Katina Maiz Brown
Charlotte,NC
Summary
Highly motivated Quality Assurance professional with 20-plus years in the pharmaceutical manufacturing industry. The ability to troubleshoot compliance issues in a fast-paced environment, with minimum supervision. Strong verbal, written, and listening skills to communicate with internal and external customers to solve problems and achieve goals. Also ensuring that products meet quality standards before they are shipped.
Overview
23
23
years of professional experience
Work History
QA Auditor & Doc
Prinston Labatories.
Charlotte, NC
02.2018 - Current
- Issue and control, but not limited to, Master Batch Records, Controlled Forms, Logbooks, Test Methods, Protocols, and Reports
- Assist in scanning all batch records, validation documentation, and supporting documentation
- Provides support during inspections and audits
- Organize and maintain the storage of electronic storage of cGMP documents
- Use and manage Quality spreadsheets, tracking sheets, and checklist
- Perform audit of issued controlled Master Batch Records for manufacturing and packaging to finalize reconciliation and ensure timely return of documents for final archival
Quality Assurance Inspector Label Room
Ei- Pharmaceutical SolutionWorks.
Landis, NC
11.2017 - 02.2018
- Physically stores new, reconciled labels in designated locations in the read, understand, and follow SOP and GMP guidelines
- Receive printed supply returns from packaging lines and processes for work order close out and return to the label room
- Responsible for keeping up with the weekly schedule pulled, and keeping up with the Labeling Inventory reconciliation records
- Make sure that all Process Pro transactions are entered and logged into the proper folders
- Visual inspection to determine such as ghosting, streaks, picks, and any defects
Quality Assurance Technician II
Qualitest/Par Pharmaceutical Inc.
Charlotte, NC
12.2008 - 12.2016
- Perform a final quality audit on manufacturing, packaging records, and analytical testing documentation
- Perform real-time internal audits, under the FDA Internal Audit Readiness team
- Participate with in-process improvement initiatives, Non-Conformance teams, and Kaizen Events
- Perform in-process audits to identify adherence to SOPs and BPR requirements
- Notify manufacturing or packaging of issues that may result in further investigation
- Review of Non-conformance reports for accuracy and provide feedback to authors
Quality Inspector I
Qualitest/Par Pharmaceutical Inc.
Charlotte, NC
12.2008 - 12.2016
- On-the-floor Quality Assurance oversights of manufacturing operations (weighing, blending, granulation, compression, and coating)
- Inspection of in-process and finished product samples
- Respond to and escalate events in real-time
- Issue batch records, and logbooks to departments
Quality Assurance Inspector
Leiner Health Products Inc.
Fort Mill, SC
08.2001 - 08.2007
- Quality Assurance verification of raw materials received for over-the-counter medications, and nutritional supplements.
- Testing of powders, coating solutions, dyes, liquids, flavors, and coloring, along with identification testing of raw materials, utilizing a laser spectrometer.
- Testing of the bulk products received for repackaging includes visual inspections for physical defects.
- Utilized micrometers to inspect the size and thickness of the product, as well as the analysis of color and proper identification according to the Certificate of Analysis.
- Authorized to release or reject products based on quality specifications. Assisted the manager, supervisor, and quality control lead with sampling, projects, and non-conformance investigations to determine the causes of quality issues and solutions.
Education
High School Diploma -
Northwestern High School
Rock Hill, SC06-1997
Skills
- Forklift
- MSDS
- CGMP
- SAP
- LIMS
- Trackwise
- Master Control
Timeline
QA Auditor & Doc
Prinston Labatories.
02.2018 - Current
Quality Assurance Inspector Label Room
Ei- Pharmaceutical SolutionWorks.
11.2017 - 02.2018
Quality Assurance Technician II
Qualitest/Par Pharmaceutical Inc.
12.2008 - 12.2016
Quality Inspector I
Qualitest/Par Pharmaceutical Inc.
12.2008 - 12.2016
Quality Assurance Inspector
Leiner Health Products Inc.
08.2001 - 08.2007
High School Diploma -
Northwestern High School
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