Quality Control Data Entry

Kasey Travers

973-***-**** ******@*****.***

Lake Hopatcong, NJ

Overview

I have worked in the Quality Control Unit in both Non-Clinical and Clinical drug development research facilities for over 20 years; collaborating cross-functionally and collaboratively with all Quality Units including Regulatory Affairs and tightly with the Quality Assurance Departments. Reviewing data and maintaining accurate and current records has been an integral part of my work ethic and passion for the patients and efficacy of the medications or products manufactured. Work Experience

Instem Sept. 2021 – Oct. 2024

Team Lead/Senior Information Scientist

• Demonstrated an in-depth understanding of pre-clinical data, SEND and other regulatory standards/guidance.

• Performed Quality Control and Conformance reviews of preclinical data converted into SEND created internally or provided by outside CROs.

• Acted as a functional expert on SEND specified data files and quality control practices.

• Actively participated in CDISC Dermal/Ocular Sub-team.

• Mentored, managed, and trained direct reports and new hires, as well as provided guidance to senior management on best practices for team relationships and professional development trainings for entire team.

• Ensured the operational effectiveness and excellence of the SEND Express business unit.

• Tracked and analyzed trends, along with proposals for process improvement plans.

• Worked directly with project management, resource management, and project members to ensure timelines and quality standards were met and remained consistent.

• Created working documents for conformance projects with QA review.

• Generated SEND datasets using Submit and Provantis software systems.

• Remained current with SEND best practices and was responsible for comparison of created files against reports.

PDS Life Sciences (acquired by Instem) Aug. 2019 – Oct. 2021 Senior SEND Reviewer Jan. 2020 – Oct. 2021

• Mentored and trained SEND Review new hires, alongside providing guidance to senior management on best practices in team relationships and professional development training for entire team.

• Performed Quality Control and Conformance on SEND Datasets created by team or outside clients as a quality control specialist.

• Ensured the operational effectiveness and excellence of the SEND Express business unit, and acted as an expert on SEND specified data files and quality control practices.

• Tracked and analyzed trends and was involved with process improvement plans.

• Worked directly with project management members to ensure timelines and quality standards were met and remained consistent.

• Created working documents for conformance projects with QA review. Send Review Aug. 2019 – Jan. 2020

• Generated SEND datasets and was responsible for verification of data entry from the team.

• Performed Quality Control on SEND datasets created by SEND Express team.

• Remained current with SEND best practices and comparison of created files against reports. Immunomedics Sept. 2005 – Apr. 2019

Microbiology Manager Aug. 2012 – Apr. 2019

• Responsible for screening and interviewing potential candidates and was in charge of establishment/maintenance of training curriculum for microbiology employees.

• Identified performance expectations and provided ongoing feedback for direct reports, alongside timely and appropriate corrective/disciplinary action with employees when necessary.

• Managed five Microbiologists and four Microbiology Technicians by setting priorities and directed daily activities, including environmental monitoring, sampling and testing in-house Pharmaceutical Grade Water Systems, growth promotion, bioburden testing, etc.

• Authored and supervised execution of facility EMPQ protocols and reports.

• Reviewed, approved, and released of Quality Control Testing results.

• Coordinated all contracted microbiological testing such as sterility, mycoplasma, and identifications.

• Facilitated cleanroom behavior training and etiquette for all employees.

• Generated suitability reports for bioburden and endotoxin testing.

• Investigated and generated non-conformance and out-of-specification/out-of-trend reports.

• Generated and approved change controls and work orders

• Assisted in developing risk assessments, developed and maintained SOPs and other protocols, and assisted in the development and implementation of method validations based on FDA, EMA and ICH guidelines.

• Collaborated with Regulatory department to support fillings/amendments and annual reports.

• Assisted in audits and inspections from FDA, EMA and other regulatory agencies. Microbiology Supervisor Aug. 2009 – Aug. 2012

• Performed internal inspection/audits of the laboratory in preparation of regulatory or FDA/EMEA inspections.

• Conducted and managed laboratory investigations, participated as Microbiology during investigations into deviations/exceptions., CAPA, OOS, Change Controls, NCRs, and environmental monitoring excursions

• Set goals and conducted performance reviews of direct reports, and performed ongoing assessments of development and training needs of reporting staff to ensure continued development of personnel.

• Auditor of raw data, and authored and revised departmental SOPs, MSSs, Protocols and Batch Records.

• Continuously implemented improvements within the Microbiology Department to optimize the data management, system performance, budget preparation, and resource allocation for the Quality Control unit. Microbiologist Sept. 2005 – Aug. 2009

• Involved with environmental monitoring, alongside sampling and testing of the in-house Pharmaceutical Grade Water systems. Growth Promotion

• Worked closely with Sterility BacT/Alert 3D System, bioburden, endotoxin, and biological indicator testing. Cardinal Health Mar. 2003 – Aug. 2005

Microbiology Lab Technician

• Audited raw and finished data, trained new and relocated employees in cGMP and GLP methods, as well as provided support by testing samples from other internal customers including validation and R&D.

• Participated in sampling and testing of in-house Pharmaceutical Grade Water Systems, environmental monitoring, as well as media preparation and growth promotion. American Instants July 2001 – July 2002

Quality Control Manager Sept. 2001 – July 2002

• Performed daily internal audits and oversaw plant procedures (packaging lines and blending).

• Prepared and presented cGMP lectures and trainings to staff members.

• Assisted with Research and Development to match new products. Lab Technician July 2001 – Sept. 2001

• Performed QC testing on raw materials before use in production, including taste testing in various applications, appearance, odor, percent moisture, pH, bulk density, and sieve analysis. Gibraltar Biological Laboratories Mar. 2000 – July 2001 Entry Level Microbiologist

• Responsible for bioburden testing, sampling and testing of Pharmaceutical Grade Water, and environmental monitoring.

• Followed USDA regulations for animal care and upkeep, health surveillance, pain assessment, cage side observations, and assisted with animal preparation and handling for surgery.

• Conducted mouse oral safety test with proficiency. EDUCATION

Montclair State University Graduated May 2012

Bachelor of Science in Biology

County College of Morris Graduated Jan. 2000

Associate of Science in Biology

SKILLS

Microsoft Office Applications

LIMS

GEMS

PUBLICATIONS

Luis Jimenez, Narendra Rana, Kasey Travers, et al. Evaluation of the Endosafe® Portable Testing System for the Rapid Analysis of Biopharmaceutical Samples. PDA J Pharm Sci and Tech 2010, 64 211-221.

Jimenez, L., Rana, N., Amalraj, J., Travers, K. "Validation of the BacT/Alert 3D System for Rapid Sterility Testing of Biopharmaceutical Samples." PDA Journal of Pharmaceutical Science and Technology, 2012 Jan 1, 66 (1): 38-54

Jimenez, L., N. Rana, K. Travers, O. Santiago, J. Amalraj, and K. Walker. 2012. Rapid Quantitative Endotoxin Analysis of Biopharmaceutical Samples Using the Endosafe Multi-Cartridge System. American Pharmaceutical Review. In Press.

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