Summary
Overview
Work History
Education
Skills
Accomplishments
Timeline
Generic

LISA BAUREKO

Jackson

Summary

Dynamic Senior Manager with extensive experience at Bristol-Myers Squibb, excelling in SAP S4 HANA and production scheduling. Proven track record in quality assurance and incident investigation, leading teams to achieve operational excellence. Adept at implementing Lean manufacturing techniques, driving significant process improvements while fostering a culture of safety and compliance.

Overview

39
39
years of professional experience

Work History

Senior Manager, CSO Packaging and Labeling

Bristol-Myers Squibb, Co.
New Brunswick
01.2009 - Current
  • Supervise hourly bargaining personnel in the packaging and labeling of clinical supplies, assuring the timeliness of supply preparation output against MPP targets. Ensures that supplies are prepared in accordance with Current Good Manufacturing Procedures and Departmental/Global Standard Operating Procedures.
  • Creates the weekly finite production schedule.
  • Using SAP PI sheets, delivers a body of evidence (batch records) that supports the release of finished packaged supplies for clinical use. Reviews all completed shop floor PI sheets assuring their accuracy and completeness.
  • Liaises as required with Quality Assurance in order to resolve quality related events.
  • Developed the knowledge and functional expertise required to assume role of Subject Matter Expert in SAP driven PPI Production Process (e-Batch). Responsible for updating and testing (UAT) of master recipes.
  • P&L NB Lead for SAP S4 HANA Upgrade. Wrote production scripts and executed UAT (user acceptance testing) testing that supported the S/4Hanna functional changes.
  • Completed Kepner Tregoe Problem Solving and Decision Making training. As a qualified investigator responsible for issuing 'Alert Notices' and 'Incident Reports' and investigating incidents and instituting corrective actions in collaboration with Quality Assurance.
  • Responsible for the cleaning verification of product contact parts.
  • Trained in Prisym Clinical label printing software.
  • Assisted production team activities responsible for instituting the preparation of Syringe device combo products; a total of three new syringe (drug) devices were produced (Physioject Autoinjector, SSI and Ypsomate Auto injectors).
  • Appointed to represent NBR Packaging and Labeling team on the Orion Team. (New Electronic Batch record creation.
  • Creates Master Batch Recipes utilizing XStep Functionality

Supervisor, Sterile Filling & Supervisor of Environmental Monitoring

Bristol-Myers Squibb, Co.
01.1996 - 01.2001
  • Ensure that all filling and packaging processes and procedures are followed, adhering to strict SOPs.
  • Supervise hourly bargaining personnel, provide safety and job function training.
  • Plan and schedule weekly operations. Maintain a variety of production records.
  • Monitor the environmental area to ensure that all processes and procedures are followed adhering to strict SOP guideline.
  • Prepared monthly reports to capture all viable monitoring.
  • Respond efficiently and effectively to adverse environmental occurrences.
  • Maintain environmental and safety records.
  • Prepare and present safety and GMP training for all department employees.

Supervisor, Materials Management - Technical Operations

Bristol-Myers Squibb, Co.
01.1986 - 01.1996
  • Received and distributed raw materials in support of the manufacturing operation in an accurate and timely fashion.
  • Supervised the receiving and shipping operation (up to six hourly employees).
  • Supervised raw material inventory valued at $2 million.
  • Managed the department safety function.

CSO Production Coordinator- Packaging and Labeling

Bristol-Myers Squibb, Co.
  • Supervise hourly bargaining personnel in the packaging and labeling of clinical supplies. Ensures that supplies are prepared in accordance with Current Good Manufacturing Procedures and Departmental/Global Standard Operating Procedures.
  • Point person for cleaning verification within CSO P&L.
  • Authored or revised Departmental Procedural Documents (SOP’s and WI’s) as required.
  • Performed UAT scripts for the implementation of E-batch II.
  • Trained in ClinPro clinical label printing software.
  • CSO Safety Team Chair - scheduled safety meetings and addressed safety concerns.
  • Participated Kaizen event on the automated bottle filling operation - Through utilization of Lean techniques, operational process improvements were identified and implemented.

Education

Some College (No Degree) -

Middlesex County College
Edison, NJ

Skills

  • SAP S4 HANA
  • Manufacturing practices
  • Production scheduling
  • Environmental monitoring
  • Batch management
  • Quality assurance
  • Incident investigation
  • Lean manufacturing
  • Master batch recipes
  • Project management
  • Safety training

Accomplishments

P&L NB Lead for SAP S4 HANA Upgrade., P&L NB lead for the integration of Orion., P&L lead for cleaning verification., Lead the successful transition of parenteral inspection from PAR group to P&L., Assumed role of Subject Matter Expert in SAP driven PPI Production Process (e-Batch). Responsible for updating and testing (UAT) of master recipes., Qualified Investigator., Trained in the manufacturing of 3 device combo (syringe) products., Appointed to serve as the New Brunswick site Company Safety Committee Representative., Integrated two software systems that assured Y2K compliance and prevented the loss or inaccuracy of production records. Recipient of 'On the Spot' award for this project., Prepared the New Brunswick edition of the company-wide Tech Ops Division Safety Newsletter. Interacted with headquarters editorial professionals providing technical input for a published editorial on Intra-Net website., Insured the highest environmental standards, working with Quality Assurance and Microbiology., As a team member, worked on projects that reduced personnel and overtime., As a team member, developed strategies that reduced waste and down time leading to increase production.

Timeline

Senior Manager, CSO Packaging and Labeling

Bristol-Myers Squibb, Co.
01.2009 - Current

Supervisor, Sterile Filling & Supervisor of Environmental Monitoring

Bristol-Myers Squibb, Co.
01.1996 - 01.2001

Supervisor, Materials Management - Technical Operations

Bristol-Myers Squibb, Co.
01.1986 - 01.1996

CSO Production Coordinator- Packaging and Labeling

Bristol-Myers Squibb, Co.

Some College (No Degree) -

Middlesex County College

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