Compliance Specialist

Laval, QC
Hybrid
Posted Oct 9, 2026
1 position

Opens an external site

Employment type: Full-time
Experience level: Mid-level · 2+ years
Minimum education: Bachelor’s degree
Posting language: English
Working hours: 40 hours per week

Job summary

The Compliance Specialist supports the Bioanalytical Services department by managing regulated documentation and ensuring adherence to internal SOPs and regulatory guidelines. They also contribute to quality management initiatives, including responding to audits, deficiency letters, and monitoring new industry regulations.

Job details

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 You’ll 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 You’ll 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 #LI-MB1

What you’ll do

Requirements

The ideal candidate holds a college degree in a science-related field and possesses experience in a CRO environment specializing in bioanalytical assays. Proficiency in GLP/GCLP standards, excellent communication skills in both English and French, and strong organizational abilities are required.