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.
The QA Associate is responsible for carrying out systematic and independent examination (i.e., 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), GxPs and the applicable regulatory requirements. He/she is responsible for reporting any findings to the Internal Study Team and department management (e.g., Team Manager, Study Manager, Director, etc.). He/she is responsible for building and maintaining effective working relationships throughout the organization.
Under supervision of a mentor/coach, performs the following tasks:
- Audits phases of laboratory and clinical studies, reports, and performs related duties (e.g., issues findings and QA statements) to ensure regulatory compliance;
- Audits all disciplines (examples of disciplines include Screening, Recruiting, Clinical Operations, Laboratory, SRA, Data Services);
- Writes and issues inspection reports. Works with internal clients to ensure that inspection findings are clearly communicated and understood. Evaluates inspection finding responses to ensure they are written to address the findings appropriately;
- Ensures through phase and data inspections that the SOPs, which are involved in the conduct of a study, are current and practiced;
- Introduction to in-life audits, process audits, vendor qualifications, equipment and software validation audits;
- Identifies and communicates opportunities for process improvement based on audit and inspection observations;
- Maintains necessary documentation of QA records and study files;
- Notifies management of observed quality and compliance trends in the areas inspected;
- Interprets GCP, GLP, and GCLP and associated regulatory documents to facilitate auditing and process improvement recommendations.
- Carries out appropriate self-development efforts as directed.
- Performs other related duties as assigned.
- Bachelor degree or higher, in Chemistry, Biochemistry, Biology, or equivalent field, or equivalent combination of education and experience, in the pharmaceutical industry;
- Basic knowledge and understanding of the applicable Canadian, US, European, and ICH pharmaceutical regulations and guidelines, for preclinical and phase I research studies (i.e., GCP, GLP, and GCLP);
- Highly organized; ability to prioritize and demonstrate attention to detail;
- Time management skills are required, as well as the ability to handle multiple projects;
- Ability to meet tight deadlines;
- Tactful, reliable, persuasive, dependable, consistent, flexible;
- Good written and oral communication skills in French and English;
- Software: Microsoft Office. Knowledge of Master Control, Watson LIMS and Analyst an asset.
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!