Donna Leturno
Round Lake,Illinois
Summary
Highly committed, seasoned, and multifaceted professional, offering distinguished career in quality control within the pharmaceutical industry. Recognized for handling various tasks and projects, while ensuring on-time delivery. Excellent leadership aptitude in performing multiple responsibilities and adeptness in ensuring strict compliance in fast-paced and demanding work environments. Outstanding interpersonal and communication skills; combined with problem-solving and time management abilities.
Overview
17
17
years of professional experience
Work History
Senior Certification Office Associate
UL Solutions
01.2018 - Current
- Internal program review requests improved from 3 days to 1 day.
- Communicated program requirements to global team members to improve department consistently and turn around time.
- Update trainings for program requirements to improve consistency in deliverables globally.
- Update SOPs and policies to ensure efficient and streamlined workflow.
Quality Assurance Manager
GlobalCare Clinical Trials, Ltd.
06.2015 - 01.2018
- Manage all quality assurance-related activities, including identifying, tracking, and resolving quality issues, while adhering to regulatory compliance including good clinical practice (GCP), good documentation practices (GDP), and good manufacturing practice (GMP) requirements, and agreements with clients
- Oversee clinical trial study project management along with the reporting of quality issues and metrics
- Expertly plan and implement new procedures for smooth and efficient operations
- Conduct and facilitate internal assessment in evaluating projects and associated risks
- Take charge of approving, reviewing, and routing controlled documentations including client facing documents
- Hold responsibility in gathering and producing key performance indicators (KPIs) to be reported to the executive staff, while participating in key internal project team meetings
- Observe strict adherence to the International Conference on Harmonization (ICH) guidelines and Good Clinical Practices
- Facilitate and conduct compliance training for all employees annually.
Senior Project Quality Lead
PARAXEL International
04.2014 - 06.2015
- Rendered exceptional support to project teams by identifying and resolving issues, while providing consultation regarding corrective and preventive actions
- Spearheaded team discussions and investigations into non-compliances, which include root cause and preventive actions
- Collaboratively worked with the project team management and other relevant parties in determining and assessing potentials risks to conduct appropriate mitigation measures
- Assumed accountability in handling project quality activities and management, while closely working with cross-functional teams to maintain outstanding customer service
- Implemented quality evaluations for assigned projects, while maintaining adherence to GxP guidelines and regulations, procedures, and sponsor requirements
- Offered support to the Project Team by conducting audits and inspection for assigned projects, while providing feedback and recommendation upon reviewing
- Maintained active involvement in key internal project team meetings to effectively discuss matters concerning quality management, while overseeing the collection of reports for project quality metrics.
Project Quality Lead II
PARAXEL International
02.2009 - 04.2014
- Carried out quality gates and interventions and conveyed results to team members to ensure strict compliance with procedure requirements
- Effectively prioritized and spearheaded a broad range of responsibilities including client communication according to CAPA investigation; project quality activities; as well as internal, client, and ISO audits
- Facilitated and conducted training to new employees, focusing on the quality management systems and GxPs requirements and standards
- Assisted staff and team member on any concerns regarding standard operating procedures (SOP) deviations and quality issues
- Administered the quality management system documentation including SOPs, policies, quality manuals, forms and templates, and work instructions.
Quality Complaint Analyst
Angiotech/Manan Medical Products
02.2008 - 01.2009
- Performed wide range of duties such as minimizing the cycle time in opening complaint files; investigating, documenting, and resolving internal and external customer complaints; as well as facilitating procedural training for manufacturing employees
- Took charge of issuing accurate change request tracking number while retaining history files.
Quality Associate II
Fenwal Blood Technologies
03.2007 - 02.2008
- Proactively participated in Voice of the Customer project to gain more knowledge on customer needs and challenges, while enhancing and streamlining procedural operations
- Accurately recorded all investigation plans and complaints information while resolving all internal and external concerns and issues.
Education
Bachelor of Science, Communication -
Colorado State University Global Campus
Greenwood Village, COAssociate of Science, General Science Classes -
McHenry County College
Crystal Lake, ILSkills
- Document Control
- Corrective and Preventative Action (CAPA)
- SOP Management
- Cross-Functional Team Leadership
Timeline
Senior Certification Office Associate
UL Solutions
01.2018 - Current
Quality Assurance Manager
GlobalCare Clinical Trials, Ltd.
06.2015 - 01.2018
Senior Project Quality Lead
PARAXEL International
04.2014 - 06.2015
Project Quality Lead II
PARAXEL International
02.2009 - 04.2014
Quality Complaint Analyst
Angiotech/Manan Medical Products
02.2008 - 01.2009
Quality Associate II
Fenwal Blood Technologies
03.2007 - 02.2008
Bachelor of Science, Communication -
Colorado State University Global Campus
Associate of Science, General Science Classes -
McHenry County College