Quality Associate ; TEMPORARY

Description

3 months - 6 months

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.

• 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.

• None

• None

• 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)

• 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)…