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 Senior QA Auditor is responsible for implementing systematic and independent examination (I.e., inspection or audit) of study-related activities and documents; to determine whether the evaluated study-related activities were conducted in a compliant manner; and to assure that the data were recorded, analyzed, and accurately reported according to the applicable regulatory requirements, protocol, method, and SOPs. Responsible for building and maintaining effective working relationships with the study directors, contributing scientists/principal investigators, and responsible scientists. What You'll Do Here Supports sponsor inspections. Supports internal facility audits. Identifies compliance gaps in processes, systems, and studies; collaborates with QA management to enact change. May support trainer(s) for compliance sessions for the department. Recognizes and supports opportunities for improvements within the department. Acts as lead auditor on studies/projects; facilitates planning and implementation. Performs audits of protocols/plans and audits of supporting documentation, data, and reports. Performs phase inspections of on-going study/project activities. Prepares, issues, and tracks reports of findings and recommendations noted during inspections and audits; assures findings and recommendations accurately reflect requirements of the regulations, protocol/plan, method, or SOP(s). Maintains audit files to support auditor activities. Audits equipment qualification and software validations. What You'll Need to Succeed Bachelor degree or higher in a scientific discipline, or equivalent combination of education and experience. Two to three years related technical experience and/or training. A minimum of two years auditing in a GLP-regulated environment. Professional certification such as RQAP-GLP (Registered Quality Assurance Professional-GLP) or ASQ-CQA (American Society of Quality– Certified Quality Auditor) or other certification is recommended. Microsoft Office Suite efficiency Technical scientific writing skills. Ability to read and interpret documents such as procedures, study records, equipment & software manuals, and safety rules; Ability to write clear correspondence and routine reports; ability to speak effectively to employees within the organization and sponsors. Ability to utilize appropriate mathematical concepts to independently verify study results. Ability to work with minimal supervision; ability to audit most disciplines. Ability to interpret a variety of instructions provided in written, oral, diagram, or schedule format; ability to demonstrate attention to detail. Training needs for this position include on-the-job training in performing audits and inspections, and independent reading of professional articles, journals and internal SOPs. Attendance at training seminars, regional and national meetings in Quality Assurance, regulatory affairs and validation, along with continual GLP training. 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 the Senior QA, Auditor in particular, but without limitation, for the following reason(s): The requirement to have study protocols, designs and clinical research documents written 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 Telework when applicable Altasciences’ Incentive Programs Include: Training & Development Programs Employee Referral Bonus Program Annual Performance Reviews #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!
