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Validation Specialist Resume Samples
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0-5 years of experience
- 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.
0-5 years of experience
- 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.
0-5 years of experience
- 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.
0-5 years of experience
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.
0-5 years of experience
- 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.
0-5 years of experience
- 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.
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[Validation Specialist]
Last edited by: Gabriela Barcenas, CPRW, Content Writer II -
Gabriela Barcenas
CPRW, Content Writer IIGabriela is a Certified Professional Resume Writer (CPRW) and career adviser. With 10 years of digital media experience and five years of resume writing expertise, her publication history includes fashion, education, travel, social justice, equitable design and career advice.
