Tracy Neal
Lucama
Summary
Quality assurance professional known for high standards and consistent results. Extensive experience in identifying and resolving quality issues to maintain top-tier product standards. Reliable team player with focus on collaboration and adapting to evolving project needs. Proficient in quality control processes and detail-oriented analysis.
Overview
27
27
years of professional experience
Work History
Quality Assurance Specialist
Merck Inc.
11.2015 - Current
- Executes batch record review and batch disposition activities for intermediate and finished good materials by use of SAP and MES systems
- Serve as QMS/Site Function 3.6 batch disposition topic lead
- Interact with the batch disposition QMS Topic owner and serve as a member of the Knowledge Network/Community of Practice to ensure product release is in alignment with global requirements
- Bring knowledge of the 3.6 Batch Disposition topic back to the site to facilitate and drive compliance and continuous improvement activities
- Provides Quality Assurance leadership and direction in implementing processes, procedures, and systems at the site
- Participate in internal, divisional, and regulatory audits and inspections
- Works independently with minimal guidance
- Acts as team lead and resource for colleagues
- Provided regular updates to team leadership on quality metrics by communicating consistency problems or production deficiencies.
- Ensured product compliance with industry regulations by staying up-to-date on relevant standards and guidelines, implementing necessary changes to maintain conformance.
- Authors, revise, review and implement local procedures to meet product quality standards.
Quality Assurance Specialist Associate
Merck Inc.
07.2006 - 11.2015
- Perform batch record review and finished product release utilizing the SAP system
- Work with members of Quality Assurance to identify and implement best practices that aid in streamlining the finished goods review and release processes
- Served as the Quality Representative for the daily Vaccine Tier meetings and Vaccine Batch Release Subject Matter Expert
- Perform defect resolution, batch record documentation resolution, and apply controls to material when appropriate
- Provide Quality Assurance review and approval of GMP related Standard Operating Procedures
- Train Quality Personnel on the batch record review and release processes
- Documented investigations and identified corrective actions as specified by Standard Operating Procedures
- Developed a Training Program for batch record review and release personnel
- Created a job aid to facilitate ease of floor support respondence and resolution
- Support Regulatory Inspections/Audits
Production Maintenance Administrative Specialist
Merck Inc.
02.2006 - 07.2006
- Formatted and Modified Standard Operating Procedure documents for review by the assigned approvers
- Routed Standard Operating Procedures for approval and signatures in a timely fashion to ensure appropriate time for training prior to the effective date of the procedure
- Tracked and managed CAPA due dates to ensure deadlines were adhered to
- Maintained Maintenance budget and expense records
- Reviewed and resolved documentation issues for Maintenance Work Orders
Packaging Operator
Merck Inc.
02.1998 - 02.2006
- Operated blister and bottle line machinery for packaging of finished goods
- Verified and assisted in the audit of production documents
- Team lead and trainer for production line activities
Education
B.S. - Business Administration
Barton College
Skills
- Microsoft Office
- Detail-oriented
- Quality Assurance
- Problem-solving skills
- Decision-making
- Cross Functional Team collaborator
- Customer service
- Quality improvements
- Team leadership
- Regulatory and Internal audits/inspections
Timeline
Quality Assurance Specialist
Merck Inc.
11.2015 - Current
Quality Assurance Specialist Associate
Merck Inc.
07.2006 - 11.2015
Production Maintenance Administrative Specialist
Merck Inc.
02.2006 - 07.2006
Packaging Operator
Merck Inc.
02.1998 - 02.2006
B.S. - Business Administration
Barton College
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