Allyson Perz
Pensacola,FL
Summary
Determined Quality Assurance Specialist with dedication to quality and accuracy. Familiar with handling multiple projects in highly competitive environments. Solid interpersonal and collaboration skills.
Overview
10
10
years of professional experience
Work History
Quality Assurance Specialist III/Trainer
Pegasus Laboratories
09.2022 - Current
- Manage customer complaint system, including receipt and investigation of adverse drug events and product defect reports, assess cases for to determine eligibility as 3-day 1932 field alert reports for complaints regarding product quality complaints, providing full complaint investigation reports including root cause for 1932 report submission to FDA, Health Canada, EU, and Japan, continued monitoring and trending of complaints and initiation of CAPA when needed
- Manage the CAPA system including initiation, review, and analysis of investigation reports, and tracking of investigations in accordance with internal procedures as well as any regulatory requirements
- Perform Annual Product Reviews for registered drug products
- Administrator of the cGMP Training system where primary duties include maintenance of training curricula via an electronic documentation system, perform annual curriculum review for each department, provide onboarding cGMP training, and perform annual cGMP training for all employees
- Develop and implement new training materials in response to company needs, changing regulatory requirements and advanced or updated technical skills requirements
- Assess all change controls for training requirements
- 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.
- Configuration and implementation of MasterControl electronic documentation system
Validation Scientist
Pegasus Laboratories
01.2020 - 09.2022
- Development of validation rationale in support of new product launch, post approval changes, and post validation verification activities using a science and risk-based approach
- Supported manufacturing scale-up efforts by providing technical expertise in the area of process validation.
- Support CMC with review of submissions for technical accuracy and provide scientific rationale and justification for post approval changes
- Provide key validation elements and identify critical process parameters in support of CMC submissions in addition to process design with particular attention to CPPs and CQAs during scale up
- Using control charting technique as an investigational tool for monitoring process capability as part of Stage 3 (continued process verification) of product process lifecycle in accordance with current ICH and FDA guidance
- Application of risk assessment approach to problem solving for both validation and commercial operations to understanding of process variability to reduce defects
- Development and maintenance of Product Validation Master Plans
- Maintain the Cleaning Validation system ensuring compliance with current cGMP, FDA, and EU regulatory requirements
- Conducting and writing investigations for unplanned and planned deviations in production processes and support of CAPAs where Technical Services input was merited
- Support Formulations through identification of acceptable excipient raw material substitutes and leading these projects from reformulation through the commercialization process
- Supported manufacturing scale-up efforts by providing technical expertise in the area of process validation
Validation Specialist
Pegasus Laboratories
10.2017 - 12.2019
- Writing and executing proceed validation, cleaning validation, and equipment installation/operation qualification protocols
- Writing standard operating procedures for new equipment
- Writing validation summary reports for all drug products as part of the APR process
- Supporting Operations through system investigation reports for planned and unplanned deviations in production processes
- Coordinating with Operations and the QC Laboratory to execute process and cleaning validations.
- Conducted thorough root cause analyses to address deviations during validation activities, implementing corrective actions as needed.
Analytical Chemist I
Pegasus Laboratories
02.2016 - 10.2017
- GMP/GLP Laboratory work in the Quality Control department working on Finished Goods produced for pharmaceutical use
- Testing of manufactured products and samples in support of stability studies
- Maintenance and calibration of equipment used during testing to ensure compliance with FDA regulations ensuring product quality
- Maintaining the Reference Standard system used by both Quality Control and Technical Services laboratory
- Reviewing and revising SOPs through the change control process
- Performed calculation spreadsheet validation.
Forensic Biologist Trainee
Trinity DNA Solutions
01.2015 - 01.2016
Forensic Technologist
Trinity DNA Solutions
01.2014 - 01.2015
Education
M.S. Biology -
University of West Florida
01.2014
B.S. Biology/Plant Science -
University of West Florida
01.2007
Skills
- Detail Oriented
- Quality Assurance
- Analytical Thinking
- Problem-solving skills
- Decision-Making
- Team Collaboration
- Quality improvements
- Quality Management Systems
Specialized Training
- KENX Cleanroom Qualification, Disinfection, and Environmental Monitoring April 2022
- KENX Validation & GMP University August 2020
- IVT Network Cleaning Validation August 2019
- ASQ Course: SPC Comprehensive Online 2019
- ASQ Course: Variation and Control Charts 2019
- ASQ Course: Process Capability 2019
Timeline
Quality Assurance Specialist III/Trainer
Pegasus Laboratories
09.2022 - Current
Validation Scientist
Pegasus Laboratories
01.2020 - 09.2022
Validation Specialist
Pegasus Laboratories
10.2017 - 12.2019
Analytical Chemist I
Pegasus Laboratories
02.2016 - 10.2017
Forensic Biologist Trainee
Trinity DNA Solutions
01.2015 - 01.2016
Forensic Technologist
Trinity DNA Solutions
01.2014 - 01.2015
M.S. Biology -
University of West Florida
B.S. Biology/Plant Science -
University of West Florida
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