Senior Quality Assurance Analyst

A collective energy and ambition. A place where you can make a real difference.

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  Assist in administering, maintaining, and continuously improving the site's Quality Management System (QMS).

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  Support compliance with regulatory requirements and internal quality procedures.

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  Analyze QMS performance metrics and identify opportunities for process improvement.

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  Assist in preparing Quality Management Review and Annual Product Review reports, including quality system trends and performance metrics.

• Maintain laboratory document control processes, including document preparation, review, routing, approvals, and revisions.

• Ensure required training documentation is completed and maintained.

• Support change control activities by monitoring status, tracking implementation, and reporting progress.

• Assist with impact assessments, implementation plans, effectiveness verification, and change control closure activities.

• Utilize statistical tools to evaluate and trend laboratory, product, and process performance.

• Analyze technical data and present findings and recommendations to Quality leadership.

• Monitor quality trends and escalate adverse findings when appropriate.

• Monitor non-conformance investigations and associated corrective action status.

• Assist with investigations, root cause analyses, and implementation of corrective and preventive actions (CAPA).

• Support deviation management activities.

• Monitor calibration and preventive maintenance schedules.

• Maintain calibration records and supporting documentation.

• Support equipment, process, cleaning, software, and qualification validation activities.

• Support internal and external audits, including scheduling and audit preparation.

• Assist with audit report preparation and documentation.

• Coordinate responses to audit observations and corrective actions.

• Support inspection readiness and compliance assessments.

• Assist with supplier investigations and corrective actions.

• Support supplier risk assessments.

• Maintain supplier qualification and assessment documentation.

• Support Environmental Monitoring, Chemical Control, Pest Control, and other site quality programs.

• Document monitoring data and perform trend analysis.

• Escalate adverse quality trends to the QA Supervisor.

• Ensure compliance with regulatory requirements and internal procedures.

• Participate in continuous improvement initiatives focused on quality, compliance, efficiency, and data integrity.

• Assist with implementation of process improvements.

• Mentor and train Quality Analysts and Quality Inspectors on laboratory equipment operation and troubleshooting.

• Support Quality Control testing activities and training as needed.

• Support laboratory inventory management activities.

• Perform additional duties as assigned.

• Bachelor's degree required.

• Minimum of 3 years of Quality experience in a regulated manufacturing environment.

• Experience working under Good Documentation Practices (GDP) and current Good Manufacturing Practices (cGMP).

• Knowledge of laboratory terminology, equipment, testing methods, and standard laboratory procedures.

• Working knowledge of ISO standards and FDA 21 CFR regulations.

• Strong organizational, communication, and time management skills.

• Excellent attention to detail.

• Ability to work independently and effectively prioritize multiple assignments in a fast-paced environment.

• Strong analytical skills with the ability to interpret technical data and make recommendations.

• Proficiency with Microsoft Office Suite.

• Experience with SAP and Agile systems.

• Experience supporting Quality Management Systems (QMS).

• Experience with document control, change control, CAPA, audits, supplier quality, or validation activities.

• Experience utilizing statistical tools for quality data analysis and trend reporting.

• Previous experience supporting Environmental Monitoring or other quality compliance programs.

• Experience mentoring or training laboratory personnel.

Experience using laboratory instrumentation including, but not limited to:

• UV/Visible Spectroscopy (UV/VIS)

• High Performance Liquid Chromatography (HPLC)

• Infrared Spectroscopy (IR)

• Moisture Analyzers

• Autotitrators

• Analytical Balances

• Viscometers

• Measuring equipment and other standard laboratory instrumentation