Compliance Specialist
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Job Summary
About The Role
The Compliance Specialist is responsible to support the Bioanalytical Services department (MS and LBA) in regards to regulated documentation pertaining to the Bioanalytical Services department. The Compliance Specialist is also a resource to the team for related tasks.
What Youll Do Here
Based on competency and training the compliance specialist would be assigned different tasks. Examples of these tasks include.
To write/revise general SOPs in accordance with regulatory guidelines and internal procedures.
To write/revise/update templates to be in accordance with internal SOP procedures and regulatory guidelines including but not limited to Bioplans Validation Plans Bioanalytical reports.
Prepares appropriate responses for external messages to clients and regulatory agencies.
Contributes to responses to the letters of non-compliance clarifaxes deficiency letters client audits and sponsor inquiries.
Supports the management group as the BSD quality representative person for internal procedures documents and initiatives to ensure that issues of concern are properly handled through the corporate Quality Management System.
Monitors and introduces new ideas of current topics based on different associations/organizations/conferences and new regulations to the management.
To perform and present trending reports to management based on information gathered from trending analysis throughout the department using various database systems.
To conduct all work in compliance with SOPs GLPs GCLPs and observe all company guidelines and policies.
What Youll Need to Succeed
Ideally a College degree in a Sciences related field. Pertinent experience may be considered in lieu.
Experience in a CRO specializing in ligand binding assay (LBA) immunogenicity assay (ADA) and LCMS innovator drug study work and/or bioanalytical are an asset.
Good knowledge of GLPs/SOPs and awareness of current regulatory guidelines (e.g. TPD FDA EMA etc.).
Attentive to details.
Good organizational and interpersonal skills.
Bilingualism (excellent written/oral communication skills in French and English).
Proficiency MS Office.
Excellent planning and time management skills
Altasciences strives to provide a French work environment for its employees in Quebec. Altasciences has taken all reasonable measures to avoid imposing the above language requirement. This requirement is essential for the position of Compliance Specialist in particular but without limitation for the following reason(s):
The requirement to have study protocols read and documented in English as required by industry regulatory agencies
What We Offer:
Altasciences offers a wide variety of benefits to help our employees live healthy and fulfilling lives both at and outside of work.
Altasciences Benefits Package Includes:
Health/Dental/Vision Insurance Plans
401(k)/RRSP with Employer Match
Paid Vacation and Holidays
Paid Sick and Bereavement Leave
Employee Assistance & Telehealth Programs
Altasciences Incentive Programs Include:
Training & Development Programs
Employee Referral Bonus Program
Annual Performance Review
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Required Experience:
IC
About Company
Contract research organization specialized in seamless, end-to-end, early phase drug development, we act to get your most promising compounds into and through early phase clinical trials.
