Lee Bateman Email & Phone Number

Nashville, Tn, Us

Kalamazoo, Mi, Us

Manage, oversee, and continually improve the QMS of NuLine Sensors. Work directly with executive leadership to bring about positive changes in efficiency and effectively create and maintain sustainable compliance across the organization.

Nashville, Tennessee, Us

Nashville, Tennessee, Us

Managed, authored protocols, executed, and approved compliance-focused validation activities from equipment qualification and process validation to software validation (CSV).

Nashville, Tn, Us

Working with a small Quality team to establish the company’s Quality System from scratch and to file a 510(k). Establishing the Design History File and related verification and validation activities. Created and approved various procedures, work instructions, and forms across multiple teams within the company. Wrote and executed validation protocols for 3D printers. Worked with laboratories and suppliers to initiate and finalize analytical and biocompatibility testing for our products. Active team member providing a Quality System perspective for new and ongoing R&D projects related to our products and manufacturing processes.

Kentwood, Mi, Us

In charge of all validation activities and ensuring sustainable compliance while balancing company and customers needs.

Kentwood, Mi, Us

Main focus currently is writing and executing IQ, OQ, PQ, and PPQ for equipment that manufactures components for finished medical devices. I am qualifying the equipment and validating the associated processes. I am also helping the business find its regulatory path as they rapidly expand. Finally, my duties include Process Excellence initiatives to streamline existing Quality System processes to create sustainable regulatory compliance.

Us

Consulting as a Lead Investigator / Compliance Specialist for Manufacturing and Quality System nonconformances in a Consent Decree environment.

Us

• Initiated, lead, wrote, reviewed, and approved investigations using the EtQ/Symphony electronic system for manufacturing nonconformances in a Consent Decree environment.• Closed investigations in a timely fashion to assist McNeil in restarting their consumer liquid dose manufacturing operations while the company was under Consent Decree.• Met with project teams, Operations, and Quality Assurance teams to ensure investigations were compliant and closed on-time.• Interviewed and collaborated with various departments to gather valuable information to close investigations in a timely fashion.• Performed root cause analyses.

Managed Document Control and Training. Re-engineered and managed Change Control and Training. Provided support for Manufacturing QA. Worked with all departments to improve existing processes; created risk-based GMP-compliance assessments, refined warehousing procedures and flow, created new document templates, managed document changes, made new Quality Systems documents effective, and facilitated root cause analysis and managed closure of the resulting CAPA action items.

Managed projects utilizing Lean Six Sigma Black Belt training, contributed to concept designs, and handled all administrative duties.

Improved, oversaw, and maintained compliance to cGMPs and international (ISO) regulations of the following Quality Management System elements: lot release, corrective actions, preventive actions, internal audits, root cause analyses, deviations, management reviews and associated action items, regulatory audit finding responses, Continual Improvement per ISO 9001, Customer Satisfaction per ISO 9001, and gathering, analysis, and presentation of QMS metrics. I also transitioned the QMS from a paper-based system to an electronic system with no additional expense.

Nashville, Tn, Us

Ensured donor suitability and recipient safety by reviewing the donor medical and social history and microbiological data. Used my prior experience as a member of tissue recovery teams and processing donor tissues to procure, process, and confirm suitability of donated human tissues.