JANICE STANCILL

Develop and maintain an understanding of the requirements of the FDA, AATD, ISO 13485, MDSAP, and other regulatory jurisdictions, as applicable, to help the company lead the Medical Device and Biologic's Industries it quality practice.

Adhere to Xtant SOPs and safety protocols, FDA regulations for Human Cells, Tissues, and Cellular and Tissue-Based products (HCT/P's and Devices; operation in compliance with FDA, AATB, ISO, and OSHA standards.

Develop and maintain an understanding of Xtant products and general biological and chemical systems utilized within the Department. Know how the activities performed in the Department are controlled by and interact with Quality System and how they affect production of medical devices and tissues as applicable.

Support Xtant's mission to honor the gift of donation, by allowing our patients to live as full and complete a life as possible.

Good Manufacturing Practice (GMP), Standard operating procedures (SOPs), and Personal Protective Equipment (PPE) standards.

Manufacture finished products for Biologic's.

Places requisitions for manufacturing materials Performed preventative maintenance on various pieces of equipment.

Helped with Validations

Worked in SAP

Maintained proper documentations of all work performed.

Improved product quality by implementing rigorous quality control checks at various production stages.

Experience in Lyophilization, Granulating, Depyrogenation, Sterilization, Filling, Packaging, Labeling, and inspection of products.

Ensure all components were processed and ready for each batch.

Utilized Labwashers, Dry Heat Ovens, Autoclaves, and Drying oven for Manufacturing parts.

Maintained accurate records of production data, enabling informed decision-making based on real-time insights.

Monitored inventory levels, ensuring adequate stock of raw materials and consumables for uninterrupted production operations.

Managed multiple simultaneous projects effectively while ensuring deadlines were met consistently without compromising quality or productivity levels.

Reduced machine downtime by implementing preventive maintenance procedures and regular inspections.

Aided in setting up and breaking down production equipment and stages to help prepare production area for filming and properly store equipment after use.

Operated various equipment for production such as Freeze Dryers, Tray Sealer, Bar sealer, and Shrinkwrap machine.

Submitted Kaizen card ideas

Streamlined inventory management processes, ensuring ready availability of necessary materials without overstocking.

Monitored and adjusted production equipment for optimal performance, ensuring consistent product quality.

Assist QA on documentation and with WI's.

Milling of freeze dry products, and Nanoss Foam

Collection of water samples, and products to be sent out for certain testing to be completed.

Inspected products and machines to maintain quality and efficiency.

Tested products or subassemblies for functionality or quality and troubleshot problems with equipment, devices, or products.

Enhanced data gathering, extraction and analysis for diverse workflows and procedures.

Troubleshot equipment malfunctions quickly to minimize disruptions in production schedules.

Increased workplace safety, conducting thorough hazard assessments and implementing corrective actions.

