Tequila Mason
Wilson,NC
Overview
14
14
years of professional experience
1
1
Certification
Work History
QC Batch Release/Data Reviewer
Pfzier
Rocky Mount, NC
01.2023 - Current
- Reviews data from physical and dimensional test of commodities, including visual evaluation
- Prioritizes data review and testing with guidance from Data Coordinator
- Assists in monitoring laboratory metrics associated with turnaround goals
- Reviews batches associated with parenteral manufacture and packaged product
- As needed, performs visual and dimensional inspections for incoming material commodities required for testing, performs the analysis, records data according to cGMPs, performs calculations and enters results into LIMS system
- Performs final batch disposition
- Review/Approve GMP documents to ensure quality attributes are met Provides support to assure lab safety-either through safe use of chemicals or recognition of hazards- and that the lab is compliant with DEA, FDA, OSHA, and ICH guidelines.
Quality Control Administration/Technical Writer
Novartis
Wilson, NC
03.2021 - 12.2022
- Data entry into Excel/LIMS/MODA
- Data review of logbooks and notebooks
- Maintain raw material retains and client drug substance retains
- Maintain current and expired standards
- Prepare kits for chemists to perform job duties
- Reconciliation of released kits.
- Manage deviation for investigation
- Implement CAPS's
- Maintains compliance with company policies, training requirements, cGMPs and safety standards
- Performs continuous reviews and follow-up on investigations to minimize overall product impact and ensure the timely disposition of product that is directly affected
- Follow up to ensure batch release process is not impacted by outstanding deviations
Quality Control Specialist (full-time)
Novartis
Wilson, NC
11.2018 - 03.2021
- Perform sampling, review and QA disposition of raw materials and consumables used for cGMP manufacturing
- Preparation of contract lab documentation, tracking of sample status and review of test results from contract or internal laboratories to support disposition
- Assures raw material sampling rooms, booths or areas are maintained according to cleanliness classification and in cGMP compliant state
- Perform site self-inspections
- Support site safety initiatives
- Train new employees on tasks.
Quality Control Specialist (contractor)
Novartis
Wilson, NC
05.2018 - 11.2018
- Perform sampling, review and QA disposition of raw materials and consumables used for cGMP manufacturing
- Preparation of contract lab documentation, tracking of sample status and review of test results from contract or internal laboratories to support disposition
- Assures raw material sampling rooms, booths or areas are maintained according to cleanliness classification and in cGMP compliant state.
Quality Specialist/Batch Release
Merck Pharmaceuticals
03.2016 - 04.2018
- Batch Record Review
- Audits of laboratory data
- Complete activities for all data to ensure no errors.
Quality Control Specialist II
Hospira
11.2012 - 05.2015
- Visual/Dimensional inspections of glass vials
- Label and package acceptable units to be shipped.
Inspector
Merck Pharmaceuticals
02.2010 - 11.2012
- Start up machine/line
- Maintain 5s environment
- Cleanup/change-over, equipment operation.
Education
High School Diploma -
Wilson Technical Community College
Skills
- Quality Assurance
- Quality Inspector
- Quality Control
- Inspection
- Micrometer
- QA
- A S9100
- Trackwise
- Caliper
- 5S
- ISO 9001
- Manufacturing
- CGMP
- FDA regulations
- Laboratory experience
- Documentation review
- Filing
- AS400
- LIMS/GLIMS
- SAP
- GMP
Certification
- Med Tech certificate (Wilson Community College)
- Driver's License
Work Authorization
Authorized to work in the US for any employer
Timeline
QC Batch Release/Data Reviewer
Pfzier
01.2023 - Current
Quality Control Administration/Technical Writer
Novartis
03.2021 - 12.2022
Quality Control Specialist (full-time)
Novartis
11.2018 - 03.2021
Quality Control Specialist (contractor)
Novartis
05.2018 - 11.2018
Quality Specialist/Batch Release
Merck Pharmaceuticals
03.2016 - 04.2018
Quality Control Specialist II
Hospira
11.2012 - 05.2015
Inspector
Merck Pharmaceuticals
02.2010 - 11.2012
High School Diploma -
Wilson Technical Community College
- Med Tech certificate (Wilson Community College)
- Driver's License