Elena Bailey Email & Phone Number

Analyst III, Complaint Vigilance, August 2022 – present• Determines need for complaint/adverse event investigation for three manufacturing sites and twenty-seven external manufacturing sites• Triages ~ 445 complaints per month• Actively develops and manages relationships with Call Centers, Medical Safety, Marketing, internal affiliates, and external sites• Ensures quality culture through the alignment of an end-to-end complaint vigilance process• Provided continued support for previous role at JJCI Lancaster through April 2023

Lancaster, Pennsylvania, United States

Accomplishments - See Complaint Specialist II Complaint Program Lead• Led all aspects of consumer complaint process for manufacturing site, such as complaint investigation, reporting of complaint metrics, and the processing of returned field samples• Assessed production records, investigations, change controls, CAPAs, analytical/microbiological results, complaint trends, and regulations to identify potential impact to quality and compliance• Managed the storage of returned field samples and the site field sample destruction processSupplier Quality Management• Partnered with site Quality, Operations, Procurement, and Suppliers/Service Providers ensuring supplier quality and preventing supply chain disruptions• Coordinated Import for Export (IFE)/Temporary Importation under Bond (TIB). Assembled/submitted documentation to Customs Border Control. Managed IFE/TIB material destruction process• Delivered guidance and instruction regarding IFE/TIB to sites new to the process regarding the provision of documentation to the government, including the required content, format, and structure• Reviewed supplier-related change controls and investigations to assess impact during Annual Product Review (APR)Site Compliance• Performed site monthly metrics• Performed, reviewed, and trained others to perform APR contributions• Inspection readiness, internal auditing, and site support during regulatory inspections. Member of the inspection management team and Audit Tracking Management System (ATMS) Administrato• Wrote responses to inspection observations and investigations• Maintained site quality agreements. Reviewed and provided feedback for proposed updatesDocument Control• Document Initiator for the Compliance Team• Created, revised, and obsoleted documents• Revised site and network-level procedures

Lancaster, Pennsylvania Area

Accomplishments:• Acting complaint supervisor from 2014 – 2015. Effectively managed Lancaster Complaint Vigilance team, including onboarding and training a new hire while simultaneously processing and reviewing complaints • Site Complaint SME for FDA inspections and Complaints Community of Practice• Self-taught the methodologies for adult learning and developed a five-part course covering quality principles and cGMPs. Course was source material for Annual GMP Training for 2018, 2019, and 2020.• Developed tools and best practices to increase team efficiency, cycle time adherence, and right the first time (RFT) metrics. Team monthly cycle time reduced 85%. Team RFT increased 15% • Oversaw construction of consumer field sample storage area resulting in successful verification during Consent Decree Remediation• Employee Resource Group Lead

Accomplishments:• Learned complaints process in less than two weeks, while performing regular job duties enabling a seamless transition from previous complaint coordinator• Developed/implemented practices to reduce cycle time and facilitate efficient investigation of complaints, enabling the processing of 264 complaints in two weeks• Authored complaints process manual and trained team members on complaints processFunctions:• Inspected, tested, and dispositioned incoming, in-process, and finished materials • Performed laboratory testing for microbiological performance/cultural response• Reviewed laboratory documentation for relevancy, accuracy, and uniformity • Managed complaints and partnered with Technical Support to ensure that complaints were investigated, processed, and closed in a compliant and timely manner• Composed industrial response letters and communicated formal complaint investigation results to industrial customers

Accomplishments: • Defined new role from a list of objectives which streamlined department workflow• Oversaw organization of the new retention sample storage area, ensuring it was brought into compliance.• Created inventory and records management system for inventory and retention samples.• Authored the stock media SOP.Functions:• Managed procurement and inventory of raw materials reagents, stock media, retention samples, and records. Created inventory management system.• Performed laboratory testing of stability samples for microbiological performance/cultural response• Supported R&D and complaint investigations through the procurement of supplies and provision of retention samples.

Master’S Degree, Regulatory Affairs & Quality Assurance, 3.95

The Temple RA/QA Program is the most established and comprehensive graduate curriculum of its kind. It fulfills regulatory requirements.

Drug Development Certificate, Regulatory Affairs & Quality Assurance, 4.0

Study Abroad

The Randolph-Macon Woman's College Study Abroad Program at the University of Reading, in Reading, Berkshire, United Kingdom was.

Bachelor’S Degree, Biology, General

Education record

Education record