Compliance Specialist

Laval, QC, Canada Req #1168
Tuesday, December 1, 2020

Altasciences is a mid-size contract research organization with a unique focus on supporting drug development from lead candidate selection to proof of concept. With over 25 years of industry experience, we provide preclinical and clinical solutions to an international customer base of biopharmaceutical companies. Our full-service offering in this critical stage of drug development includes program management, preclinical safety testing, clinical pharmacology services, manufacturing and analytical services, medical writing, biostatistics, data management, and bioanalysis services tailored to specific research requirements. Altasciences has facilities in Montreal, QC; Kansas City, KS, Seattle, WA, and Philadelphia, PA.

Our team is made up of over 1,300 professionals from the medical and scientific fields who work together to
achieve a common goal: to contribute to the advancement of life sciences. Bring your talents and forward-thinking approach to Altasciences and help us develop medicines for those who need them, faster.

Are you looking for an opportunity to support a business creating life-saving treatments? Our opportunity will surely interest you! Joining a fast-growing contract research organization, you will have the opportunity to develop your skills. If you stand out for your organizational skills and your attention to details; don't hesitate to send us your application, we can't wait to meet you!

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

Main Responsibilities:

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.

Desired Profile:

• 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 is 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;
• Excellent planning and time management skills;
• Proficiency MS Office.

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!

Other details

  • Pay Type Salary
  • Laval, QC, Canada