About this role
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 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 #LI-MB1 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!