Kara Beal

• Hands-on experience in cell culture in biosafety cabinet and single-use manufacturing
• Experience creating and maintaining Standard Operating Procedures (SOPs), batch records, Jobaids and following aseptic technique in accordance with current Good Manufacturing Practice (cGMP)
• Proven ability to work independently in team environment under pressure
• Single-use upstream cell expansion and transfection of embryonic suspension cells
• Assisted in Start Up activities for Gene Therapy, includes training and assisting automation, technical operators and engineer operators during water runs in Upstream operation
• Key contributor for creation, maintenance with continuous improvement for all Standard Operating Procedures (SOPs) and batch record in Upstream Operations
• Maintained GMP practices and documentation, such as SOP’s, Test Methods and batch records on how to prepare and maintain material during a manufacturing procedure
• Applied existing techniques and procedures, with recommendations, and implement modifications for improved efficiency
• Accountable for required training, documentation, and technical completion of work in a regulated cGMP environment
• Provide process execution and equipment operational support for cGMP commercial manufacturing
• Worked with Bioprocessing Technicians to ensure safe, compliant, and efficient execution of production tasks
• Conduct analytical activities such as sample dilutions, pH, and conductivity readings
• Collaborate with Management, Leads/Coordinators, and Process Engineers to resolve issues and fulfill manufacturing requirements
• Ensure compliance with Company policies, SOPs, Pfizer Values, and global regulatory guidelines (including cGMP/cGLP/cGCP)
• Advise management of non-conformance issues and opportunities for continuous improvement
• Performing all manufactured pharmaceutical testing and duties in compliance with FDA, cGMP guidelines
• Participated in COM, CTM, ENG and PPQ runs from Vial Thaw to Harvest Transfer
• Knowledge in Operating Laboratory Information Management System (LIMS)
• Experience with operating and maintaining SAP system for all material pertaining to manufacturing procedures
• Led multiple Tier meetings through Digital Operations Center
• IMEX Visual Management for Digital Operations Center (DOC)
• Exercise and build basic team effectiveness skills, such as commitment, feedback and consensus management, within the work group

Safety Committee Area Lead for Gene Therapy

• Serve as the designated “sweeper” for the area during evacuations or shelter-in-place activities
• Participate in annual training sessions for safety committee members
• Develop and update relevant safety training specific to the area
• Assign and train a back-up Safety Committee Member for the area
• Organize and lead monthly meetings with area safety champions to discuss safety metrics, corrective and preventive actions (CAPAs), and initiatives to prevent or address issues
• Record attendance at monthly safety champion meetings
• Attend the Site’s monthly safety committee meetings (led by Sanford EHS) and provide updates on the designated area’s challenges and successes to EHS
• Review, escalate, or approve monthly area safety inspections in the EHS Incident Management System, and assign actions to Safety Champions if inspections are overdue
• Analyze monthly safety trends for the area in the EHS Incident Management System and communicate the importance of reporting near-misses, safety/compliance concerns, and recognizing safe choices
• Participate in EHS incident investigations as requested
• Share all EHS communications during DOC meetings and other area/departmental forums
• Delegate duties within the area to ensure compliance before inspections or audits
• Provide assistance, suggestions, concerns, and questions to the EHS liaison
• Coach colleagues to report unsafe conditions, near misses, and incidents in the EHS Incident Management System.
• Maintained a safe work environment by strictly adhering to established safety protocols and guidelines.
• Trained new technicians on standard operating procedures, ensuring consistency across the team.
• Maintained compliance with regulatory standards and safety requirements.

• Provide laboratory support that includes cleaning and storing glassware, unpacking chemicals and entering them into electronic system, scanning consumed chemicals out of electronic system and disposing of containers, restocking consumables, laboratory cleaning, and other general tasks
• Provide sample support to include receiving and logging samples, raw materials, and components into electronic inventory system, checking samples out to lab team
• Preparing documents and processing test procedures from different internal projects
• Following SOP’s and Test Methods on how to prepare and maintain material
• Provide support to hazardous waste team by maintaining and disposing chemical waste properly and efficiently
• Independently performs inhalation pharmaceutical testing to support drug product formulation, and manufacturing
• Maintains GMP and non-GMP documentation in electronic notebook systems
• Working in Research and Development facility test exhibit batches to ensure samples meet FDA regulations
• Testing Proficient in testing Aerodynamic Particle Size Distribution by Next Generation Impactor, evaluating Single Actuation Content, conducted Spray Pattern and Plume Geometry testing
• Knowledgeable on use of Scicord and Proveris systems
• Reviewed protocols and technical reviewed reports
• Performing pharmaceutical testing and duties in compliance with FDA, USP, EP, cGMP guidelines.
• Recorded and analyzed data to produce reports of results.
• Assisted scientists by collecting and organizing laboratory data.
• Prepared reagents and solutions following standard laboratory formulas and procedures.

