Quality Assurance Associate

Responsibilities

• Provide quality oversight and support within a regulated manufacturing environment.
• Review and approve production and quality documentation to ensure accuracy, completeness, and compliance with established procedures.
• Partner with Operations and cross-functional teams to investigate quality events, process deviations, and operational issues.
• Support quality activities including documentation review, product disposition, and compliance monitoring.
• Balance production priorities with quality requirements to ensure timely and compliant operations.
• Assess quality concerns, determine potential impact, initiate corrective actions, and escalate issues when appropriate.
• Participate in investigations, root cause analysis, risk assessments, and corrective/preventive action activities.
• Promote adherence to quality standards, safety requirements, and standard operating procedures.
• Maintain accurate records and ensure data integrity across both electronic and paper-based systems.
• Analyze quality metrics and process data to identify trends, reduce variability, and support continuous improvement initiatives.
• Manage multiple tasks and projects in a fast-paced manufacturing environment.

Qualifications

• Bachelor's degree in a scientific, technical, or related field preferred; equivalent experience may be considered.
• Minimum of 2 years of experience in Quality Assurance, Quality Control, or manufacturing within a regulated environment.
• Knowledge of quality systems, including deviations, non-conformances, investigations, and corrective/preventive actions.
• Understanding of Good Manufacturing Practices (GMP) and Good Documentation Practices (GDP).
• Strong written, verbal, and interpersonal communication skills.
• Proficiency with computer systems and standard business software applications.
• Ability to review, interpret, and maintain technical documentation and records.