Quality Assurance Management

Leonard McCalop, Jr.

**** ******** **** *****

Raleigh, NC 27616

Phone: 919-***-****

Email:**************@*****.***

OBJECTIVE:

Seeking a challenging position which incorporates leadership through

teamwork, people growth and fosters innovation.

SUMMARY

Over 15 years of experience within the pharmaceutical

manufacturing/packaging arena. Skills include: extensive team

leading/supervisory skills; Leadership, knowledge of cGMPs, CFR and OSHA.

Problem solver, oral and written communication skills. Enthusiastic

organizational skills and ability to manage people/projects. Innovative,

detailed and team-oriented. Ability to perform multiple tasks, recommend

and implement solutions. Knowledge of production schedule deadlines.

Interviewing skills and recommend potential candidate. Ability to assist in

quality improvements and implement cost effective solutions. Valued team-

member for line and process validations. Experienced in ERP (JD Edwards

and SAP). Mechanically inclined and highly motivated with a concentrated

learning curve.

PROFESSIONAL EXPERIENCE:

Glaxosmithkline (GSK) contract position

July 2013-Oct 2013

Global Demand and Supply (GDS) Packaging and Labeling Operator

. Must assure clinical trial materials (CTMs) are produced in accordance

with clinical protocol to achieve useful results.

. Participates in the training of operations staff on procedures,

equipment operation, EOPs, and SOPs.

. Supports development and assists in the implementation of improvements to

documentation, SOP's, and policies, governing multiple areas, including

other departments and companies. Maintain the highest professional

standards. Keep management informed.

Synthon Pharmaceuticals, Inc. Feb 2012 -

Sep 2012

Packaging Supervisor

. Responsible for overseeing the daily operations of Packaging and

Warehouse operations, scheduled all packaging production runs and

packaging line testing.

. Ensured compliance through adherence of SOPs and company policies

relating to quality, safety, housekeeping and cost effectiveness.

. Assisted in maintaining 100% accurate inventory of DEA class 4 drugs

from the time the drugs were received in to the time they were shipped

to the customer.

. Responsible for overseeing and assisted the packaging and warehouse

operators in cleanliness and sanitization of assigned areas to meet

appropriate clean room or cGMP standards as needed.

. Partnered with QA in investigating all departmental deviations and

CAPAs.

. Responsible for written documentation relative to all departmental

procedures in Synthon Agile and eDoc systems approval.

. Executed departmental audits and generated efficiency records for

production (run time, downtime, and on time deliverables).

. Interviewed personnel for open positions within the department,

performed disciplinary tasks as needed.

. Facilitated departmental meetings.

Synthon Pharmaceuticals, Inc

May 2011 - Feb 2012

Packaging Coordinator

. Schedule batches for the production.

. Created and assigned packaging batch records and lot case label disks.

. Communicate with multiple departments on acquiring resources to

complete the packaging schedule.

. Approve documents through Synthon Agile and eDoc systems.

. Fill in and made decisions for the Packaging Director and Supervisor

when the packaging department was temporary without a director or

supervisor.

. Schedule packaging operators time-off.

Synthon Pharmaceuticals, Inc May 2007-

May 2011

Team Leader Packaging

. Assigned personnel to specific jobs and monitored personnel to meet

the daily production schedule.

. Ensured material and documentation needed to meet daily schedule were

available.

. Demonstrated task proficiency on all stations/levels within several

processes and assisted by operating equipment when needed to meet

production schedule.

. Troubleshot and performed root cause analysis and coordinated process

improvement efforts, cycle time reductions, waste reduction, and

streamlined processes.

. Monitored and supported all manufacturing operations for compliance

within applicable regulations-DEA, FDA, and OSHA. Ensured all cGMP

processes were performed according to written procedures.

. Trained each operator on all packaging equipment on the packaging

line -Cremer filler, NJM/ CLI labeler, Retorquer, Capper, bottle

unscrambler and case packer as well as the packaging line change-

over.

