Michael Killian Email & Phone Number

Johnson City, Tennessee, United States

Johnson City, Tennessee Area

Charlotte, North Carolina Area

Bristol, TN (significant Work Force reduction)

• Log, track, evaluate and process document (SOP) and project change controls.
• Batch Record Review and Evaluation.
• Coordinate and review Investigations.
• Perform internal audits, to ensure compliance with Federal and corporate policies
• Respond to Customer Complaints.
• Create Annual Product Reports.

Bristol, TN (Site Listed For sale)

• Manage 6 exempt employees.
• Responsible for Oversight of:
• The stability program
• Complaint investigations
• Plant Investigations
• Manufacturing/ packaging investigations

Bristol, TN

• Oversee the Investigation and CAPA systems
• Create Annual Product Reviews for products produced at the Bristol site.
• Perform batch record review of all batches produced at the Bristol site.
• Responsible for review/ release of components and raw materials for manufacturing at the Bristol site.
• Responsible for review/ release of finished product manufactured/ packaged at the Bristol site.

Johnson City, TN

• Submit Registration Applications for the FDA, Health Canada and other foreign Ministries of Health, for the obtainment of license for new and revised Medical Devices.
• Oversee and Manage the Track Wise electronic CAPA system.
• Perform internal audits.
• Review and approve Nonconformance Reports.
• Review and approve Printed Components, labels, procedures, work instructions, and PCO’s

Bristol, TN (Site closed)

• Log, track, evaluate and process document (SOP) and project change controls.
• Maintain the Change Control and Batch Record Review Data Bases.
• Batch Record Review and Evaluation.
• Coordinate and review Investigations.
• Participate in internal audits, to ensure compliance with cGMP’s and GSK policies.
• Respond to Customer Complaints.

Bristol, TN

• Manage 2 exempt employees.
• Create and revise Local Standard Operating Procedures (LSOP’s).
• Create and revise Batch Documentation (maintained within SAP).
• Batch Record Review.
• Create and monitor Technical Change Controls (TTC) for the creation/ revision of procedures and projects.
• Investigate and respond to customer complaints.

Bristol, TN

• Managed 35 to 40 hourly employees (1st and 3rd rotating shift).
• Planned and maintained production schedule for the Packaging Department.
• Disciplined problem employees.
• Oversaw and coordinated the maintenance of machinery.
• Tracked product flow through the department and developed ways to increase throughput.
• Kept quality and efficiency in line with expected standards.

Johnson City, TN

• Managed 50 to 65 employees, in four departments.
• Oversaw on-the-job instructors, making sure that training packages were kept up to date and helped to develop training criteria and standards.
• Disciplined and/or terminated problem employees.
• Conducted safety inspections in the department, to identify present and potential hazards. Then, worked with maintenance to repair or replace hazardous items found.
• Inventoried and ordered raw… Show more
• Inventoried and ordered raw materials to meet future production needs.