Quality Manager Lab

PROFESSIONAL SUMMARY

SKILLS

WORK HISTORY

SHAWN HEARN

Ellenwood, GA 30294

404-***-**** - *********@*****.***

Meticulous Quality Manager offering over 15 years of experience. Demonstrates seasoned skills in 21 CFR 111, research and development, due diligence and investigations. Thrives as hardworking, reliable and resourceful leader with analytical mentality.

Quality Control

CAPA management

Compliance monitoring

Compliance documentation

Internal audits

Document review

Vendor / supplier performance

management

Root cause deviation investigation

10/2008 to 07/2022 Compliance Analyst / Quality Manager Century Systems – Atlanta, GA

Facilitated Good Manufacturing Practices and FDA inspections. Achieved 0 non conformance cGMP 21 CFR 111 dietary supplements audit. Supported and trained staff on current GMPs.

Developed improvement and corrective action plans to bring operations in line with requirements.

Stayed current with latest changes to applicable regulatory standards and company procedures.

Prepared SOPs, documentation and records for upcoming audits and inspections. Drafted and presented comprehensive reports to upper management and audit team regarding issues and recommendations.

Secured consistency in quality planning, control, insurance and improvement. Supervised quality programs to reduce overdue compliance activities. Managed full life cycle of assigned audits to align with departmental procedures. 07/2008 to 07/2022 Technical Director / Quality Manager Bronner Bros. Inc. – Atlanta, GA

Guided, coached and led project teams, delegating tasks and evaluating performance and progression of project pace.

EDUCATION

REFERENCES

CERTIFICATIONS

Assessed expected technical challenges and developed proactive solutions. Monitored production operations for quality and compliance with standards. Oversaw implementation of new technological improvements to increase efficiency. Supervised testing of equipment and components to identify defects. Updated quality control standards, methods and procedures to meet compliance requirements.

Provided observations, took measurements and performed tests at various stages according to quality control plan.

Inspected inbound and outbound products for compliance with company policies, procedures and industry standards.

Wrote and implemented new rework procedures to standardize processes and streamline workflow.

Managed and archived quality documentation and participated in internal and external quality audits.

Equipped and organized facility to comply with company strategy for online and offline quality controls.

Sorted products and provided expertise on non-conforming product requirements. Adhered to all legal, safety and health standards. Rejected defective products and approved correct products. Calibrated instruments and scales in production area and quality lab. Directed inspectors and technicians to ensure satisfactory final output. Collaborated with contract representatives and oversaw quality control implementation and reporting.

03/2005 to 05/2006 Laboratory Technician

Xavier University of Louisiana – New Orleans, LA

Synthesized nanoparticles of complex fluorides.

Oversaw items in inventory and reordered before supplies diminished. Managed operational documents and produced reports detailing activities. Maintained laboratory compliance with applicable guidelines and laws. Developed and monitored quality assurance guidelines for laboratory work. 05/2006 Bachelor of Science: Biochemistry

Xavier University of Louisiana - New Orleans, LA

Available upon request

Lean Six Sigma Green Belt

ID# 27844294

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