Quality Assurance Engineer

About the role

This role is an Onsite Role requiring full-time presence at our Oxford, NC office. The role drives culture change in the organization towards a harmonized, consistent Quality Unit and expectation.

Responsibilities

• Quality Assesses the impact of deviations, CAPAs, and associated change requests on the validation status of equipment and/or systems.
• Aid in defining, testing, and implementing comprehensive guidelines and procedures for all manufactured products to ensure they meet all regulatory and customer requirements.
• Support and review Quality Investigations, Nonconformance(s), and Quality Complaints assigned to the Oxford location.
• Identify and lead continuous improvement opportunities within quality systems and other areas as appropriate.
• Maintain production quality performance through audits, inspections, and statistical analysis.
• Develop and maintain quality procedures, work instructions, and control plans.
• Lead continuous improvement initiatives focused on reducing defects, waste, rework, and downtime.
• Contribute to the development of process controls to maintain consistent product quality.
• Train production personnel on quality requirements and best practices.
• Promote a culture of continuous improvement and operational excellence.
• Participate in cross-functional teams to resolve quality and process-related issues.

Required Knowledge & Skills

• Bachelor of Science degree, such as Engineering, Microbiology, Chemistry, with minimum of 5 years of experience.
• Experience working in a cGMP environment and good understanding of regulations and industry guidance including but not limited to FDA.
• Strong analytical and problem-solving skills.
• Ability to manage multiple projects simultaneously.
• Strong collaboration and stakeholder management skills.
• Results-driven with a focus on continuous improvement.
• Knowledge of standard business software (Word, Excel, Outlook, PowerPoint).
• Excellent oral and written skills coupled with the ability to succeed in a teamwork-oriented atmosphere.
• Demonstrated, hands-on experience with cleaning validation activities.
• Proficiency in standard business software (Word, Excel, Outlook, PowerPoint).
• General experience with SAP or other ERP system.
• Experience leading or participating in auditing activities for cGMP compliance.