John Berga Email & Phone Number

Largo, Florida, United States

Largo, FL

Lakeland, Florida Area

Document Control Technician responsible for all document change control processes including but not limited to change order issuance and implementation. Overseeing the governing policies and procedures that pertain to change control/document control. Use of EDMS and/or manual system for the identification, traceability and implementation of all document.

• Archivist located at the Research and Development Unit charged with record retention, paper file and electronic file, for all Design History Files and Renal Protocols. All records retained per FDA Regulation per 21 CFR.
• Lowered average processing time for all archiving records from 12 days to 2 days as required by Quality Management within the first month of employment.
• Retrained all Product Lifecycle Management Authors to current standards within 2 months of employment.
• Wrote SOP’s for both Archiving and Record Retention Processes within the 4 months of employment.

• Tasked with management and training of all documentation employees at all levels of expertise. Document Author/Owner for Off-Site Storage, Record Retention and Good Documentation Practices for all of Tampa Bay.
• Bridged gap of communication between QDC and Research/Development Functional Groups within first week of employment by enhancing process by which approvers approve local document changes.

• Team lead for 3 separate groups of FCA Associates in 3 company locations. Tracked and Reported status of all U.S. Region FCA’s to local Quality Management and Corporate FCA Office in McGaw Park, IL.
• To receive the Team Lead Position I organized a process that allowed the FCA Associates the ability to clearly define and finalize a FCA that had been in process for 4 years and closed the FCA by the internal target.
• Successfully organized and executed a FCA alone and closed the FCA within the target timeline of the company and the FDA.

• Team Manager/Mentor tasked to coach and develop 22 agents within Customer Relations. Developed, tested and implemented Training Curriculum/Special Project for Customer Relations Department for Mobile, AL and Austin, TX.
• Within 1 year of employment, sales of the customer relations team was improved by 107% over previous years sales figures.

• Tasked with training all new hire Quality Control Inspectors on second shift operation of all areas in the manufacturing plant. Teamwork building between Engineering, Quality and Production. Developing, writing and.
• Within 6 months of employment, mentored QC Inspectors to be within Quality Management standards and requirements for percentage of errors.
• Within 12 months of employment, taken on 10 more trainee QC Inspectors straight from classroom training and integrated them into the manufacturing plant with inspectors that had been identified as training QC Inspectors.