Quality Associate I (TEMPORARY) at EKF DIAGNOSTICS INC – Sound Bend, Indiana

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

REQUIRED QUALIFICATIONS:

• 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)

PREFERRED QUALIFICATIONS:

• 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.

BASIC SKILLS AND ABILITIES:

• 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.

REASONING ABILITIES:

• 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.

LANGUAGE SKILLS:

• 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.

MATHEMATICAL SKILLS:

• 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.

VISUAL ACUITY:

• Close visual acuity to perform an activity such as preparing and analyzing data, transcribing, viewing a computer terminal, and reading.

PHYSICAL DEMANDS:

• 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.

ENVIRONMENT CONDITIONS:

• Well lit, heated/air-conditioned indoor laboratory setting with adequate ventilation.
• The noise level in the work environment is moderate.
• Frequent exposure to low temperatures in controlled refrigerators and/or freezers.
• Occasional exposure to biohazards, fumes and other airborne particles.