Brenda Laboy
Quality Assruance Manager
Emmaus,PA
Summary
ASQ Certified Six Sigma Green Belt and Certified Quality Process Analyst with Quality Management and cGMP experience in the pharmaceutical packaging industry. Seeking a position where my experience, skills, and training can be utilized.
Overview
6
6
years of professional experience
4
4
years of post-secondary education
6
6
Certifications
2
2
Languages
Work History
Quality Assurance Manager
Sharp Packaging Solutions (Allentown, PA)
02.2021 - Current
- Supervision of quality functions including three (3) shifts of employees, label production, in-process inspections and finished product inspections.
- Participation in internal, regulatory and customer audits and customer visits at discretion of management.
- Participation and follow-up on all customer audits and inspections specific to Sharp Allentown including assisting in audit responses and monitoring commitments specific to related areas in quality.
- Investigation of Non Conformances related to procedures, policies, specifications or protocols.
- Assist Quality Systems team with investigations for consumer complaints related to packaging that are received from customers specific to related areas.
- Review, revision, and establishment of Standard Operating Procedure (SOPs) and Work Instructions (WRKIs) on designated basis to ensure accuracy and compliance.
- Assist in appropriate problem solving initiatives to address customer or regulatory quality issues as requested by senior management.
- Oversight and documentation of training of floor staff to ensure job functions are clear.
- Management of Label Room and staff for creation and printing of labels and Batch Record preparation/printing prior to production.
- Ensured completion of Environmental Samples (Air Sampling and Water Testing) in compliance with Environmental Monitoring program.
- Ensured that quality equipment is in compliance with calibration program and reviewed Calibration Work Orders in Regulatory Asset Management System after completion of calibration to ensure compliance.
- Assistance with development of Master Packaging Records to compliance with accurate and traceable packaging processes
- Review and Approval of cGMP documents such as Change Control Request, Temporary Change Request, Bill of Materials, Master Packaging Records, Rework/Re-Inspection/ Redress Protocols, Training Modules, Serialized Master Data (SMD), and Serialized Connectivity Data (SCD) for accuracy and compliance to requirements.
- Review and approval of Supplier Non Conformance Records in conjunction with Procurement and/or Clients to disposition material related to Non Conformance Records (Components and Finished Goods).
- Cooperated with engineering, manufacturing and corporate accounting to verify adherence to quality standards.
- Tracked quality issues with external customers, suppliers and internal plant operations.
- Established and tracked quality department goals and objectives.
- Reported production malfunctions to managers and production supervisors
Quality Assurance Supervisor
Sharp Packaging Solutions (Allentown, PA)
10.2018 - 01.2021
- Direct supervision of Quality Assurance Inspectors
- Resolution of all issues pertaining to quality in production suites pausing production as required in conjunction with the Operations Department, Technical Manufacturing, and Engineering and contacting customers as required
- Oversight of scheduling of Quality Inspectors and Daily Manning
- Review and Approval ofGMP documents such as Change Control Request, Temporary Change Request, Bill of Materials, Master Packaging Records, Rework/Reinspection/ Redress Protocols
- Leading and participating in completion of investigation reports. This includes working with other internal departments on root cause analysis and assignment of applicable corrective/preventative actions.
- Issuance and closure of Non Conformance Records
- Participating in customer meetings to ensure all Quality issues are addressed for product release.
- Assist Batch Record Review Department with corrections and customer feedback
- Assistance with customer and internal audits as well as customer complaint investigations
- Assist Compliance Department with investigation of any inventory discrepancies for controlled substances and closure of associated event reports.
- Oversight and training of co-workers.
- Facilitation of Quality Supervisor Monthly Meetings
- Monitored equipment calibrations and facilitated calibrations with vendors. Purchasing of supplies for the department.
- Assessed investigation reports of subordinate quality assurance personnel and addressed any procedural deviations.
- Provided regular updates to team leadership on quality metrics by communicating consistency problems or production deficiencies.
- Oversaw onboarding and training of new employees to promote qualified and well-coordinated quality assurance team.
- Addressed non-conformance issues, pausing production to correct errors.
- Educated employees on specific QA standards and confirmed maintenance of standards.
- Monitored testing processes, test development and user acceptance testing.
Quality Assurance Lead (Acting)
Sharp Packaging Solutions (Allentown, PA)
05.2017 - 09.2018
- Scheduling of Quality Inspectors/Daily Manning
- Lead and mentor Quality Inspectors
- Facilitate and manage training progress of Quality Inspectors
- Issuance and completion of Non Conformance Records
- Review and approval of GMP documents such as Bill of Materials and Master Packaging Records
- Label printing
- Directed day-to-day quality assurance department activities, establishing rapport with team members to facilitate effective communication and coordination.
- Assist Batch Record Review department with corrections
- Guidance of Operations and Quality Teams to assess quality issues and mitigate potential risks.
- Investigated variances, performed root-cause analysis and documented corrective actions to resolve complications.
Quality Assurance Inspector
Sharp Packaging Solutions (Allentown, PA)
07.2016 - 05.2017
- Enforcement of cGMP compliance and that Standard Operational
- Procedures are being followed at all times
- Verification of documentation, room cleans, AQL sampling plans, equipment and incoming components
- Ensuring the proper execution of packing procedures aswell as completion and accuracy of finished goods in accordance to customer and FDA specified guidelines.
- Inspected quality of products, taking note of functionality, appearance and other specifications. Used calipers and micrometer measuring instruments.
- Storage and handling of controlled substances
- Work with internal staff to meet scheduling requirements in a timely manner.
- Identified where product issues were coming from and rectified issues.
Education
Bachelor of Science - Genetic And Developmental Biology
The Pennsylvania State University
Reading, PA 08.2012 - 05.2016
Louis E. Dieruff High School
Allentown, PA 09.2008 - 06.2012
Skills
Microsoft Office Suite
Certification
ASQ Certified Six Sigma Green Belt
References
Michele Snow Frederick
Quality Assruance Manager
610 653 4683
Xavier Sanchez
Project Manager
484 632 6077
Kathleen Bachman
Quality Assurance Manager
610 972 9959
Timeline
Quality Assurance Manager
Sharp Packaging Solutions (Allentown, PA)
02.2021 - Current
Quality Assurance Supervisor
Sharp Packaging Solutions (Allentown, PA)
10.2018 - 01.2021
Quality Assurance Lead (Acting)
Sharp Packaging Solutions (Allentown, PA)
05.2017 - 09.2018
Quality Assurance Inspector
Sharp Packaging Solutions (Allentown, PA)
07.2016 - 05.2017
Bachelor of Science - Genetic And Developmental Biology
The Pennsylvania State University
08.2012 - 05.2016
Louis E. Dieruff High School
09.2008 - 06.2012
ASQ Certified Six Sigma Green Belt
ASQ Certified Quality Process Analyst
Six Sigma LEAN 101
Adult and Pediatric First Aid/CPR/AED
Occupational Safety and Health Administration
Vaprox Hydrogen Peroxide Sterilent Applicator
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