Dustin Garlette
Easton,Pennsylvania
Summary
Experienced and determined Quality Assurance Supervisor with over 10 years in the Pharmaceutical industry with a dedication to quality and accuracy. Familiar with handling multiple projects in highly competitive environments. Solid interpersonal and collaboration skills. Outstanding communication, organizational and time management talents.
Overview
10
10
years of professional experience
Work History
Supervisor, Quality Assurance
QuVa Pharma
09.2020 - Current
- Oversees failure and discrepancy investigations and documenting investigations on process deviations or equipment malfunctions
- Provides written reports to senior management on a timely basis in conjunction with the appropriate documentation to deliver assurance that all operations and procedures were practiced in a compliant manner
- Supervises all areas requiring Manufacturing QA oversight including Aseptic Compounding, Inspection Labeling and Packaging, Warehouse operations, batch record review, equipment calibration, analysis of trends, and operating procedures
- Implemented a Visual Inspection Defect Challenge Qualification program utilized by all QuVa Pharma facilities performing visual inspection activities
- Experienced with building defects fit for use with a defect challenge set, including the implementation of protocols validating the probability of detection for particulate and other container defects
- Develops and provides oversight to identification and implementation of appropriate corrective actions and preventive actions
- Reviews routine manufacturing, environmental monitoring and quality control data for in-process and finished products
- Provides consistent oversight of the environmental monitoring program, including appropriate escalation of environmental and personnel monitoring results that exceed alert or action limits and interpreting results
- Responsible for timely and accurate disposition of finished product to assure each batch meets specification prior to release
- Periodically review records to verify that quality standards for each drug product is met
- Ensures and maintains site wide compliance with FDA 503B and cGMP guidelines / state and federal laws
- Responsible to maintain all testing equipment in compliance, calibration and certification
- Assists in developing policies and procedures related to QA, Operations, and site wide compliance
- Promptly communicates with Operations regarding non-routine events, process deviations, product issues/variance
- Enforces applicable personnel policies, procedures, and ensures site wide compliance with all Aseptic Techniques, OSHA, cGMPs, Hazmat and all FDA regulations
- Supervises Quality Assurance staff on assigned shift
- Evaluation of batch records/product for compliance with defined specifications
- Ensure documents, procedures, and work instructions have the most current and up to date version at all times
- Perform gap analysis of all quality related procedures to ensure there are no gaps are present
- Generates appropriate workflows for creation, revisions, review, approval, and the implementation of procedures relating to corresponding forms, protocols, and batch records
- Ensures that all written procedures and changes are followed that impact the compounding process control design to assure that all compounded products will have the identity, strength, quality, and purity that they are represented to uphold
- Organized and facilitated EM PQs for the certification of Aseptic Processing Areas across multiple buildings between multiple QuVa Pharma locations with emphasis on process alignment between each site.
Lead, Quality Assurance Specialist
QuVa Pharma
07.2019 - 01.2020
- Verified that each area requiring QA staff had the required equipment/materials to support shift start without delay and resolved any issues that were identified to assure the shift start was on time
- Facilitate crew arrival to the assigned work stations in support of on-time shift start with the objective to have crew active on assigned jobs within the start of the shift without delay
- During daily huddles, stated key items to reinforce required daily shift performance such as procedural controls, work instructions, lessons learned from experience including
- Demonstrates a high level of independent judgment and discretion in the timely identification, investigation and resolution of events potentially impacting the Quality of products and processes
- Facilitates administration of controlled documents used for Quality functions
- Inspection and delivery of environmental samples, maintaining FDA sterility classifications, sterile processing and familiarity with aseptic process areas monitored by the Environmental Control Program
- Demonstrates a subject matter expert (SME) level of independent judgment and discretion in the timely identification, investigation, and resolution of any event potentially impacting the Quality of products and processes
- Showed excellent communication, interpersonal and organization skills
- Originated and proposed enhancements to better improve production efforts over obstacles to an above satisfactory completion
- Works independently to provide quality assurance oversight to all areas assigned in which the business is responsible for adhering to current Good Manufacturing Practices including warehouse functions, manufacturing processes, inspection, labeling and packaging, batch record review, disposition of batch records, cleanroom activities, and product distribution.
