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.• Oversee CAPA tracking and trending.

Bristol, Tn (Site Listed For Sale)

• Manage 6 exempt employees.• Responsible for Oversight of:• The stability program• Complaint investigations• Plant Investigations• Manufacturing/ packaging investigations• The CAPA system • Annual Product Reviews• Incoming raw materials and components inspection/ release.• Batch Record review – bulk, intermediate and finished goods release.• Change Control system.• Internal auditing of the Bristol site.

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.• Create Annual Product Reports.• Assist with CAPA tracking and trending.

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.• Investigate and Respond to Internal Investigations (NOE’s).• Consistently provide timely and accurate resolution of issues impacting… Show more • 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.• Investigate and Respond to Internal Investigations (NOE’s).• Consistently provide timely and accurate resolution of issues impacting the Packaging Department (such as Investigations and In-Process Variances). • Conduct/ participate in OE/ Lean Sigma events.• Serve as a supplemental supervisor in the Packaging Department.• Train Packaging Associates on new and revised procedures/ ways of working (WOW).• Auditing: • Serve as an auditor for Level 1 internal Packaging Department audits and Level 2 internal plant wide audits• Serve as Departmental Liaison during GSK Level 3 and FDA audits.• Respond to and correct audit findings (CAPA).• Act with a sense of urgency in developing creative solutions that address both business and technical challenges. • Respond to / complete assigned tasks in SAP.• Serve as Administrator of the Systech Vision Systems and AllFill Oral Suspension filling machine.• Participate in validation activities in the Packaging Department.• Member of the Bristol Site Quality Council, which sets quality policy for the site operations. Show less

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 • 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 materials to meet future production needs.• Tracked the wear of critical machine parts and scheduled the replacement or refurbishment of said parts, once maximum wear limits were reached. • As a trained ISO auditor, performed audits to help maintain plant ISO 9002 certification.• Responsible for keeping quality and efficiency in line with expected standards. • Responsible for keeping payroll , for the shift, at or under budget. • Responsible for keeping production waste under Department standards. Show less