. Packaging line changeover consist of changing the packaging line

equipment over to run different products/ bottle configuration and

size if needed, disassembling and re-assembling the filler for

cleaning product contact parts and lubing some parts, cleaning the

rest of the packaging equipment and lubing any equipment if needed .

. Performed and assisted the operator in troubleshooting the packaging

equipment when a piece of equipment was not performing correctly.

. Wrote the departmental training documentations -SOPs for specific

tasks being performed, wrote clear and concise instructions and

performed periodic logbook audits. Received and facilitated continuous

training on all procedures within and across processes and regularly

reviewed written training documentation to verify documentation was

current and accurate.

. Performed assigned tasks to meet daily production schedule and

operated at a functional level with light supervision.

. Completed production reporting, transactions and planned production

and tracked production activities using the inventory management

system.

Eisai, Inc Jun 2002-

Apr 2007

Packaging Line Leader

. Responsible for overseeing the daily operations of the high speed

bottle line, blister line and the slow speed bottle line. Gained

supervisory experienced when needed or at the absence of the current

supervisor.

. Proven and demonstrated knowledge of Good Manufacturing Practices

facility, packaging and shipment operations. Extensive pharmaceutical

manufacturing and packaging experience. Reviewed documentation for

accuracy.

. Communicated with management and team of coworkers and other

departmental personnel. Compiled and sent daily production matrix data

and activity reports to upper level management. Notified management

of any employee or safety related issues. Assisted in root cause

analysis and problem solving decision making.

. Facilitated daily preshift meetings with fellow coworkers.

. Knowledgeable and demonstrated Current Good Manufacturing Practices

and reviewed Standard Operating Procedures. Assured sensitive

information was safeguarded in a confidential manner. Assisted in the

validation of setup, bottle size and products. Interviewed candidates

for hire.

Eisai, Inc. May

2000-Jun 2002

Certified Equipment Operator/Trainer/Mentor

. Trained new and current employees on equipment. Ensured compliances

were met relative to SOP's. Maintained training records and

coordinated training activities. Focused on process and continuous

improvement initiatives.

. Generated reports and facilitated meetings. Ensured certification of

employees after successful completion of training. Mentored employees

in problem areas. Member of the New Speed Packaging Line team.

Researched vendors participated in US and Canadian on-site vendors for

purchase of equipment.

. Communicated with internal and external customers and worked on

projects.

. Operated and performed change over's, set up of packaging line

equipment. Performed some mechanical adjustments and manual duties.

. Supported team members and maintained operation of equipment in

accordance to SOPs.

. Comprehended and managed simplex and complex mechanical packaging

operations.

International Paper, Inc. Oct

1998-May 2000

Production Technician

. Responsible for maintaining operation of the Pope and Black Clawson

machines. Assisted in ensuring production schedules and goals were

met.

. Maintained quality assurance of material.

PFS Sales, Inc. Aug 1995-Oct

1998

Warehouse Manager/Truck Driver

. Responsible for the day to day operations of the warehouse. Accepted

receivables and shipped freight. Ensured inventory was accurate.

. Processed invoices. Participated in multifaceted projects. Maintained

warehouse in an organized manner.

Abbotts Laboratories Apr

1986-Jul 1995

IV Bag and Pouch Inspector/Palletizer Operator/Material Handler

. Responsible for inspecting IV solution bags for missing components,

correct volume of IV solution in a bag, and for contaminates in a bags

Responsible for the maintenance and operation of the Moen and Delkor

caseformers.

. Provided corrugated cases for final product packaging. Ensured

palletizer operated in a uniformed manner during the stretch wrap

process and maintained quality assurance. Material Handler-Responsible

for the manufacturing and overwrap pouches of IV solution bags.

Inspected maintained calculations and documentation and disposed of

reject bags. Operated a fork lift and propane truck.

EDUCATION:

Rocky Mount Senior High School, 1984

Classes-Making the transition from Staff to Supervisor

Management Skills for New Supervisors

ASSOCIATIONS:

American Management Association

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