Jazzva Watson
Memphis,TN
Overview
15
15
years of professional experience
4
4
years of post-secondary education
Work History
Manager, Biomanufacturing
Charles River Labs (CDMO)
Memphis
05.2023 - Current
- Oversee all activities related to the start-up and production of new and existing client processes in accordance with Charles River Labs quality and production timelines and agreements
- Schedule and manage manufacturing staff ensuring adherence to production schedule; coordinate with relevant functions to ensure schedule adherence
- Ensure a safe and compliant working environment by enforcing safety and quality policies and practices
- Communicate results, metrics improvements, and necessary escalations to Quality and other department area leaders and/or managers effectively
- Conduct, track and communicate training needs especially in support of Quality and Compliance
- Lead and collaborate with CAPA investigations and make clear recommendations for corrective actions based collaborative efforts and expertise
- Perform and conduct internal investigation support when deviations occur, drive root cause analysis and identification, analyze data to identify areas of improvement to drive deviations and non-conformances down
- Serve as manufacturing production representative on cross-functional teams ensuring on-time completion of deliverables related to operations, production, and disposition
- Advise and inform site and company leadership of issues with the potential to impact production timelines or Critical Quality Attributes of client products
- Participate in Regulatory, Quality, and Customer inspection and audits as manufacturing systems and production process SME
- Build, train and develop highly skilled production teams capable of producing cell therapy products in accordance with regulatory guidelines and CRL quality standards
- Oversee the drafting, review, and approval of process specific and Internal Quality Systems documents
- Review completed batch records at the conclusion of processing and provide final departmental signoff prior to submitting to QA specialists
- Reconcile all documents related to a batch lot to ensure all control documents are accounted for and archived properly
- Foster a culture of continuous improvement; identify opportunities and lead implementation of improvement activities as required
- Update internal department SOP and other documents (i.e
- Master batch records, protocols, Work Instructions, Specifications and labels) as needed
- Evaluate existing manufacturing and quality documentation and procedures to ensure compliance and accuracy
- Track Logbook issuance and resubmissions with internal tracking system for reconciliation and archival
- Ensure compliance with regulatory and legal requirements related to manufacturing processes, document control and safety standards
- Identify opportunities for process improvement, cost reduction, and waste elimination, and implement appropriate measures
- Ensure all work is performed and documented in accordance with cGMP requirements and standard operating procedures
- Assist and oversee manufacturing process in suite as needed
- Generate batch lot numbers in accordance to manufacturing production schedule.
Supervisor, Biomanufacturing
Charles River Labs (CDMO)
Memphis
09.2019 - 05.2023
- Responsible for the editing and maintenance of controlled documents including Standard Operating Procedures, Master Batch Records, Specifications, Protocols, and other miscellaneous documents
- Provide support for regulatory inspections and partner audits
- Ensure all work is performed and documented in accordance with cGMP requirements and standard operating procedures
- Oversees manufacturing personnel in equipment setup, operations, and processes in accordance with cGMPs, Cognate Quality systems, and process documents
- Conducts and schedules training for new employees, schedules personnel to support production related activities
- Provide assistance to management in the revision/writing of process documents to ensure accuracy and completeness
- Reviews BPRs and associated documentation for accuracy, compliance, and presence of all verification signatures
- Ensures employees understand duties, responsibilities, policies, and procedures
- Leads and implements continuous improvement activities and assists with projects as assigned
- Lead, monitor, and develop direct reports
- Streamline client processes for efficiency and productivity.
Lab Technician/ Specimen Processor
Idexx Laboratories
Memphis
04.2019 - 09.2019
- Receives and prepares animal specimen samples for laboratory analyses and testing that diagnose various pet illnesses, injuries and diseases
- Sorts and distributes samples to appropriate departments for testing and analyses
- Prepares samples on slides or other testing formats
- Records required information and sends to appropriate specialty lab area
- Enter data about the specimens into a computer tracking system
- Rack and bundle prepared samples for delivery to each testing department
- Assist lab personnel with specimen storage and ensuring turnaround times (TAT) are met.
Sterile IV compounding technician Lead
SCA Pharmeceuticals
Little Rock
07.2015 - 12.2018
- Performed, led and trained start up facility staff to become stable and completely compliant in my area of responsibility
- Prepared IV admixtures per client order, as well as batch compounding of routine items meeting 100% productivity and quality metrics
- Accurately document work performed at multiple stages in the process
- Participate and assist with line clearance activities
- Identify, communicate and solve problems to ensure quality, efficiency, and safety objectives are met
- Verify incoming materials for use for accuracy for compounding area
- Cross trained in the Micro Environmental testing department to assist with weekend sampling and reading of TSA touch plates as needed.
