Compliance Specialist

CareAbout; Laval; Sur place; CAD 65 000 - 90 000; Plein temps

Avantages offerts par ce poste

Health insurance

Dental/Vision insurance

401(k) with employer match

Paid vacation/holidays

Telehealth programs

Résumé du poste

Altasciences in Laval, Canada seeks a Compliance Specialist to support the Bioanalytical Services group with regulated documentation and process improvements. The role collaborates across SOPs, templates, and external communications to ensure adherence to GLPs and regulatory guidelines.

The ideal candidate has a science background, CRO experience, and strong time management, with bilingual French/English communication skills.

Qualifications

• College degree in a sciences-related field; relevant 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 is an asset.
• Good knowledge of GLPs/SOPs and awareness of current regulatory guidelines (e.g. TPD, FDA, EMA).

Responsabilités

• 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 Bioplans, Validation Plans, Bioanalytical reports.
• Prepares appropriate responses for external messages to clients and regulatory agencies.
• Contributes to responses to letters of non-compliance, clarifaxes, deficiency letters, client audits and sponsor inquiries.
• Supports the management group as the BSD quality representative for internal procedures, documents and initiatives, to ensure that issues are properly handled through the corporate Quality Management System.
• Monitors and introduces new ideas of current topics based on 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.

Connaissances

Attention to detail

Organization

Interpersonal skills

Bilingual French/English

MS Office

Time management

Regulatory knowledge

Formation

College degree in sciences

Description du poste

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 Specialis t 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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