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Added 2 mins ago
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Altasciences

Compliance Specialist

Laval, QC, Canada

Full-time

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Job details

Job type: Full-time
Posting language: English
Posted: Sep 1, 2026

Original job description

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

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More about this job

Responsibilities

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.

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.

Skills

Compliance
SOP development
Regulatory guidelines
Bioanalytical services
Quality management system
GLP
GCLP
Ligand binding assay
Immunogenicity assay
LCMS
Technical writing
Data analysis
Time management
Interpersonal skills
Bilingualism
MS Office

Benefits

Health insurance
Dental insurance
Vision insurance
401(k)
RRSP
Employer match
Paid vacation
Paid holidays
Paid sick leave
Bereavement leave
Employee assistance program
Telehealth programs
Training and development programs
Employee referral bonus program

Visa sponsorship

Not detected in the job text

Keywords

Compliance
Bioanalytical Services
SOP
GLP
GCLP
LBA
ADA
LCMS
CRO
Quality Management System
Regulatory Affairs
FDA
EMA
TPD
Technical Writing
Data Trending
Audit Support
Bioplans
Validation Plans
MS Office
Bilingual
Science
Documentation
Quality Assurance

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