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Adelina Kovacevic-Cosic
Moorhead,MN
Summary
Experienced leader in production and manufacturing operations, focusing on quality systems and team management.Improved operations and compliance with industry standards while leading cross-functional teams. Proficient in riskmanagement, material inspection, labeling and audit management, driving continuous improvement.
Overview
15
15
years of professional experience
Work History
Operational Quality Assurance Manager
Aldevron
Fargo, North Dakota
2020.11 - 2025.12
- Led cross-functional QA initiatives, including product audits, risk assessments, and validation activities to ensure compliance with cGMP and regulatory standards.
- Collaborated with cross-functional teams to resolve supplier performance and material quality issues, safeguarding continuity of supply in GMP manufacturing.
- Developed and optimized quality management systems and KPIs, reducing correction rates by 61% and deviations by 50%, while improving operational efficiency.
- Streamlined manufacturing quality processes, including real-time batch record review and 21 CFR-compliant labeling systems, significantly reducing turnaround time and errors.
- Reviewed and approved QA documentation (SOPs, deviations, CAPAs, change controls) while mentoring QA teams, enhancing compliance and promoting a strong quality culture.
Operational Quality Assurance Supervisor
Aldevron
Fargo, North Dakota
2019.10 - 2020.11
- Directed internal and external audits, inspections, and product release activities, ensuring adherence to specifications and regulatory compliance.
- Led and mentored QA teams across manufacturing, packaging, labeling, and warehousing operations, improving right-first time (RFT) performance.
- Analyzed performance data and resolved quality issues cross-functionally, implementing corrective and preventive actions (CAPAs) to improve product quality.
- Served as SME for deviations and excursions, conducting real-time batch record reviews and root cause analyses to reduce batch delays.
In-Process Quality Assurance Supervisor
Aldevron
Fargo, North Dakota
2018.05 - 2019.10
- Managed quality oversight of critical raw materials, including supplier-related quality issues, material release, and risk-based disposition decisions.
- Drove continuous improvement through root cause investigations, data analysis, and cross-functional collaboration.
- Collaborated directly with suppliers to resolve non-conformances and improve material quality, ensuring compliance with GMP requirements.
Plasma Center Assistant Manager
Biolife Plasma Services
Joplin, Missouri
2013.05 - 2018.05
- Oversaw daily donor center operations, ensuring compliance with cGMP, FDA, EMA, and internal standards.
- Implemented and monitored operational and quality KPIs, analyzing performance data to identify areas for continuous improvement.
- Led, coached, and developed cross-functional teams, enhancing staff capability, accountability, and operational efficiency.
Phlebotomy Safety Monitor III
PRACS Institute
Fargo, North Dakota
2011.01 - 2013.03
- Monitored and enforced safety compliance, enhancing protocols in clinical settings.
- Performed phlebotomy and specimen collection, ensuring adherence to safety standards and accurate documentation.
Education
Bachelor of Science - Microbiology
North Dakota State University
Fargo, NDSkills
- Quality management systems
- Cross-functional leadership
- Operational improvement
- Data analysis
- Training development
- Product Labeling
- Technical writing (CAPAs, deviation investigations, change controls, procedures, risk assessments)
- Root cause analysis and risk assessment
- Statistical Process Control
- Internal and external auditing
Affiliations
Cytiva SA25 Conference (aseptic filling workcell) in Vancouver, Canada - January 2025
Languages
Bosnian
Native/ Bilingual
Timeline
Operational Quality Assurance Manager
Aldevron
2020.11 - 2025.12
Operational Quality Assurance Supervisor
Aldevron
2019.10 - 2020.11
In-Process Quality Assurance Supervisor
Aldevron
2018.05 - 2019.10
Plasma Center Assistant Manager
Biolife Plasma Services
2013.05 - 2018.05
Phlebotomy Safety Monitor III
PRACS Institute
2011.01 - 2013.03
Bachelor of Science - Microbiology
North Dakota State University