Compliance Specialist

Your New Company
At Altasciences we all move in unison to assist and work in the discovery, development, and manufacturing of new drug therapies to get them faster to people who need them. No matter your role, we all play an important part and you will have a significant impact on the health and well-being of people across the globe. By living our values of Employee Development, Customer Focus, Quality and Excellence, Respect and Integrity, we look to foster a passionate and collaborative work environment and we are looking for talented and enthusiastic people, like you, to join our growing team Whether you’re a recent college graduate or seeking your next career opportunity, it’s time to discover your future at Altasciences. We are better together and together We Are Altasciences.

About The Role

As a Compliance Specialist, you will work with internal and external stakeholders and support the regulated bioanalytical teams. We are looking for Scientist or Technical lead looking to transition from bioanalytical study management/execution to a supporting role.

What You'll Do Here

Based on competency and training, the compliance specialist would be assigned different tasks.
- 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;
- 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 as a quality representative person for internal procedures, documents and initiatives, to ensure that issues of concern are properly handled;
- 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;
What You'll Need to Succeed
- Minimum of a College degree or equivalent in a science-related field. Pertinent experience may be considered in lieu.
- Experience in a CRO specializing in LC-MS work and/or bioanalytical are an asset.
- Good knowledge of GLPs/SOPs and awareness of current regulatory guidelines (e.g. TPD, FDA, EMA, etc.).
- Bilingualism (excellent written/oral communication skills in French and English).
- Attentive to details.
- Good organizational and interpersonal skills.
- Proficiency MS Office
- Excellent planning and time management skills

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
- Telework when applicable

**Altasciences’ Incentive Programs Include**:

- Training & Development Programs
- Employee Referral Bonus Program
- Annual Performance Reviews

MOVING IN UNISON TO DELIVER A BIG IMPACT WITH A PERSONAL TOUCH

Altasciences is an equal opportunity employer committed to diversity and inclusion. Our goal is to attract, develop and retain highly talented employees from diverse backgrounds, allowing us to benefit from a wide variety of experiences and perspectives. All qualified applicants will receive consideration for employment without regard to age, race, color, religion, creed, sex, sexual orientation, gender identity, national origin, disability or any other protected grounds under applicable legislation. Reasonable accommodations for persons with disabilities during the recruitment process are available upon request. Join us at Altasciences