Senior Quality Assurance Analyst

About the role

A collective energy and ambition. A place where you can make a real difference. We’re a company that genuinely cares about our people, our products, our consumers and the environment. Our unique, informal culture champions courage, determination and collaboration.

Responsibilities

• Assist in administering, maintaining, and continuously improving the site's Quality Management System (QMS).
• Support compliance with regulatory requirements and internal quality procedures.
• Analyze QMS performance metrics and identify opportunities for process improvement.
• Prepare 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.
• 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.
• Aid in investigations, root cause analyses, and implementation of corrective and preventive actions (CAPA).
• Support deviation management activities.
• Maintain calibration and preventive maintenance schedules.
• Support equipment, process, cleaning, software, and qualification validation activities.
• Assist with supplier investigations and corrective actions.
• Support supplier risk assessments.
• Maintain supplier qualification and assessment documentation.
• Document monitoring data and perform trend analysis.
• Escalate adverse quality trends to the QA Supervisor.
• Ensure compliance with regulatory requirements and internal procedures.
• Support laboratory inventory management activities.
• Perform additional duties as assigned.

Qualifications

• 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.