Keith Perry
Raleigh
Summary
25 + years Extensive manufacturing experience in FDA regulated environments with specific knowledge of good documentation/clean room practices, batch release requirements, CAPA, internal audits and regulatory inspections. Proven expertise and practical experience in electronic manufacturing systems, knowledge of good manufacturing practices (GMP), principles to drive process improvement, efficiency and sustainable corrective and preventive actions. Energetic, passionate leader with focused on building, developing and motivating high performing teams and leaders for tomorrow.
Operations professional with solid background in streamlining processes and enhancing operational efficiency. Known for effective team collaboration and achieving results in dynamic environments. Skilled in process optimization and problem-solving, with reliable and adaptable approach to changing needs.
Overview
33
33
years of professional experience
Work History
Operations Specialist
BCG Merck
01.2012 - Current
- Reporting directly to the Associate Director of Production, provided overall direction, coached and developed team who led daily activities in processing.
- Developed Training programs for New Hire training
- Assisted in all aspects of manufacturing operation, including safety, productivity, process maintenance, process engineering, conversion loss, customer service, continuous improvement, shift planning, training, Corrective and Preventive Action (CAPA), and employee engagement.
- Lead and support daily Tier meetings to facilitate flow of information up/down through the organization.
- Escalate issues as needed to ensure the right support/awareness is given to issues as they arise.
- Lead continuous improvement projects that increase compliance, simplify/standardize activities and gain efficiencies.
- Lead cross-functional teams in Root Cause Analysis and CAPA Plan development for out-of-specification product events.
- Directed and approved non-conformances, ensuring determination of root cause, implementation of sustained CAPAs and compliance with FDA requirements.
- Evaluated micro and particulate trends and implemented sustainable corrective actions, decreasing in-process contaminants 25%.
- Interface with regulator agencies (FDA) Subject Matter Expert (SME) for Visual Inspection Qualification Process.
Senior Tech/Production Lead
VMF, Merck
01.2008 - 01.2012
- Maintained customer (internal/external) and patient focus in an effort to deliver an effective and affordable product.
- Managed team performance through presence on the Shop Floor and appropriate team metrics. Communicated the appropriate information through the agreed-upon channels and shared learnings with other departments.
- Lead Quality investigations and establish Corrective and Preventive Actions (CAPAs) to prevent reoccurrence.
- Led improvements in Product release time for batch processing streams.
- Prepared, reviewed, rejected, approved and disseminated standards of protocol, testing batch records and assisting validation protocols.
Production Technician
Burt’s Bees
01.2006 - 01.2008
- Responsible for proper operation of equipment
- Performed line changeovers and set up equipment
- Ensured proper manning on the production line
- Completed work zone control sheets.
- Maintained Good Manufacturing Processes.
- Maintained excellent team-oriented working relationships among team members
Production Technician
Glaxo Smith Kline
01.1995 - 01.2004
- Perform complex mechanical and electrical troubleshooting of automated packaging, manufacturing and material handling equipment within a GMP working environment.
- Ensured compliance with all GMP rules, product documentation, specifications, SOPs, and FDA requirements as required.
- Reassemble equipment after completion of inspections, testing, or repairs.
Senior Packaging Machine Operator
Glaxo Smith Kline
01.1993 - 01.1995
- Submitted and/or maintained and distributed reports related to attendance, labor, efficiency, safety, scrap and others as needed.
- Reviewed records to ensure they were complete, accurate and compliant with cGMP requirements. Provided Quality verification of batch related labels and samples.
- Independently performed and cleaned, change-overs and set ups of multiple pieces of equipment in support of effective operations in accordance with required timeframes and cGMP documents, standard work documents, and other instructional materials.
Education
Bachelor of Arts - Business
Bachelor of Arts - Business Administration
Strayer University
Raleigh, NC06-2012
Associate of Arts - Maintenance
Wilson Community College
Wilson, NC06-2005
Skills
- Process Execution
- Project Management
- Troubleshoot
- Interface with Regulatory Agencies
- Foster Teamwork and Cross Collaboration
- Pharmaceutical Industry
- Regulatory Compliance
- Analytical Problem Solving
- Conflict Resolution
- Team Building
Timeline
Operations Specialist
BCG Merck
01.2012 - Current
Senior Tech/Production Lead
VMF, Merck
01.2008 - 01.2012
Production Technician
Burt’s Bees
01.2006 - 01.2008
Production Technician
Glaxo Smith Kline
01.1995 - 01.2004
Senior Packaging Machine Operator
Glaxo Smith Kline
01.1993 - 01.1995
Bachelor of Arts - Business
Bachelor of Arts - Business Administration
Strayer University
Associate of Arts - Maintenance
Wilson Community College
OTHER RELEVANT EXPERIENCE
- Project planning and creation of a document control room to store critical records associated with Batch Records such as LYO records, Autoclave Records, and associated records supporting the Batch Record.
- Reducing Batch Records not being approved in a timely manner by 50% and increasing shipping by 80% due to this newly designed control room to turn over Batch Records in a timely manner.
- Worked on a team planning of SAP being launched at BCG using Hoshin Kanri Project. This was a four-step process with the help of West Point in achieving this deployment.