Quality Control Manufacturing

J ames Bullard

********@**********.*** Cell: 727-***-****

S ummary Statement:

Experienced and proven manufacturing supervisor and trainer with 20 years in the

pharmaceutical industry. Supervised departments of 25+ associates, building effective and

efficient teams. Published author with wide experience in SOP creation/revision.

Accomplishments:

• Worked on the New Drug Application (NDA) team that produced a new formulation of Levoxyl in 2001

• Honors: Revamping the training structure throughout the facility which improved efficiency, eliminated training

gaps and improved documentation. Creation of SOPs covering all facets of several pieces of new equipment.

• Authored over 75 SOPs used by the entire plant as well as ones exclusively by my department.

• Conducted safety audits to hold plant to OSHA standards, achieving a 6-year span with no OSHA recordables.

• During an audit, found a production labeling error that would have caused a recall of several batches of product,

saving the company more than $1 million – plus untold potential public relations concerns.

• Worked on many Cross-Function Investigation (CFI) teams to devise CAPA when problems occurred in the

facility.

• Worked on a variety of successful Lean Manufacturing/Six Sigma projects.

• Led the winning team in visualization project within first 3 months at Transitions Optical.

• Successfully led and completed 2 projects at Transitions: Upgrades of Stamper machines and 5-S.

Experience:

2013 – 2014 Compounder/Aseptic Prep, Bausch+Lomb (Kelly Services), Tampa, FL

• Trained in the cleaning, operation and set-up of a variety of production equipment, including

SIP/CIP cleaning skids.

• Blended various eye care solutions according to recipes

2013 Manufacturing Supervisor, Transitions Optical Inc., Pinellas Park, FL

• Supervised a combination of operators and temporary employees (total: 7-12). This included

overseeing discipline, training and implementation of management initiatives.

• Scheduling personnel

• Used Eco-Time software to manage payroll

• Used various MS Office software to monitor production performance levels and evaluate operators

• Active member of the Manufacturing Leadership Team (MLT)

• Maintained product quality by enforcing company standards

• Maintained safe and clean environment with regular audits.

1995 - 2012 Manufacturing Lead, Pfizer Pharmaceuticals, Inc., St. Petersburg, FL

• Began as production associate, and then became Quality Control and Shift Lead.

• Personnel scheduling and input into production scheduling

• Lead trainer in plant, overseeing training of over 100 associates

• Writing, editing and updating of Standard Operating Procedures throughout the company.

• Set-up, operate, troubleshoot and clean a wide variety of production machines, including high speed

tablet presses and in-process testing equipment.

• Production preparations, Final Sign-Offs and auditing of batch records.

• Conducting and writing investigations for failure and other events in manufacturing.

• Technical repair and maintenance of tablet presses.

• Maintained product quality by enforcing company standards/SOPs.

• Member: Plant Safety and Events committees. Trained First Responder

Specialized knowledge: Documentum system, cGMP, OSHA and FDA rules/regulations.

Education: Bachelor’s Degree, University of South Florida

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