Reviewed Batch Records

• Trained new team members on company protocols, safety procedures, and equipment operations, ensuring a skilled workforce.
• Promoted a positive work environment through effective communication, teamwork, and mutual respect among colleagues.
• Reduced equipment downtime by performing timely maintenance and troubleshooting technical issues.
• Prepared production documents such as standard operating procedures, manufacturing batch records and inventory reports.
• Maintained accurate documentation of all production activities, ensuring traceability and accountability throughout the manufacturing process.
• Performed root cause analysis on defects or failures found during quality inspections, resulting in corrective actions that improved overall product reliability.
• Implemented cost-saving measures by identifying areas for improvement within the manufacturing process, reducing operational expenses without compromising quality standards.
• Participated in regular safety meetings and training sessions to ensure a culture of safety-consciousness among team members.
• Prepared and assembled materials, and tested products or subassemblies for functionality and quality.
• Supported continuous improvement initiatives through active participation in kaizen events, leading to process enhancements.
• Collaborated with cross-functional teams to ensure smooth workflow and timely completion of projects.
• Transferred hazardous or non-hazardous waste materials to collection areas for disposal, recycling or reuse.
• Contributed to inventory control by accurately tracking raw materials usage and finished goods stock levels.
• Increased overall productivity with effective time management strategies and efficient work procedures.
• Achieved consistent on-time delivery of customer orders through proactive planning and diligent monitoring of production progress against deadlines.
• Optimized manufacturing processes using Lean principles, resulting in reduced waste and increased output.
• Utilized strong analytical skills to identify bottlenecks in the production line, enabling targeted improvements for greater efficiency.
• Enhanced product quality through rigorous testing and adherence to industry standards.
• Lubricated and cleaned parts to perform routine maintenance on production equipment.
• Performed setup of production equipment to establish optimal performance.
• Trained and supervised production personnel to properly use production equipment and apply best practices.
• Inspected equipment and systems to identify issues, immediately reporting problems to repair technicians.
• Promptly documented and reported all defective equipment and hazardous conditions.
• Aided in setting up and breaking down production equipment and stages to help prepare production area for filming and properly store equipment after use.
• Made sure that products were produced on time and are of good quality.
• Read worker logs, product processing sheets or specification sheets to verify records adhered to quality assurance specifications.
• Performed general equipment maintenance and repair to minimize downtime.
• Examined incoming materials and compared to documentation for accuracy and quality.
• Tested products or subassemblies for functionality or quality and troubleshot problems with equipment, devices, or products.
• Inspected products and machines to maintain quality and efficiency.
• Prepared reports and technical documentation of day-to-day production processes.
• Built product subassemblies or final assemblies and monitored and adjusted production processes or equipment for quality and productivity.
• Enhanced data gathering, extraction and analysis for diverse workflows and procedures.
• Improved production efficiency by streamlining assembly processes and implementing innovative solutions.
• Safeguarded workplace safety by adhering to OSHA guidelines and reporting potential hazards promptly.
• Evaluated machine performance data regularly to identify trends or anomalies suggestive of imminent equipment failure so preventive action could be taken before an issue arose.
• Effectively communicated with team members across various departments to resolve any issues impacting production schedules or performance metrics promptly.
• Maintained accurate production records to track progress, identify areas for improvement and meet regulatory requirements.
• Tested selected products at specified stages in production process for performance characteristics or adherence to specifications.
• Scheduled preventive and predictive maintenance actions based on failure analysis.

• Wore necessary personal protective equipment to minimize risks from hazardous materials, biohazards, and other harmful substances.
• Ensured timely completion of assigned tasks by effectively prioritizing workload based on urgency and importance.
• Emptied trash cans and recycling bins to promote clean, sanitary environment, and reduce odors and debris.
• Used chemicals by following safety protocols and procedures to avoid burns and injuries.
• Utilized chemicals and cleaning equipment to meet facility's predetermined sanitation and cleanliness quality standards.
• Reduced cross-contamination risks with thorough cleaning practices and proper disposal of hazardous materials.
• Enhanced cleanliness standards by consistently adhering to established protocols and using appropriate cleaning solutions.
• Showcased exceptional work ethic and reliability, contributing to team success and maintaining high levels of cleanliness throughout the facility.
• Disposed of trash and recyclables each day to avoid waste buildup.
• Slid beds, sofas, and other furniture aside to wipe down baseboards and remove dust and dirt from hard-to-reach areas.
• Verified cleanliness and organization of storage areas and carts.
• Cleaned elevators, glass, and planters in public areas.
• Documented and reported necessary facility and building repairs observed.
• Streamlined inventory management processes by accurately tracking usage patterns of cleaning supplies and submitting timely orders for replenishment.
• Kept public pathways clear of safety hazards and spills with regular checks and attention.
• Maintained cleanliness of restrooms by washing down and properly sanitizing walls, floors and toilets.
• Performed daily facility checklists for cleaning floors, wiping down glass entryways and collecting trash.
• Responded immediately to calls from personnel to clean up spills and wet floors.
• Maintained optimal supply levels to meet daily and special cleaning needs.
• Identified repair needs and major maintenance concerns, and escalated issues to management.