Joseph Frain
Boyertown
Summary
Experienced in product life management, auditing, and change control, with a proven ability to resolve matters effectively.
Overview
20
20
years of professional experience
Work History
Senior UDI Documentation
Teleflex
06.2019 - Current
- Medical Device Reporting
- FDA compliance
- Change management for UDI and SAP
- Global product data extensions
- DSD data quality assurance
- PLM for Vascular medical products
Substitute Teacher
Kelly Educational Staffing
01.2019 - 06.2020
- Reading Area School District
- Hamburg Area School District
- Wyomissing Area School District
Project Manager
Davies Hardscaping, LLC
06.2017 - 01.2019
- Project preparation
- Assigning personnel
- Overseeing loss prevention
- Laborer
- Hardscaping, landscaping, and architectural design for commercial and residential properties.
(Contract) Field Inventory Auditor
Olympus Corporation of the Americas
11.2016 - 06.2017
- Inventory and asset auditor for Life Science and Industrial sales representatives in compliance with J-SOX regulations.
- Led all auditors and consultants in the first quarter of 2017 with 86 completed Life Science audits (99% accuracy rating)
- Completed adjustments to synchronize assets in SAP and SFDC
- Performed validation procedures for all capital and disposable items
- Assisted asset management and asset retrieval teams on the back end of audits
- Coordinated 3rd party audits and pick-up schedules for unidentified or invalidated inventory
- Managed storage utilities for all field inventory sales representatives
- Conducted monthly storage analysis using pivot tables
- Coded monthly storage invoices for the accounting team
(Contract) Internal Auditor
Synchronoss Technologies
03.2015 - 11.2016
- Internal IT auditing and information access management in compliance with ISO strategy
- Project management
- Information access
- Access recertification
- Assisted Change Control administration
- Monitored internal controls, policies and SOPs.
- Generated monthly compliance reports
- Facilitated and moderated department audits
- Assigned personnel to data requests
Data Analyst II
Health Market Science (LexisNexis)
08.2013 - 01.2015
- Led all auditors in Standard Licensing Agreement audits for Medicare and Medicaid services
- Awarded a spot bonus for outstanding achievement in the fourth quarter of 2014
- Contributed to process improvements by innovating pre-existing auditing procedures
- Trained team members and new employees in auditing processes, procedures and regulations
- Participated in a team effort to train the entire organization on a new product
- Provided technical writing and feedback for special projects
- Provided immediate assistance to clients
- Compliance and solutions company working in partnership with pharmaceutical companies and specific government contracts, auditing, maintaining and distributing data for over 8.1 million health practitioners and more than 450,000 health organizations.
Insurance Claims Administrator
United States Liability Insurance
08.2012 - 05.2013
- Providing immediate and personal assistance to insured, claimants and attorneys
- Claim reporting
- Paying Invoices
- Replying to claim status requests
- Creating contacts for victims.
- Data entry
Manager
The Bears’ Den Restaurant
01.2006 - 04.2012
- Family owned restaurant, working a server, cook and a kitchen manager.
Education
Bachelor of Communications -
Penn State University
Skills
- FDA compliance
- UDI documentation
- Change management
- Data quality assurance
- PLMD for medical products
- Project management
- Inventory auditing
- Regulatory reporting
- Effective communication
- Problem solving
- Attention to detail
- Computer skills
- Project planning
- Recordkeeping
Timeline
Senior UDI Documentation
Teleflex
06.2019 - Current
Substitute Teacher
Kelly Educational Staffing
01.2019 - 06.2020
Project Manager
Davies Hardscaping, LLC
06.2017 - 01.2019
(Contract) Field Inventory Auditor
Olympus Corporation of the Americas
11.2016 - 06.2017
(Contract) Internal Auditor
Synchronoss Technologies
03.2015 - 11.2016
Data Analyst II
Health Market Science (LexisNexis)
08.2013 - 01.2015
Insurance Claims Administrator
United States Liability Insurance
08.2012 - 05.2013
Manager
The Bears’ Den Restaurant
01.2006 - 04.2012
Bachelor of Communications -
Penn State University