Quality Associate I (TEMPORARY)

EKF Diagnostics USA (Stanbio Laboratory); South Bend (IN); On-site; USD 30,000 - 45,000; Full time

Job summary

EKF Diagnostics USA (Stanbio Laboratory) is looking for a Quality Associate I to assist in ensuring compliance with the Quality Management System. This temporary full-time role will focus on maintaining product quality through testing, monitoring, and compliance activities over a duration of 3 to 6 months.

The ideal candidate should possess a high school diploma, along with proven experience in quality management systems and production. A strong commitment to quality and good communication skills are essential for this position.

Qualifications

• Legally authorized to work in the United States.
• Proven quality management systems experience.
• Previous experience in production/manufacturing and quality.

Responsibilities

• Perform batch record review and release activities.
• Conduct various testing activities including QC.
• Support quality system activities related to CAPA and NCR.

Skills

Detail oriented

Excellent organizational skills

Ability to analyze quality metrics

Communication skills

Education

High School Diploma or equivalent

Associate or bachelor’s degree in relevant field

Tools

Microsoft Excel

Laboratory equipment

Job description

Summary of Position

The Quality Associate I is responsible for supporting day‑to‑day quality activities to ensure compliance with the Quality Management System, associated procedures, and applicable regulatory requirements. This temporary, full‑time onsite position lasts 3 to 6 months.

Essential Functions

• Partner with other departments to maintain product quality, drive continuous improvement, and ensure accurate and complete documentation.
• Perform batch record review and release activities to ensure documentation is complete, accurate, and compliant with established procedures and quality standards.
• Release materials, components, and finished products.
• Conduct various testing activities including QC, water testing, Total Organic Carbon (TOC), stability tests, and other routine quality tests as assigned.
• Perform environmental monitoring (EM) activities as required.
• Conduct calibration activities for equipment and instruments (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, NCR, and planned deviations.
• Provide validation support including execution and documentation assistance for validation protocols and reports.
• Provide document control support as needed.
• Assist with solution preparation activities following approved procedures and specification requirements.
• Analyze and trend quality data 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, the Quality Management System (QMS), Standard Operating Procedures (SOPs), and related regulations.

Other Functions

• Ensure compliance with safety regulations and maintain a 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 in production/manufacturing and quality.
• 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, and multimeters.
• General knowledge of biological and chemical concepts.
• Familiarity with standards and regulations such as ISO 9001, ISO 13485:2016, and 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, 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 cooperating with employees, customers, and management.
• 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 part of various teams and committees.
• Proven ability to handle multiple projects and meet deadlines 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 (computers, calculators, and copiers).
• 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 basic scientific reasoning and process.
• Apply common sense to carry out instructions in written, oral, or diagram form.
• Define problems, collect data, establish facts, and draw valid conclusions.
• Interpret technical instructions in mathematical or diagram form and handle abstract and concrete variables.

Language Skills

• Read and interpret work‑related documents, procedures, and manuals.
• Communicate effectively; good written and oral communication skills.

Mathematical Skills

• Add, subtract, multiply, and divide all units of measure using whole numbers, fractions, and decimals.
• General knowledge of metric system units (length, area, volume, capacity, mass, weight) and U.S. equivalents.

Visual Acuity

• Close visual acuity to perform activities such as preparing and analyzing data, transcribing, viewing computer terminals, and reading.

Physical Demands

• Work in laboratory, manufacturing, or controlled environments.
• Wear and work in personnel protective equipment (PPE) as required.
• Perform light, non‑strenuous daily laboratory activities.
• Hear, understand, and distinguish speech.
• Dexterity and coordination to handle small components.
• Manual dexterity for handling samples and precise calibrations.
• Frequent repetitive motions with wrists, hands, or fingers to operate keyboard and mouse.
• Stand for prolonged periods, occasionally move throughout the facility, and occasionally lift or carry objects up to 25 pounds.

Environment Conditions

• Well‑lit, heated/air‑conditioned indoor laboratory with adequate ventilation.
• Moderate noise level.
• Frequent exposure to low temperatures in controlled refrigerators/freezers.
• Occasional exposure to biohazards, fumes, and airborne particles.