Aieman Zehra
Tampa,FL
Summary
Organized and dependable candidate successful at managing multiple priorities with a positive attitude. Willingness to take on added responsibilities to meet team goals.
Overview
8
8
years of professional experience
17
17
years of post-secondary education
Work History
Quality Specialist III-Quality Improvement(Remote)
BioReliance Corporation
Rockville, MD
08.2021 - Current
- Lead process improvement projects to ensure consistency and compliance with quality and business requirements across multiple sites
- Participate in global projects and Quality Excellence initiatives as a Quality subject matter expert and drive discussions to build consensus across the business regarding Quality topics
- Support the maintenance of quality management system and processes
- Lead as process owner for general control process management for the site and make process improvements as necessary
- Improve quality processes for increased efficiency and effectiveness.
- Review and approve global standard operating procedures (SOPs), deviations, applicable CAPAs, effectiveness checks and general change control records
- Provide guidance and support to stakeholders for initiation of deviations, CAPAs, and Change Controls
- Support in conducting root cause analyses using methodologies, e.g Fishbone, 5 whys, comparative analysis, etc
- Support the collection, preparation, and management of Quality Systems metrics in support of Quality Management Review
Quality Specialist II-Audits
BioReliance Corporation
Rockville, MD
11.2017 - 07.2021
- Review and approve validation files for systems and assays
- Review and approve standard operating procedures (SOPs), laboratory / batch records, deviations and other quality records
- Review and approve study files against regulatory and internal requirements to include protocols, technical specifications, raw data, final reports, cell banking production records, and certificates of analysis
- Conducts inspections for labs supporting GMP manufacturing and assist with GMP manufacturing operations
- Interact with other departments to ensure compliance with internal procedures and FDA regulations
- Provides compliance support of quality systems including: deviations, CAPAs and change controls
Product Specialist
AK Scientific Inc
Union City, CA
09.2014 - 10.2017
- Manage the quality complaint handing process and determine corrective action
- Maintain product knowledge in company database and contribute regularly to process excellence
- Liaise between business and technical personnel to ensure a mutual understanding of processes and applications
- Establish pricing structures for product lines and services
- Liaise between clients’ end-users and product development team to recommend product enhancements
- Organize and conduct data management activities, such as data file transfers, data review, resolution of data discrepancies, data import and export within inventory software and database
- Identify process problems and implemented new and improved policies and processes
- Provide input into developing and modifying systems to meet client needs and develop business specifications to support these modifications
Education
Bachelor of Arts - Biology Sciences
University of California, Santa Cruz
Santa Cruz, CA 05.2001 - 05.2016
Master of Science - Biotechnology
University of Maryland
08.2021 - 06.2023
Skills
Corrective actions
Trackwise
Quality processes
Root Cause Analysis
Continuous Process Improvement
Timeline
Master of Science - Biotechnology
University of Maryland
08.2021 - 06.2023
Quality Specialist III-Quality Improvement(Remote)
BioReliance Corporation
08.2021 - Current
Quality Specialist II-Audits
BioReliance Corporation
11.2017 - 07.2021
Product Specialist
AK Scientific Inc
09.2014 - 10.2017
Bachelor of Arts - Biology Sciences
University of California, Santa Cruz
05.2001 - 05.2016