This job was last updated on May 27, 2025 4:13 PM.

Job Summary:

This position is responsible for performing Quality Assurance activities with a focus on risk management, report writing, and deviation handling. The critical skills for this role are demonstrable technical writing abilities and a drive towards continuous improvement. The position will support in carrying out time sensitive projects. This position reports directly to the Director of Quality.

Here's What Your Day-to-Day Looks Like:

Essential Duties and Responsibilities

• Conducts risk assessment and root cause analysis using Quality tools (FMEA, gap analysis, etc.)
• Familiar with regulatory guidance and proposed changes as they apply to 503b manufacturing facilities.
• Assists with studies to inspect, test, and evaluate the reliability of manufacturing processes, products, and equipment.
• Performs trending on key metrics to support Product Annual Review and Quality Management Review.
• Supports the CAPA program. Works cross-functionally to complete Corrective and Preventative Actions (CAPAs) in a timely manner.
• Conducts CAPA effectiveness checks and documents results.
• Attends all required meetings and provides clear, professional verbal and email communication.
• Performs other duties, such as writing deviations, as

Skills and Experience Required

• Bachelor’s degree in scientific discipline/engineering strongly preferred.
• At least three years(preferred) of practical experience of in a Quality role in an FDA regulated company.
• Experience working to cGMP guidelines and demonstrated expertise in variety of the field’s concepts, practices, and procedures.
• Preferred: Continuing education such as ASQ or Six Sigma certification.
• Experience working with Production or Manufacturing.
• Must exhibit excellent verbal and written communication skills.
• Must exhibit excellent attention to detail.
• Exceptional computer skills (data entry, Microsoft Office products, Adobe, inventory management software, eQMS).
• Ability to work as part of a small team in a fast-paced environment.
• Possess time management skills and the ability to work independently, multitask, complete projects according to deadlines.

Additional Notes

• Must be willing and able to gown for ISO 8 area.