexterity and coordination are necessary to handle small components.
Manual dexterity required for handling samples and performing precise calibrations.
Frequent repetitive motions that may include the wrists, hands and/or fingers to operate keyboard and mouse.
Frequently stand for prolonged periods of time.
Occasionally move about inside the facility to access office machinery, correspond with other departments, attend meetings/training, etc.
Frequently lift, carry, push, pull or otherwise move objects up to 10 pounds; occasionally carry, push, pull or otherwise move objects up to 25 pounds.
Occasionally required to climb or balance; squat, stoop, kneel, crouch, or crawl; and smell.
Occasionally reaching for items above and below desk level.
The ability to hear, understand, and distinguish speech.
Frequently communicate information and ideas with others to exchange information and understanding. Able to exchange accurate information in these situations.

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.