- 847-***-****

- aczsxt@r.postjobfree.com

Quality Specialist

Qualifications Profile

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. Equipped with excellent leadership aptitude in performing multiple responsibilities and adeptness in ensuring strict compliance in fast-paced and demanding work environments. Armed with outstanding interpersonal and communication skills; combined with problem-solving and time management abilities.

Core competencies include:

Corrective and Preventative Action (CAPA) Data Analytics Cross-functional Collaboration Problem Resolution

Reports and Documents Generation Regulatory Compliance Staff Training and Development

Professional Experience

Quality Assurance Manager Jun 2015–Present

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

PARAXEL International Deerfield, IL

Senior Project Quality Lead Apr 2014–Jun 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 Feb 2009–Apr 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

Angiotech/Manan Medical Products Wheeling, IL

Quality Complaint Analyst Feb 2008–Jan 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

Fenwal Blood Technologies Lake Zurich, IL

Quality Associate II Mar 2007–Feb 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 in Communication, In Progress (Estimated Completion Date: 2018)

McHenry County College Crystal Lake, IL

Colorado State University Global Campus Greenwood Village, CO

Associate of Science in General Science Classes

McHenry County College Crystal Lake, IL

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