At a Glance
- Tasks: Support Bioanalytical Services by managing compliance documentation and regulatory responses.
- Company: Join Altasciences, a leader in bioanalytical services with a focus on quality and innovation.
- Benefits: Enjoy health benefits, paid vacation, and a supportive work environment.
- Other info: Dynamic workplace with opportunities for training and career growth.
- Why this job: Make a real impact in the biotech field while developing your skills in compliance.
- Qualifications: College degree in Sciences or relevant experience; knowledge of GLPs/SOPs is a plus.
The predicted salary is between 62100 - 75900 $ per year.
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.
- Write/revise general SOPs in accordance with regulatory guidelines and internal procedures.
- 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.
- Prepare appropriate responses for external messages to clients and regulatory agencies.
- Contribute to responses to letters of non-compliance, clarifications, deficiency letters, client audits and sponsor inquiries.
- Support 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.
- Monitor and introduce new ideas of current topics based on different associations/organizations/conferences and new regulations to the management.
- Perform and present trending reports to management, based on information gathered from trending analysis throughout the department using various database systems.
- 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 in MS Office.
- Excellent planning and time management skills.
What We Offer:
- 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
Compliance Specialist in Laval employer: CareAbout
Altasciences is an exceptional employer located in the vibrant city of Montreal, offering a dynamic work culture that prioritizes safety and patient care. Employees benefit from comprehensive training programs, opportunities for professional growth, and a supportive environment that fosters collaboration and innovation. With a commitment to excellence in clinical research, Altasciences provides a meaningful and rewarding career path for those passionate about making a difference in healthcare.
