JEFFERY SHANE CARLTON
High Springs,FL
Summary
20+ years in a manufacturing environment, with 18 years dedicated to being a medical device professional within the FDA regulated industry.
Overview
28
28
years of professional experience
Work History
Manufacturing Specialist (Downstream)
Resilience
10.2022 - 01.2024
- Performed downstream production related actives in a cGMP manufacturing core according to SOPs such as chromatography purification (AKTA, AKTA XL), centrifugation / ultracentrifugation, diafilteration / ultradiafilteration, aseptic technique and viral clearance.
- Batch record review to ensure GDP with some deviation exposure.
- Gathered / requested materials and prepared tubing assemblies for production projects.
- Issurance and reconciliation of materials to ensure accurate real-time inventories.
- QAD, Veeva and MasterControl experience.
Quality Control Inspector
TeledyneFlir
09.2021 - 07.2022
- Communicated with production team members about quality issues.
- Performed visual inspections and non-destructive tests where appropriate.
- Reported repeated issues to supervisors and other departments, collaborating to identify issue roots and rectify problems.
- Evaluated components and final products against quality standards and manufacturing specifications.
- Conducted tests and diagnostic procedures using tools such as analyzers, multimeters and power supplies.
- Monitored production processes to gain understanding of problematic steps and rectify issues.
Insurance Agent
Farmers Insurance Agency
04.2021 - 07.2022
- Maintained high standards of customer service by building relationships with clients.
- Responded to customer calls swiftly to resolve issues and answer questions.
- Determined client needs and financial situations by listening and scheduling fact-finding appointments.
- Approached potential clients by using direct marketing mailings and phone contacts.
- Sold auto, home, life and other various insurance products to individuals and affinity groups within assigned territory using consultative selling techniques.
QA Technician II
Exactech
02.2017 - 04.2021
- Inspection and acceptance of in-process and finished product
- Help create, maintain, and install CamStar (Inventory control program)
- Perform and document inspection requirements following approved SOPs for incoming, in process, OEM and finished products
- Document and notify QC Manager of non-conformances
- Perform and document inspection requirements following approved SOPs for tissue and tissue related products
- Document and notify QC Manager and/or Tissue Bank Director of non-conformances
- Status products according to inspection procedures to ensure that product identification and traceability is accurate and prevents product mix-up
- Process product returns through the QA quarantine system and disposition to the appropriate electronic and physical locations
- Ensure product complaints are documented according to procedure with clear status for further evaluation as required
- Perform sterile lot receipt of implant products and document any deviations through the non-conforming materials process
- Perform sterile lot release of implant products and document any deviations through the non-conforming materials process.
QA Technician II
Invivo (Philips)
06.2013 - 01.2017
- Inspection and acceptance of in-process and finished product to, -610 & IPC-620 requirements
- Approval of all production products and rework
- Assisting/training of co-workers/employees (when needed)
- Assist in continual improvements to production/QA processes using CAPA system
- Review device labeling for accuracy and conformance with label requirements
- Review and approve device history records in accordance with established procedures.
Assembly Technician
Invivo (Philips)
01.2013 - 06.2013
- Manufacturing of electrical/RF products (using soldering iron, solder vac.,multimeter, etc.)
- Inspected equipment for proper performance and correct specifications
- Installed, maintained and recommended appropriate solutions for electronic products
- Train co-workers/new hires on manufacturing of product lines
- Installed, repaired and troubleshot product defects
- Interpreted schematic blueprints/drawings, wiring diagrams and performance specifications
- Conducted diagnostic and operational tests.
QA Complaint Investigator
Invivo (Philips)
01.2010 - 01.2013
- Evaluate, create, manage, resolve and respond to customer complaint cases/claims for damaged or defective products using TrackWise
- Created and maintained a feedback system of customer complaint information for current and future product improvements
- Created complaint trending reports in support of quality management review
- Help identify and solve technical issues with a variety of different parts of the business (QA, R&D, Production, etc.)
- Training of co-workers/staff in customer complaint procedures and adoption of new QCtA program procedures
- Created or revised procedures in developing complaint processes and roll out new procedures adopted by the QctA program using the Invivo's document and change control processes
- Verified adequacy of product specifications and risk controls based upon complaints and adverse events
- Reviewed device history records to confirm conformance with device master record
- Participated in CAPA processes and conducted root cause analysis
- Maintained complaint records in accordance with 21 CFR 820.198 and CMDR Section 57
- Assessed complaints against FDA and GHTF adverse event reportability criteria.
QA Inspection Specialist
Invivo (Philips)
01.2007 - 01.2010
- Inspection and acceptance of in-process and finished product to, -610 & IPC-620 requirements
- Approval of all rework
- Assisting/training of rework (when needed)
- Assist in continual improvements to production processes using CAPA system
- Reviewed device labeling for accuracy and conformance with label requirements
- Reviewed and approved device history records in accordance with established procedures.
Lead Assembly Technician
Invivo (Philips)
01.2002 - 01.2007
- Manufacturing of electrical/RF products (using soldering iron, solder vac.,multimeter, etc.)
- Inspected equipment for proper performance and correct specifications
- Installed, maintained and recommended appropriate solutions for electronic products
- Train co-workers/new hires on manufacturing of product lines
- Installed, repaired and troubleshot product defects
- Interpreted schematic blueprints/drawings, wiring diagrams and performance specifications
- Conducted diagnostic and operational tests.
Assembly line lead
Sabine Inc
01.1996 - 01.2002
- Manufacturing of electronic equipment (using soldering irons, solder vac., multimeter, etc.)
- Help maintain line production for parts of M.I
- Department
- Interpreted schematic blueprints/drawings, wiring diagrams, and performance specifications
- Installed, repaired and troubleshot product defects
- Train co-workers/new hires on manufacturing of product lines.
Education
No Degree - Commercial And Industrial Wiring
Santa Fe College
Gainesville, FLHigh School Diploma -
Hawthorne Jr. / Sr. High
Hawthorne, FL1998
Skills
- Maintaining Quality Assurance Standards
- Test Data Documentation
- Equipment Function Testing
- Corrective Action Recommendations
- Inspection and Testing Reports
- Specifications Conformance
Timeline
Manufacturing Specialist (Downstream)
Resilience
10.2022 - 01.2024
Quality Control Inspector
TeledyneFlir
09.2021 - 07.2022
Insurance Agent
Farmers Insurance Agency
04.2021 - 07.2022
QA Technician II
Exactech
02.2017 - 04.2021
QA Technician II
Invivo (Philips)
06.2013 - 01.2017
Assembly Technician
Invivo (Philips)
01.2013 - 06.2013
QA Complaint Investigator
Invivo (Philips)
01.2010 - 01.2013
QA Inspection Specialist
Invivo (Philips)
01.2007 - 01.2010
Lead Assembly Technician
Invivo (Philips)
01.2002 - 01.2007
Assembly line lead
Sabine Inc
01.1996 - 01.2002
No Degree - Commercial And Industrial Wiring
Santa Fe College
High School Diploma -
Hawthorne Jr. / Sr. High
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