Quality Control Ehs Coordinator

James Bullard

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

Summary Statement:

I am aproven hands-on manufacturing supervisor/trainer, Quality Control Supervisor/Inspectorand EHS coordinator with more than 30 years’ experience. My work has spanned from pharmaceuticals and nutritional products to circuit boards and machined parts.

Notable Accomplishments:

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

During a pharmaceutical audit, found a production labeling error that saved millions and prevented 4 recalls.

Authored or revised over 1000 SOPs/work instructionson a variety of topics, including safety.

Conducted EHS/safety audits to hold a plant a 6-year span with no OSHA recordables.

Earned awards for above audit while at Pfizer, revising documentation and training upgrades.

Worked on several Cross-Function Investigation (CFI) teams to devise CAPA.

Experience:

Ultra Pure Bottled Water, Tampa FL July 7, 2024 – Nov. 21, 2024

Manage personnel and resources for 2nd shift at the production plant to maintain efficiency and assure quality output and on-time delivery.

Hire, discipline, train, coach and fire employees as needed.

Perform performance reviews

Maintain 6S

Manage EHS duties for the shift

National Molding (First Team Staffing), Largo, FL May 13 – July 5, 2024

Conduct pre-, in- and post process inspections of areas and product to meet/exceed standards.

Clear room certified

Safety and Environmental Security Coordinator, Coca-Cola Company, Dunedin, FL Sept. 21, 2023 – April 5, 2024

Conduct safety and environmental audits on the facility.

Conduct incident investigations and draft reports.

Maintain spreadsheets to monitor safety trends.

Represent the department in corporate meetings, reporting on safety and environmental issues – and coordinate with outside regulatory agencies.

Conduct safety related training of all employees (including LOTO)

Help coordinate and run and conduct the ASC (safety team) meetings.

HAZWOPER, LOTO certified.

Clean Room Associate, AdvancedImpact Technologies, Largo, FL Aug. 1, 2023 – Sept. 20, 2023

Assembled, packaged, and inspected bullet-proof and safety glass per customer requirements.

Maintained clean room cleanliness and 6S status.

QC/Sanitation Supervisor, EHS Coordinator, Peak Nutritional Products, Tampa,FLJune 2022 – July 2023

Hired, supervised, and trained a two-shift team of 5+Quality Control Inspectors.

Conducted facility Quality and Safety audits– both in-process and post-process.

Created and revised SOPs, forms, and documentation via X-Docs

Built strong cleaning protocols and safety programs.

Conducted personnel reviews and created disciplinary actions as necessary with all departments.

Performing investigations (failures and events), developing CAPA as required.Quarantine items if needed.

Worked to roll-out and train on X-Docs, an electronic training/documentation system.

Machine Operator(temporary position), Madico, Pinellas Park, FL May 2022 – June 2022

Complete and audit batch records for errors/omissions.

Clean, operate and set up LC2 production line and perform in-process checks to maintain specifications.

Quality Control Inspector, Kramski (via Randstad), Clearwater, FL Feb. 28, 2022 – April 22, 2022

Conduct start-up, in-process, and final product inspection of machined parts.

Use of micrometers, Keyonce and Zeiss inspection equipment and comparators.

Computerized documentation of all checks and organization/storage of retains.

Ability to read blueprints.

Masker Coater, Jabil Defense and Aerospace, St. Petersburg, FL June 20, 2016 – Feb. 14, 2022

Prep circuit boards for coating process through de-masking boards for final assembly.

Manually coat and assemble circuit boards.

Operate a variety of coating, washing and drying machines.

Inspect parts/assemblies before moving onto next location.

Merchandiser, Coca Cola Beverages Florida, Tampa, FL May 2016 - July 2016

Restocked Coca Cola product lines throughout client stores

Developed, prepared, and built displays for marketing.

Manufacturing Administrative SpecialistI, CoreRx, Clearwater, FL July 2015 – Feb. 2016

Document Control duties. Generated and revised master batch records in pharmaceutical cGMP facility to meet client specifications.

Manufacturing training specialist. Worked on qualification, roll-out, implementation and training for X-Docs, an electronic training and documentation system.

Chemical Specialty Operator, TSE, Clearwater, FL Oct. 2014 – June 2015

Blended/packaged a variety of chemical compounds according to formulations in large scale chemical reactor tanks. Pulled samples and recorded in-process data and reconciliation information on batch records.

Weighed and dispensed all ingredients needed per various formulations.

Forklift certified.

Compounder and Aseptic Prep, Bausch + Lomb (via Kelly Services, Tampa, FL Oct. 2013 – June 2014

Used a variety of equipment and tools to blend solution and suspension products.

Aseptic Core certified

Prepped “kits” for manufacturing units inside and outside the aseptic core.

Ran sterilization equipment (autoclaves, dry heat chamber and CIP/SIP skids

Manufacturing Supervisor, Transitions Optical, Pinellas Park, FL Jan. – July 2013

Supervised 20 employees. Responsible for discipline, training, implementation of management initiatives.

Used Eco-Time software to manage payroll.

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

Active member of the Manufacturing Leadership Team (MLT) and safety team

Labeling and packaging.

Manufacturing Lead (end position), Pfizer Pharmaceuticals, Inc., St. Petersburg, FLJan. 1994 – Nov. 2012

Began as production associate, and then became Quality Control Inspector thenworking Shift Lead. As shift lead, cross-trained to act as lead on packaging lines and blending department.

Managed and training of all Compression Associates (17-25 associates)

Writing, editing, and updating of SOPs throughout the company.

Ability to set-up/operate/troubleshoot, repair/maintain,calibrate,and clean a wide variety of production machines, including high speed tablet presses, ribbon blenders and in-process testing equipment.

Production preparations/final Signoffs and auditing of batch records.

Conducting investigations for failure and other events in manufacturing.

Ran EHS/Plant Safety committee for years. Trained First Responder

Operated blending/compounding machines, packaging line components and labeling.

Specialized knowledge:

MS Office, X-Docs and Documentum systems, SAP, cGMP, OSHA, HAZWOPER, First Aid/CPR, Bloodborne pathogens and FDA rules/regulations. Worked on successful Lean Manufacturing, Six Sigma and 5S/6S projects.

Other Positions Held:

Retail Manager Your Name in Headline (St. Petersburg), PT

Retail Manager Sun Zone, St. Petersburg, FL

Editorial Assistant/Staff Writer St. Petersburg Times, St. Petersburg, FL (12 years)

Education:

Bachelor’s Degree, University of South Florida

AA, St. Petersburg College

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