Karen Hulsey

• Directed new artwork program as project lead, achieving timely milestones.
• Led team of 4 employees to execute projects on schedule and meet objectives.
• Managed compliance for artwork and product specifications.
• Owned artwork management system to maintain quality standards.
• Utilized SAP system to streamline operational processes and enhance efficiency.
• Cross-trained to support quality release and compliance initiatives, ensuring seamless operations.
• Acted as backup for head of quality assurance, ensuring continuity in operations.

Reviewed production master file records for compliance with 9CFR and corporate standards, ensuring product quality and safety.

• Managed product release processes for Raleigh, NC facility, facilitating timely distribution and adherence to quality standards.
• Oversaw quality management of third-party vendors for raw materials and service providers, improving supplier performance and compliance.
• Conducted audits of raw materials vendors and subcontractors.
• Supervised local vendor assessment tool Safran and managed audit schedules.
• Handled paper audits for Gainesville, GA vendors, contractors, and subcontractors with relevant questionnaires.
• Administered change controls, deviations, internal audits, and external audits across all areas of responsibility.
• Acted as backup liaison for quality assurance across departments. for multiple functional areas.

• Inspected and released all finished goods to ensure quality standards.
• Coordinated inspection and release of raw materials for production, maintaining quality integrity throughout the supply chain.
• Managed QA processes for packaging receiving and distribution departments, ensuring compliance with quality standards.
• Reviewed and accepted new product packaging components for compliance.
• Managed change control process and maintained comprehensive records.
• Supported internal audits in designated areas, contributing to adherence to quality assurance protocols.

• Oversaw all aspects of vaccine production, including media preparation, filling, and shipment coordination.
• Monitored performance indicators, conducted production forecasting, and planned demand for operations.
• Negotiated vendor contracts and managed inventory of raw materials and supplies to ensure operational continuity.
• Ensured adherence to 9CFR HSE specifications and USDA production outlines.
• Maintained departmental standard operating procedures in compliance with Merial controlled document format.
• Supervised one part-time employee in daily operations. to enhance departmental efficiency.

Documented and reviewed production records for accuracy and compliance with regulatory standards.

• Supported department head in optimizing vaccine production processes.
• Performed sterilization of glassware and equipment, ensuring adherence to safety standards.
• Prepared bacterial growth media, facilitating laboratory experiments.
• Applied sterile techniques to ensure contamination-free environments.

• Executed microbiological testing for pathogens, including Salmonella and Listeria, to safeguard product integrity and consumer health.
• Performed E. coli O157 testing to identify contamination risks.
• Conducted quality control testing on pesticides, ensuring compliance with safety standards and enhancing product safety.
• Performed analytical chemical analysis to evaluate product integrity.
• Conducted water testing in accordance with safety standards to evaluate quality and safety parameters. to assess quality and safety parameters.
• Plated bacterial cultures in a controlled laboratory environment to monitor microbial growth. to monitor microbial growth.
• Maintained comprehensive documentation for quality assurance processes across farms, supporting regulatory compliance and operational consistency.
• Ensured adherence to quality assurance protocols throughout operations.

Conducted quality control and quality assurance testing, ensuring compliance with industry standards to uphold product integrity.

Performed sterility testing on finished goods vaccines per 9CFR requirements.

Conducted identification of bacterial and fungal organisms in laboratory settings. in accordance with 9CFR protocols.

Produced tissue cultures that contributed to successful research and development initiatives.

Executed data entry tasks, maintaining accurate records to support regulatory compliance and traceability.