Alexis Thomas
Smith & Nephew Orthopedics
New Braunfels,TX
20
years of professional experience
Detail-oriented Document Control Specialist with a proven track record at Smith & Nephew Orthopedics. Expert in CGMP practices and document management, ensuring compliance and quality assurance. Strong communicator and problem solver, adept at coordinating schedules and maintaining controlled inventory to support seamless manufacturing operations.
Work History
Document Control Specialist
6 Years 7 Months- Assign product lot numbers and issuance and inspection of batch records associated with each manufacturing process
- Generate and visual inspect product labeling for all products in current production
- Generate printing and inspection paperwork according to established procedures and good documentation practices
- Coordinate printing schedule based on production plan to ensure manufacturing operations are not halted through lack of batch records or production labels
- Scan, file, and archive quality records
- Maintain Controlled inventory
- Pack and verify quality records to be sent off-site storage
Inspection and Packaging Tech
3 Years 5 Months- Ensure proper identification and label for all final product
- Ensure cold storage areas are maintained in a neat and orderly manner
- Certified Inspector for visual inspection
- Strong adherence to CGMP regulations, CBI policies, CBI SOP, and batch record directions
- Perform cleaning and preparation of all equipment necessary for the daily inspection area and packaging room
- Monitor of chart records daily
- Submission of sampling for testing in accordance to written procedures
- Ensure Quality of manufactured goods
- Review of packaging Record in-process at completion of process prior to QA review.
Machine Operator
5 Years 11 Months- Set up and calibrated machinery to maintain consistent production output and product quality.
- Monitored equipment performance and adjusted controls to prevent downtime and defects.
- Inspected finished products for accuracy, cleanliness, and compliance with quality standards.
- Performed routine maintenance and cleaning to keep machines operating safely and efficiently.
Education
High School Diploma
Skills
Auditing Documents
Document Management
File Conversion
Document Review
CGMP Practices
Microsoft Office
Visual Inspection
Quality Assurance
Communication
Packaging
Problem Solving
Machinery Maitenance
Timeline
Document Control Specialist
Smith & Nephew Orthopedics
12.2019 - 07.2026Read More
Inspection and Packaging Tech
Emergent BioSolutions
05.2016 - 10.2019Read More
Machine Operator
Medifast Weight Loss Clinic
07.2006 - 06.2012Read More
Woodlawn High School
High School Diploma
Read More