• Provide laboratory support that includes cleaning and storing glassware, unpacking chemicals and entering them into electronic system, scanning consumed chemicals out of electronic system and disposing of containers, restocking consumables, laboratory cleaning, and other general tasks
• Provide sample support to include receiving and logging samples, raw materials, and components into electronic inventory system, checking samples out to lab team, performing and documenting routine temperature and humidity monitoring of chambers and rooms, supporting stability sets and pulls.

• Helps to fulfill customers’ needs by providing friendly, courteous and efficient services
• Aids assistance and information on product features
• Ability to acknowledge and resolve problems that customers might have
• Responsible for cash register operations which includes correctly handle all register transactions, Handling Returns/Complaints graciously and effectively
• Helps health care providers and patients by greeting them in person and by phone; answering questions and requests; referring inquiries to the pharmacist
• Maintains pharmacy inventory by checking pharmaceutical stock to determine inventory level; anticipating needed medications and supplies; placing and expediting orders; verifying receipt; removing outdated drugs
• Maintains a safe and clean pharmacy by complying with procedures, rules and regulations
• Protects patients and employees by adhering to infection-control policies and protocols
• Organizes medications for pharmacist and technicians to dispense by regarding medication orders and prescriptions; preparing labels; calculating quantities
• Maintains records by recording and filing physicians’ orders and prescriptions
• Generates revenues by calculating, recording and issuing charges
• Ensures medication availability by delivering medications to patients
• Contributes to team effort by accomplishing related results as needed.

• Helps to fulfill customers’ needs by providing friendly, courteous and efficient services
• Aids assistance and information on product features
• Ability to acknowledge and resolve problems that customers might have
• Responsible for cash register operations which includes correctly handle all register transactions, Handling Returns/Complaints graciously and effectively
• Ability to acknowledge and resolve customer problems
• Responsible for customer services, merchandising, store inventory, assisted and help maintain displays throughout the store
• Provides advices to customer regarding to products and services
• Answered customers’ queries and concerns
• Ensures the store is neat, clean and organized throughout each business day
• Knowledge of product location
• Aware of current promotional items and correct pricing
• Participates in store opening and closing tasks.

• Seed Processing Assistant: Threshing, counting, weighing and packaging regulated and non-regulated seed from Greenhouses
• Entering data into the Laboratory Inventory Management Software, processing seed and subsampling for QC and seed shipment packets
• Operating seed counters, heat sealers and balances
• Keeping accurate computer-based records of seed inventory
• Performing a variety of routine seed handling and accurate computer-based records
• Documenting detailing detailed temperature and humidity recordings and QC checks
• Following SOP’s and WI instructions on how to maintain seed inventory and storage
• Greenhouse Technician: Helped preparing pots planting and transplanting, harvesting and watering
• Helped maintain plant inventory by updated data such as location scanning, disposal, harvesting
• Archive Assistant: Preparing documents and labeling seed received from different internal projects
• Following SOP’s and WI instruction on how to prepare and maintain seed archive inventory and storage
• Operating seed counters, heat sealers and balances
• Performing a variety of routine seed handling tasks and maintaining accurate computer-based records
• Keeping accurate seed archiving processes and additional updates on lab equipment and seed storage areas
• Performing germination and moisture tests as well as accurate documentation for each process
• Detailed documentation on temperature and humidity recordings
• Created user manual for Archiving based of the Operating Laboratory Information Management System processes
• Assisted in developing work instructions and SOP’s
• Backup Gatekeeper: Responsible for shipping and receiving biological material worldwide
• Accurate computer-based records
• Knowledge of handling a variety of highly regulated materials
• Scanning and confirming that all requirements are met for shipping biological material.

• Caring for large and small animals by assisting with vaccines, deworming
• Operating farm equipment
• Cleaning stalls, groomed horse, work with and trained colts & fillies
• Greenery work.