Plant Manager Process Improvement

Jeffrey Morgan

Burlington, NC *****

************@***.***

+1-919-***-****

Work Experience

Manufacturing Quality Supervisor

KBI Biopharma - Durham, NC

March 2022 to June 2023

Batch Record Review

Deviation writing and Investigation

Manufacturing Process Quality

Direct Supervisor of 3 Quality Specialists.

Quality/EHS/Training Manager

FXI - High Point, NC

February 2020 to March 2022

Responsible for all Training in facility. Tracked all Quality issues and reported back to plant manager. Deviation and CAPA documentation and investigation . Powder Manufacturing Supervisor. Fluid Bed Dryers

HERBALIFE MANUFACTURING - Tea, SD

November 2014 to December 2019

· Responsible for Operation of three Fluid Bed Dryers

· Leading a team of 22 Manufacturing Operators

· Review of EBR for Tea Manufacturing.

· Update SOP’s and Safety Procedures

· Review of Production Log books.

· Writing investigations for Quality issues.

· Process improvement using LEAN MFG TECHNIQUES

Filling Supervisor

HOSPIRA Formulation

February 2013 to August 2014

• Responsible for Formulation and Filling of Solution and Emulsion products.

• Leading a team of 9 Operators.

• Batch record reviews.

• Participating on Process Improvement Teams.

Writing investigations for Quality issues

SERVICES Associate Aseptic Manufacturing/ Filling Manager AAI PHARMA

November 2011 to February 2013

• Responsible for Component Prep, Formulation Inspection, Packaging, and Sterile Filling of Commercial as well as Clinical batches for outside clients.

Supervise 9 Techs in all Departments.

• Responsible for schedule attainment which includes P&L

• Working on Process and equipment improvements as well as SOP and Batch Record changes.

Aseptic Filling Supervisor

MERCK INC

May 2010 to November 2011

• Scheduled two fill lines and conducted training and SOP updates

• Conducted Training and implemented 5S activities.

• Responsible for validation of new procedures and changes.

• Led Kaizen team in the standardization of line clearances and cleaning. Production Supervisor

ConAgra Foods

January 2008 to December 2009

• Responsible for 4 Automated Packaging lines and 6 Cutting lines

• Supervised 80 employees

GLAXOSMITHKLINE, Production Supervisor 2000-2008

• Set up three state of the art Assembly/Packaging lines in new MD PI facility.

• Involved in all Validation of Assembly/Packaging Lines and FAT’s

• Conducted line training for entire shift of 40 operators and 4 shift leaders

• Coordinated the production of Advair on 4 Blend/Fill lines and 4 Assembly/Packaging line.

• Conducted training on 5’s Activities for entire Advair Department. Performed Quality Auditing for ADVAIR Facility for 3 years GLAXOSMITHKLINE, Production Leader 1999 – 2000

• Initiated a program to increase production and efficiencies throughout the organization

• Maintained production equipment for installations in the Zebulon, North Carolina plant.

• Provided technical assistance and logistics problem solving for equipment.

• Oversaw HAZMAT disposal and consulting

• Wrote SOP's and JSA’s for Assembly Equipment.

• Trained as a QA Validation Technician responsible for Facilities and Process Validation start up.

Production Coordinator

NOVO NORDISK PHARMACEUTICAL INDUSTRIES

January 1996 to December 1999

• Recognized for outstanding performance and leadership skills in the production environment

• Achieved senior leadership role to train incoming operators

• Completed first cartridge stability batches under severe time constraints

• Assisted with NNPII start up and process preparations for FDA Pre-Approval Inspection for

• Authored multiple SOPs and training formats for the company

• Analyzed protocols for quality/accuracy and assisted in the execution of validation processes for Operational Qualifications and Performance Qualifications for FDA certification of equipment and processes.

• Responsible for the successful scale up of 500 Lt. Insulin batches to 3000 Lt. Batch

Plasma Production and Inventory Control Technician BAYER PHARMACEUTICALS

January 1982 to December 1996

• Responsible for all aspects of Plasma Production

• Ordered all Chemicals and Filters used in the facility

• Managed inventory control of all items

• Maintained inventory records viewed by the FDA and most aspects of the Warehouse operation’s

Education

Associates Degree in Operations

JOHNSTON COMMUNITY COLLEGE - Bethesda, MD

Skills

• Assembly

• Logistics

• Technical writing

• Cleanroom

• Supervising experience

• Packaging

• Lean Manufacturing

• Leadership

• Senior leadership

• Purchasing

• Profit & loss

• Root Cause Analysis

• Basic math

• Warehouse experience

• Production Management

• Materials management

• Process improvement

• Writing skills

• 5S

• CGMP

• Auditing

• Micrometer

• Cleaning

• Quality Inspection

• Laboratory experience

• Change Management

• Six Sigma

• OSHA

• Food processing

• Team Management

• Lean Six Sigma

• Kaizen

• Inventory control

• Quality audits

• Power BI

• Communication skills

• SAP

• Customer service

• Manufacturing

• Quality assurance

• Quality Management

• Manufacturing management

• Lean

• FDA regulations

Certifications and Licenses

Six Sigma Green Belt

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