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Validation Specialist Resume Samples
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Candidate Info
20
years in workforce
5
months at this job
BA
Spanish / International Business
Validation Specialist
- Drafted protocols and reports for semi-automated and fully automated auto injector devices.
- Reviewed completed protocols for documentation and execution errors.
- Assisted project lead by attending process meeting and providing detailed meeting minutes to the team on a daily basis.
Candidate Info
12
years in workforce
4
years at this job
BS
Mechanical Engineering
Nuclear Engineering
Validation Specialist III
- Managed multiple contractors during cleaning validation execution of a new bulk mammalian cell culture and fill/finish facility. Coordinated and scheduled cleaning validation activities with Manufacturing, QC, QA, and Process Engineering. Authored regulatory submission documents related to cleaning validation.
- Executed shipping validation for shipments of small volume samples, bulk product, and filled/finished product from the manufacturing facility to domestic and international destinations.
- Authored and executed qualification protocols for purification equipment (UF/DF, Chromatography, Ultracentrifuge) utilized in a new bulk mammalian cell culture manufacturing facility.
- Authored and executed qualification protocols to qualify the Water for Injection and Purified Water distribution system and points of use for a bulk manufacturing and fill finish facility. Coordinated and managed the execution of water sampling during performance qualification activities.
Candidate Info
19
years in workforce
5
years at this job
BA
Business Administration
Quality Assurance Validation Specialist
- Successfully review, analyze, pre-underwrite and summarize originated loans to ensure underwriting and compliance guidelines were adhered to, along with requesting additional documentation.
- Assisted in the development and implementation of the validation process along with recognizing changing trends and incorporating those changes into the validation processes and procedures.
- Prepared monthly reports detailing errors, originator trends, RESPA tracking and losses and reporting these findings to management and compliance department.
- Mentor existing staff and participate in the training of new loan originators.
Candidate Info
7
years in workforce
6
months at this job
BA
Bachelor of Arts
Validation Specialist
Managing process for Mach 1 and Wiseguide catheter lines.
- Train line operators to identify conforming/non-conforming product.
- Quality review of catheter process documentations.
- Performed quality reviews for Design History Record (DHR) for final inspection line.
Candidate Info
9
years in workforce
2
years at this job
BS
Health Sciences
Validation Specialist / Corporate Trainer
- Audit patient records for missing or invalid documentation.
- Obtain missing or incomplete documentation for billing and reimbursement claims.
- Review, process and complete Medicare and RAC audits.
- Train and assist with Alabama Medicaid prior authorizations and appeals.
- Developed new workflow process to help establish accuracy, efficiency and productivity within the company.
Candidate Info
9
years in workforce
3
years at this job
AS
Life Science And Liberal Arts
BS
Biology
Validation Specialist
- Facilitate the development and implementation of commercially available Validation/Qualification protocols and documents as it relates to the Growth Direct System technology, microbial testing methods, automated Incubator temperature mapping and LIMs integration.
- Travel to customers sites to perform the IOPQ protocols to qualify the Growth Direct System for applications in the Pharmaceutical industry. This also includes training the appropriate personnel.
- Help support marketing by providing presentations of the Growth Direct System and products at promotional venues, scientific meetings and conferences.
- Execute activities such as technical support in troubleshooting, investigation and root cause analysis of customer complaints for product quality issues and concerns. All findings documented in Salesforce.
- Responsible for analyzing and presenting experimental data, document outcomes and conclusion in technical reports for peers, cross functional departments and senior management.