Quality Associate Supervisor – Clean Room
Pharmedium Healthcare Corporation
Memphis
06.2014 - 04.2015
- Coordinate with Pharmacists to resolve aseptic breach issues that arise during batch processing
- Supervise, schedule, and coordinate quality technicians daily work load
- Assist the Quality Supervisor with quality operations and responsibilities at the Pain Management facility
- Ensure 100% compliance to procedures and address non-compliance issues
- Conduct daily audits of the Main Clean Room and Clean Room Suites during production hours
- Provide live feedback to technicians and pharmacists when not in compliance with Facility SOP
- Assist in collection and compilation of data for submission of all DEA related reports
- Initiate and follow through on investigations for micro positives
- Perform review of quality related documents generated at the facility
- Collaborate with other members of the quality team to prep and oversee quality assurance projects in the clean room
- Construct spreadsheets for easy recording and retrieval of data
- Maintain accurate and complete documentation of processes and system records
- Complete follow ups with technicians and pharmacists in regards to missing information on batch record documentation
- Data entry and documentation of completed tests, batches, and ordered supplies
- Communicate with Pharmacists, managers, and technicians in a professional manner in accordance with quality guidelines
- Perform quality inspections on all drugs and material received for IV clean room use
- Maintain organized work space and an organized system of filing paperwork
- Assist microbiological technicians with daily sampling whenever necessary
- Use of equipment to obtain viable and non-viable particulate samples and readings, surface samples, and personnel sampling
- Documented and reported trends in sampling to quality department and clean room pharmacists.
Lead Compounding Pharmacy Technician (Clean Room)
Pharmedium Healthcare Corporation
Memphis
03.2012 - 06.2014
- Trained new technicians entering the clean room
- Communicate issues appropriately with lead pharmacists/ pharmacy manager and operation supervisors
- Assign batches to clean room technicians
- Assist in compounding IV preparations
- Verify documentation for completeness and accuracy
- Process special code/ special order batches
- Managed kanban for clean room supplies
- Ensured compliance of 5S within clean room through audits
- Validate final products for accurate fill volume and particulate matter
- Lead a team of 15 technicians that perform daily clean room functions
- Work with team pharmacist to ensure that the team follows SOP and aseptic technique at all times
- Verify and document expiration date of all materials used for compounding.
Compounding Pharmacy Technician (Clean Room)
Pharmedium Healthcare Corporation
Memphis
01.2011 - 03.2012
- Perform daily cleaning of work area and maintain organized work space
- Pool medications from vials and ampoules to pooling bags
- Prepare sterile IV admixture compounds
- Aseptically transfer sterile IV admixtures to final containers i.e
- Intravia bags, PCA vials, syringes
- Maintain inventory and supplies
- Verify stock and enter data into computer
- Perform documentation of IV preparations
- Receive and restock unused raw drug materials
- Packaging and labeling of products for bar code scanning and quality control.
Production Pharmacy Technician
Pharmedium Healthcare Corporation
Memphis
09.2009 - 01.2011
- Verify information of other technicians in regard to product documentation and packaging, inspect products for quality and document any defects in products
- Ensure that medication inventory is properly accounted for and properly stored in correct environment and location
- Assist in clean room and IV process when necessary
- Label final medical products for scanning and packaging
- Scan final products and prepare products for final shipment to customers
- Maintain neat and organized work area
- Perform daily cleaning of work area.
Summary
Talented Manager with expert team leadership, planning, and organizational skills built during successful career. Smoothly equip employees to independently handle daily functions and meet customer needs. Diligent trainer and mentor with exceptional management abilities and results-driven approach. Encouraging manager and analytical problem-solver with talents for team building, leading and motivating, as well as excellent customer relations aptitude and relationship-building skills. Proficient in using independent decision-making skills and sound judgment to positively impact company success. Dedicated to applying training, monitoring and morale-building abilities to enhance employee engagement and boost performance.
Education
Bachelor of Arts - Biological Sciences
University of Mississippi
University 01.2006 - 12.2007
Timeline
Manager, Biomanufacturing
Charles River Labs (CDMO)
05.2023 - Current
Supervisor, Biomanufacturing
Charles River Labs (CDMO)
09.2019 - 05.2023
Lab Technician/ Specimen Processor
Idexx Laboratories
04.2019 - 09.2019
Sterile IV compounding technician Lead
SCA Pharmeceuticals
07.2015 - 12.2018
Quality Associate Supervisor – Clean Room
Pharmedium Healthcare Corporation
06.2014 - 04.2015
Lead Compounding Pharmacy Technician (Clean Room)
Pharmedium Healthcare Corporation
03.2012 - 06.2014
Compounding Pharmacy Technician (Clean Room)
Pharmedium Healthcare Corporation
01.2011 - 03.2012
Production Pharmacy Technician
Pharmedium Healthcare Corporation
09.2009 - 01.2011
Bachelor of Arts - Biological Sciences
University of Mississippi
01.2006 - 12.2007
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