Quality Assurance Specialist - Quality Assurance
QuVa Pharma
07.2018 - 01.2019
- Performs site wide compliance to QuVa Pharma’s Standard Operating Procedures (SOPs) and Quality Management Systems
- Ensures all work is performed and documented in a timely manner and in compliance to all approved standard operating procedures and cGMPs
- Oversight of all retained sample storage and retrieval
- Regularly completed viable/non-viable air sampling, viable surface sampling, and weekly/monthly room sites in compliance with the Environmental Control Program under both dynamic and static conditions
- Assisted as a team member to maintain quality, integrity, and safety of the final product while operating in a controlled environment
- Ensures all compounded batches met the acceptable quality limit (AQL) through visual inspection, document and batch record review, and facilitating all corrections in communication with personnel/management prior to release
- Coordinates the assignment of procedure effective dates within all QuVa Pharma training departments.
Quality Technician - Quality Assurance
Central Admixture Pharmacy Services
07.2017 - 07.2018
- Responsible for ensuring and authorizing the approval/rejection of all compounded batches, drug product containers, closures, in-process ingredients, packaging ingredients, labeling, and drug products
- Tracked, reviewed, and approved out of specification investigations and compounding deviation investigations
- Responsible for retrieving environmental monitoring samples of IV technicians, Pharmacists, and sample any personnel in use of laminar flow clean air hoods and other contamination control devices
- Completed all necessary documentation relating to aseptic modules and iSOtrain qualifications
- Experience assembling data of environmental monitoring surface and air samples and submitting information as per Quality Assurance standard operating procedures
- Quality – deviation prevention.
Senior Pharmaceutical Technician - Filling
Sanofi Pasteur
06.2015 - 11.2016
- Quality Assurance experience assembling data of environmental monitoring plates and submitting information into the Sanofi Pasteur MASTER System/Pharmnet-Web and corresponding EM logbooks
- Regularly completed weekly and monthly site monitoring, including viable/non-viable and surface sampling under both dynamic and static conditions
- Completed alarm summary sheets for Pharmnet-Web and Data Management Systems Request (DMSR) forms to maintain proper good documentation practices
- Performed routine settle plate and end of process monitoring for Grade B Restricted Area Barrier Systems (RABS)
- Adhered to procedures in SOPs/SWIs, BFR’s, BPR’s and any other process documentation
- Performed as a line lead with attention to compliance and safety following SWI’s, SOP’s, FDA regulations, and cGMP’s with all production activities assigned in accordance to specifications
- Aseptic gown qualified as per Sanofi Pasteur requirements to operate in critical areas
- Performed the filling process under grade A/B classifications and was an operator of parenteral sterile filling
- Provided guidance and leadership when the supervisor was unavailable, communicated the status of operations to management in a timely manner
- Performed shift communications, HMI support, tracked daily production progress, and provided weekend coverage
- Complied with all Aseptic Techniques, OSHA, cGMPs, Hazmat and all FDA regulations.
Manufacturing Technician – Inspection
Sanofi Pasteur
09.2013 - 09.2014
- Inspected all products manufactured at the Swiftwater Campus by Sanofi Pasteur
- Completed all necessary documentation relating to aseptic modules and ISOtrain qualifications
- Contributed to final inspection by hand or on semi-automated inspection machines
- Followed procedures for the current SOPs/SWIs, BIR’s, BPR’s
- Adhered to current safety standards and requirements ensuring an injury free work environment in addition to protecting the efficacy and integrity of the product
- Tracked and documented time out of refrigeration (TORs) for all cold storage products
- Practiced cGMP’s to comply with deviation prevention and quality control
- Qualified in cleaning and disinfection of classified/unclassified areas.
Education
Northampton Community College
Tannersville, PennsylvaniaNo Degree - Liberal Arts And General Studies
Northampton Community College
Bethlehem, PAHigh School Diploma -
East Stroudsburg Area High School South
East Stroudsburg, PA06.2008
Skills
- Staff Management
- Regulatory Compliance
- Quality Assurance
- Sterilization Procedures/EM Sampling
- Process Improvement
- Documentation and Reporting
- Corrective Action Planning
- Technical Writing
Accomplishments
- Awarded the Margrit Roeckendorf Scholarship for Excellence in German
- Recipient of the East Stroudsburg Area High School South Language Award for German
Timeline
Supervisor, Quality Assurance
QuVa Pharma
09.2020 - Current
Lead, Quality Assurance Specialist
QuVa Pharma
07.2019 - 01.2020
Quality Assurance Specialist - Quality Assurance
QuVa Pharma
07.2018 - 01.2019
Quality Technician - Quality Assurance
Central Admixture Pharmacy Services
07.2017 - 07.2018
Senior Pharmaceutical Technician - Filling
Sanofi Pasteur
06.2015 - 11.2016
Manufacturing Technician – Inspection
Sanofi Pasteur
09.2013 - 09.2014
Northampton Community College
No Degree - Liberal Arts And General Studies
Northampton Community College
High School Diploma -
East Stroudsburg Area High School South