Jaye Greene Email & Phone Number

Duluth, Mn, Us

Philadelphia, Pennsylvania, United States

In this role, I was responsible for the QMS documentation to support the Joint Audit Program, such as the Quality Manual, SOP's, and WI's, as well as maintaining periodic review of the Rx-360 proprietary audit checklists and supporting the CAPA team. I launched and managed internal improvement efforts related to tightening the quality control inspections of auditor qualification evidence and the final licensable report package documents to ensure accuracy and consistency. I provided support for tracking training activities, handling customer complaints, managing the CRM database and its related access-controlled customer portal, and helped to manage the confidential working group, the Audit Operations Group (AOG).

Focused on Process Optimization, in this role I worked to build and improve the internal systems at Rx-360. I reviewed processes to find weak points or gaps, and developed solutions to tighten controls and eliminate inefficiencies. I was the resource for the internal team if anyone experienced database glitches or discovered documentation errors - quickly responding with the resolution to support the team. I prepared process plans for management such as proposing methods to better monitor vendors and track internal training. I worked to uncover compliance gaps to prepare for periodic membership audits.

Duluth, Mn, United States

In March 2021, my role grew to managing the entire Joint Audit Program, covering Licensing, Audit Scheduling, and CAPA management, as well as the Quality side of the program. With 5 direct-reports, I managed my team with compassion and collaboration, helping them see the interconnectedness of their positions. I held recurring team meetings and conducted personnel evaluations. I also managed the QMS and worked to resolve the previous internal audit observations, in preparation for the next membership audit Rx-360 would host.

Philadelphia, Pennsylvania, United States

As Head of Audit Operations, I was initially tasked with formulating a control system for Rx-360's License Program. Finished audit report packages would be made available to the pharmaceutical industry for licensing and I immediately recognized that process needed to be repeatable and tracked. I developed the improved system for separating the legal documents required of customers from the business documents needed, easing the paperwork burden for all. I created the License Transaction Record (LTR) so there could be a unique record for each license transaction (essentially an order confirmation). This effort transformed Rx-360's License Program into a controlled process and eased month-end number crunching.In this position, I was also liaison to the Head of Quality, as we worked together to plan and schedule the joint audits. We collaborated on documenting the audits, managing the audit vendors, and reporting the financial details to management.

Fort Collins, Colorado Area

I am responsible for maintaining the site’s certifications to ISO 9001:2015, and ISO 13485:2016, as well as compliance to FDA 21 CFR 820 regulations. During these 5 years in quality, I have hosted 80+ audits, two FDA inspections, and implemented/closed the corrective action plans for the resulting observations. I am responsible for ensuring compliance to QMS requirements related to our ISO 14644 certified Class 8 cleanroom, controlled documents, tracking training, validation, and the approved supplier list. I am a team member of the BPOG/Rx-360 joint audit pilot program for SUS. I also help keep the material regulatory compliance documentation current and ensure customer-facing COC’s are up to date.

Fort Collins, Colorado Area

In 2004, I was invited to shift from my customer service role at the company, to help restructure the sales department. Over my 10 years in sales, I developed a strong product knowledge of our 8000+ SKU's of injection molded medical connectors and provided product information and technical guidance to the customers in my assigned territory. I was responsible for managing 200+ customers, processing special orders through the ERP system, and tracking prospective leads through the CRM. Hosted the company booth at the annual MD&M tradeshow 7 times. Consistently achieved sales goals, and consistently maintained a customer focus while keeping a positive and professional attitude.

Fort Collins, Colorado Area

During my time in Customer Service, I answered customer calls, processed customer orders, and communicated with customers through email regarding status updates. I transferred calls to the sales team and the technical department. I worked with production teams to manage delayed shipments, and to correct inaccuracies in the ERP system. This was a great job to introduce me to the products, and to the software systems in place. It became an important step in developing my customer relations skills, preparing me to the next phases of my career.