Nada Ognen
Gahanna,OH
Summary
Experienced Documentation Senior Specialist adept at mentoring teams, conducting in-depth analysis, and implementing innovative solutions. Recognized for exceptional problem-solving abilities, strong communication skills, and commitment to quality and compliance.
Overview
15
15
years of professional experience
1
1
Certification
Work History
Sr. Specialist - QA Documentation
Hikma Pharmaceuticals
Columbus, OH
08.2023 - Current
- Authored and Reviewed Annual Stability Reports (ASRs),submitted to DRA for purposes of submission to the FDA via the Annual Report (AR)
- Performed regression analysis, long-term statistical analysis and long-term trend data review using Minitab of quality control (QC) stability results to predict future performance for purposes of the ASTR report
- Presented any observations to the Risk Assessment Team for evaluation and discussion. Completed any assigned action items from these meetings and presentation of the outcomes
- Performed periodic review of Standard Operating Procedures (SOPs), Work Instructions (WI), Forms, Templates via current document management system
- Trained and onboarded new hires in the QA - Documentation group
- Assigned monthly reports to team members.
- Attended professional development trainings: Crucial Conversations and Getting Things Done.
- Organized and maintained group spreadsheets for tracking purposes
- Completed Master Data Governance (MDG) QA Approval requests in SAP
Specialist II - QA Documentation
Hikma Pharmaceuticals
Columbus, OH
01.2018 - 08.2023
- Authored and Reviewed Annual Stability Reports (ASRs),submitted to DRA for purposes of submission to the FDA via the Annual Report (AR)
- Authored and Reviewed Annual Statistical Trending Analysis reports included in the Annual Product Review (APR)
- Reviewed Stability Commitment and Protocols (SC&Ps)
- Updated and routed specifications and analytical procedures for starting materials and finished products
- Attended filing checklist meetings as representative of QA - Documentation
- Completed White/Yellow Belt Projects to streamline Annual Stability Report process for electronic review and approval via current document management system
Specialist I - Documentation
Hikma Pharmaceuticals
Columbus, OH
02.2015 - 01.2018
- Authored Annual Stability Reports (ASRs),submitted to DRA for purposes of submission to the FDA via the Annual Report (AR)
- Authored Certificate of Analysis documents for filing documentation and batch release.
- Authored Stability Commitment and Protocols (SC&Ps)
- Updated and routed specifications and analytical procedures for starting materials and finished products.
Laboratory Technician III
Boehringer Ingelheim Pharmaceuticals
Columbus, OH
01.2014 - 02.2015
- Processed laboratory requests for samples and reagents
- Received samples in LIMS system
- Provided customer service and laboratory support
- Maintained inventory control via SAP
- Prepared swabs and mobile phase for cleaning validation support
Pharmacy Technician
Henry Ford Health System
Detroit, MI
03.2010 - 07.2013
- Processed new and refill prescription orders
- Maintained pharmacy inventory
- Returned damaged and defective products to manufacturers
- Delivered medications to patients on dialysis unit
- Prepared and submitted prior authorization forms to insurance companies on patient behalf
- Monitored workflow stations for optimum output
- Delegated daily work tasks to team members on behalf of pharmacy coordinator
Education
Master of Health Administration -
University of Phoenix
Tempe, AZ01-2012
Bachelor of Arts - English
Wayne State University
Detroit, MI01-2009
Skills
- Quality Assurance
- Attention to Detail
- Data Analysis
- Continuous Improvement
- Change Management
- Process Improvement
- Written Communication
- Change Control
- Document Coordinator
- Systems: SAP, Veeva Vault, TrackWise, Citrix, Adobe, MiniTab, Microsoft Office, LIMS
Certification
- Lean Six Sigma: Yellow Belt
Affiliations
- Grant Medical Center in Columbus, OH (08/2013 - 01/2014)
References
References available upon request.
Timeline
Sr. Specialist - QA Documentation
Hikma Pharmaceuticals
08.2023 - Current
Specialist II - QA Documentation
Hikma Pharmaceuticals
01.2018 - 08.2023
Specialist I - Documentation
Hikma Pharmaceuticals
02.2015 - 01.2018
Laboratory Technician III
Boehringer Ingelheim Pharmaceuticals
01.2014 - 02.2015
Pharmacy Technician
Henry Ford Health System
03.2010 - 07.2013
Master of Health Administration -
University of Phoenix
Bachelor of Arts - English
Wayne State University