Quality Associate ; TEMPORARY

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.

• 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.

• 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.

None

None

• 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.

• 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.

• 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…