Organized and dependable candidate successful at managing multiple priorities with a positive attitude. Willingness to take on added responsibilities to meet team goals. Excellent time management and problem-solving skills. Known for reliability and adaptability, with swift capacity to learn and apply new skills. Eager to contribute to team success and further develop professional skills.
Overview
9
9
years of professional experience
Work History
Quality Control Technical Writer
Gilead Via Actalent (Contract)
07.2021 - 05.2024
Proved successful working within tight deadlines and a fast-paced environment
Managed 800+ quality control documents and specifications
Managed version control and timely updates of documents through effective project tracking and organization skills
Conducted thorough document reviews to identify inaccuracies, inconsistencies, or areas needing clarification
Coordinated with subject matter experts to ensure accuracy of technical content in documentation projects
Ensured regulatory compliance by keeping abreast of industry standards and updating documentation accordingly.
Served as liaison between various teams and non-technical stakeholders, ensuring seamless communication throughout project lifecycles.
Collaborated with cross-functional teams to gather information for accurate and comprehensive documentation.
Implemented feedback from end-users to continuously improve quality and effectiveness of documentation materials
Proofread copy written by colleagues to correct spelling, punctuation, and grammar
Weekly reporting via Microsoft Excel
Facilitated committee for internal analytical changes (monthly meetings - hosted, took minutes, etc)
QA Specialist
ImaginAb Inc
11.2020 - 07.2021
Ensured compliance with industry standards and regulations through diligent adherence to established QA procedures and guidelines.
Streamlined QA processes by developing and implementing electronic systems, increasing overall team efficiency.
Educated employees on specific QA standards and confirmed maintenance of standards
Interpreted test results by comparing to established specifications and control limits, making recommendations on appropriateness of data for release (Batch Record Review)
Act as reviewer and auditor for operational SOPs, Work Instructions, and vendors, including any follow-up; assist in writing SOPs as needed
Initiate, execute, and track completion of Change Control, Non-Conformance and CAPA requests
Quality Control Specialist II, Microbiology (Contract)
Aerotek
06.2020 - 11.2020
Created and maintained trending database for regular reporting (Excel)
Ensured compliance with all local and international regulatory requirements
Initiated process improvements that led to reduced waste and increased production efficiency.
Provided regular updates to team leadership on quality metrics by communicating consistency problems or production deficiencies.
Enhanced product quality by implementing rigorous testing procedures and identifying areas for improvement.
Maintained up-to-date knowledge of industry best practices, sharing insights with colleagues to foster continuous learning among team members.
Consultant
ProPharma Group
08.2019 - 06.2020
Procedure remediation and updates per client request
Train and oversee personnel executing testing for protocol studies
Evaluated client needs and expectations, establishing clear goals for each consulting engagement
Collaborated with cross-functional teams to successfully deliver comprehensive solutions for client
Managed client relationships through regular check-ins and updates on project progress
Delivered high-quality presentations to stakeholders, effectively communicating project objectives and results
Microbiologist II
Gilead c/o Aerotek
10.2015 - 08.2019
Enhanced laboratory efficiency by streamlining sample processing and implementing new testing procedures
Collaborated with interdisciplinary teams to develop innovative solutions for complex microbiological challenges
Increased accuracy of test results through meticulous attention to detail during data analysis and interpretation
Carried out studies to support commissioning of new facility and equipment while meeting tight approval deadlines
Author and execute protocols and edit/maintain compliance of SOPs
Scheduled and trained technical staff members
Ensured compliance with regulatory standards by maintaining detailed records of laboratory procedures and results
Education
Bachelor of Arts - Biology
University of Redlands
Redlands, CA
05.2009
Skills
Multitasking
Teamwork and Collaboration
Time Management
Attention to Detail
Organizational Skills
Effective Communication
Self Motivation
Analytical Thinking
Continuous Improvement
Adaptability
Additional Information
References available upon request.
Timeline
Quality Control Technical Writer
Gilead Via Actalent (Contract)
07.2021 - 05.2024
QA Specialist
ImaginAb Inc
11.2020 - 07.2021
Quality Control Specialist II, Microbiology (Contract)
Aerotek
06.2020 - 11.2020
Consultant
ProPharma Group
08.2019 - 06.2020
Microbiologist II
Gilead c/o Aerotek
10.2015 - 08.2019
Bachelor of Arts - Biology
University of Redlands
Similar Profiles
Michelle McCormickMichelle McCormick
Quality Specialist II at Actalent/Gilead SciencesQuality Specialist II at Actalent/Gilead Sciences