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Quality Assurance

Location:
Suwanee, Georgia, 30024, United States
Posted:
April 21, 2017
Email:
aczw2g@r.postjobfree.com

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Valarie Paquin

*** ****** ******* ***** *******, GA 30024

470-***-**** aczw2g@r.postjobfree.com

Clinical Site Technician

A Recognized Expert in Regulations and Compliance in a Pharmaceutical Setting

Comprehensive background in ensuring that all reports, information, and operations are within the parameters of all relevant standards and policies. Skilled in locating areas of non-compliance and rapidly constructing the strategies necessary to solve the issue. A skilled communicator who facilitates the creation and maintenance of long term professional relationships.

CORE COMPETENCIES

Compliance Assurance Regulatory Knowledge Customer Relationships Quality Assurance

Team Management Effective Communication Interpersonal Skills Process Improvement

Drug Process GCP/ICH Guidelines Clinical Trial Process Time Management Organizational Skills

Regulatory Submission Documentation (CTA, NDS, SNDS, ANDS, CTD, and QOS) Documentation

EXPERIENCES AND ACHIEVEMENTS

CP Medical, Norcross, GA February 2017-April 2017

Quality Assurance (Contract Position)

A broad knowledge of medical device and quality systems regulations.

Extensive experience with researching and solving quality complaints using CAPAs, NCMRs and DHR reviews.

Posses the knowledge and ability to develop and administer management information systems to audit quality systems for deficiencies

Reporting on complaint metrics to review and follow-up issues.

Researched, investigated and closed over 860 quality complaints in two months

Atlanta, GA October 2011-February 2017

Immigrated to the United States of America. While waiting for my green card took time to care of my family. Ready to enter the workforce.

Apotex, Inc., Toronto, Ontario November 2001 – September 2011

Clinical Site Technician April 2011 – September 2011

Played a key role in a multi-disciplined team of healthcare providers tasked with providing timely support for Apotex products by serving as the departmental contact for all issues relating to Health Canada’s Special Access Program (SAP).

Fostered positive relationships with internal and external stakeholders through the use of expert interpersonal and communication skills.

Ensured the high level of integrity and security for the Pharmacy Vault contents by regularly assessing current strategies and operations to locate any areas of improvement.

oProvided archival control for Clinical Test Articles.

Minimized any chance of mistake or false results through the regular maintenance and calibration of clinical equipment and the transfer of biological samples.

Coordinator – Drug Information April 2006 – April 2011

Consistently generated positive experiences through the timely response to any requests for information and enquiries from both internal and external sources.

Directly oversaw all end to end management, coordination, and execution of non-marketed products through Health Canada’s Special Access Program (SAP) through the use of expert time management and organizational skills.

oPerformed confirmation and preparation for special access requests upon authorization by TPD under SAP.

oLeveraged prior experience and training to serve as the primary liaison to Health Canada for the SAP Program.

oVerified the accuracy and entry of all data prior to tracking through the IRMS database.

Ensured the creation of positive customer relationships by serving as the key liaison for all Quality Assurance.

oAddressed all quality complaint issues in a timely manner while facilitating the quality complaint process through the collection of all relevant data.

oProvided absolute adherence to all SOP/GMP guidelines and regulations.

Further served as the key liaison with Drug Safety to ensure proper follow-up.

Remained up to date with all new policies regarding Canadian Food and Drugs Regulations as well as all relevant guidelines.

Minimized the risk of any deviation from regulations and policies by ensuring all QA and Drug Safety investigations and follow-up results were accurately incorporated into the IRMS database.

Had training delivered by drug Safety/Quality Assurance with regards to possible ADRs/QC to ensure proper information was recorded in our database.

oTraining encompassed reporting guidelines appropriate to specific regulatory authority.

Responsible for monthly VP/CEO reports used to account for incidents regarding ADR’s/QC and general inquiries.

oRaw reporting data was analyzed to provide focus items for senior leadership.

Additional reporting was provided to Health Canada for the Special Access Program.

Able to work with various departments to acquire information necessary to resolve customer inquiries and management escalations.

Administrator – Professional Affairs May 2003 – April 2006

Provided responses to requests for information from both internal and external sources. Played a key role in the preparation of PowerPoint presentations.

Coordinated the logistics for event tracking and deliverables concerning multiple ongoing projects.

oUtilized time management skills to ensure all goals were met and delivered within the tight time constraints.

Representative – Order Process November 2001 – May 2003

Handled high volumes of inquiries and requests via telephone to ensure positive customer and company experiences. Oversaw all case study requests sent to the customer service from Drug Information. Served as the key contact for drug recall enquiries while managing all associated returns.

Due to excellent level of work and understanding of the company’s goals, promoted from a contract position to a permanent position within 3 months.

Maximized overall awareness for the order desk concerning the current status of all agents by initiating an innovative policy change.

Created a more effective and even distribution for all electronic requests received from sales representatives.

Canada Customs and Revenue Agency, Ottawa, Ontario February 2000 – September 2001

Data Entry/Customer Service Agent

Handled all aspects of a high volume business environment including the repeated completion of projects within strict timelines on a daily basis.

Resolved any customer issues while deescalating situations with irate customers.

EDUCATION

Graduate Certificate, Pharmaceutical Regulatory Affairs and Quality Operations

Seneca College, Toronto, Ontario, 2007

Graduated with honors.

Bachelor of Science, Biochemistry, Carleton University, 1999



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