Quality Assurance Auditor (Remote position in the Montreal area - 18 month Contract)

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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.

You have experience in QA and you want to make a difference by helping to improve people’s quality of life, our opportunity will surely interest you! As a fast-growing contract research organization, you will have the opportunity to develop your skills and advance your career. If you stand out for your flexibility, your organizational skills and your attention to detail; don’t hesitate to send us your application!

We are currently looking to fill the Quality Assurance Auditor position within our Quality Assurance department for the Laboratory Team. To accept this challenge is to accept the responsibility for auditing the documentation and activities that are related to bioanalytical studies as well as emitting QA statements for study release with respect to the general conformity of GLP and GCP regulations.

Main Responsibilities

• Carrying out systematic and independent examination (audit) of multiple trial related activities and documents, to determine whether the evaluated trial related activities were conducted, and the data were recorded, analyzed, and accurately reported according to the protocol, standard operating procedures (SOPs), good laboratory practice (GLP), Good Clinical Practice (GCP) and other applicable regulatory requirements;
• Writing QA audit reports and conveying them to the management team of the audited department (e.g., Team Manager, Study Manager, Director, etc.);
• Perform process, facility, equipment, software and vendor audits as needed;
• Build and maintain good working relationships within the organization;
• Other related tasks.
  

Desired Profile

• DEC or University degree in Chemistry, Biochemistry, Biology or similar field;
• Experience in bioanalysis or quality assurance in the pharmaceutical industry is an asset;
• Knowledge and understanding of the applicable Canadian, US, European, Good Laboratory Practices (GLP)s and (GCPs) for research studies;
• Detail oriented and demonstrate the ability to meet tight deadlines;
• Flexible, adaptable, demonstrate great organization skills and priorities management;
• Bilingualism (French and English);
• Remote position (the office is based in Laval).
  

Working Conditions

• 18 month Contract;
• Day shift - 37.5 hours/week.
  

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!

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