Quality Control Specialist - Mississauga, Canada - Cliantha Research Ltd.

Cliantha Research Ltd.

Verified Company

Mississauga, Canada

2 weeks ago

Posted by:

Sophia Lee

beBee Recruiter

Description

General Responsibilities:

Perform quality control procedures for clinical trials managed by the Clinical Operations department; review all study documentation for accuracy, consistency and completeness
Work with QC manager, Clinical Operations management and study management staff to create study specific QC plans that outline the scope of quality control procedures to be followed during clinical trials, ensuring QC processes are in alignment with Cliantha SOPs and study protocols
Work with the QC manager to schedule live and postvisit QC activities to ensure that all requirements of the QC plan are executed
Assist with the development of; and utilize QC checklists and other QC tools designed to document/track the QC review process
Communicate findings from QC reviews to the appropriate Clinical Operations staff via QC summaries, reports or verbally as required.
With some guidance, followup on all QC findings, as required, until a satisfactory resolution has been determined
Assure documentation review meets or exceeds designated timeline parameters
Maintain a working knowledge of relevant Canadian GxP regulations as well as ICH regulations
Ensuring training file and SOP reading is maintained and up to date
Actively participates and assists in all team study activities and conduct with a willingness to learn
Ensure compliance with appropriate Cliantha SOP's, GCP and ICH guidelines
Participate in training sessions
Execute other duties as may be required by the Manager and other members of Cliantha Research Management team as training and experience allow

Qualifications:

Bachelor degree, with a minimum of two years of college, university, or technical school education in life science or relevant scientific discipline.
Ability to use computers and software associated with their job function (e.g. Microsoft Excel, Word and Outlook)
12 years of relevant experience in a clinical research setting
Strong eye for detail and ability to spot inconsistencies a must
Good conflict management skills
Displays a basic ability to identify, anticipate and define issues in a timely manner and to understand the potential impact of issues. Sufficient awareness to notify a supervisor when the problem is beyond the individual's ability to resolve, or as otherwise appropriate.
Displays some analytical and problem solving skills and the ability to present solutions
Excellent organizational skills, detail oriented, efficient and able to multitask and prioritize effectively
Excellent interpersonal skills
Strong written and verbal communication skills

Schedule: