Quality Control Reviewer

Jobinhalt

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 are a QC Reviewer 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 organizational skills and your attention to details; don’t hesitate to send us your application!

The QC reviewer is responsible to perform the quality control for data generated and work conducted in the laboratory.

Main responsibilities:

• Ensures that all batch related documentation is completed accurately and in a timely manner by the analysts and that all procedures are respected as per the company’s SOPs.
• Based on training QC reviewer can draft study documents for BPI review such as Memo to File, SOP/Protocol/Study Plan deviations., perform quality control batch review by performing multi-batch trend analysis,and compile study documentation,
• Based on training, provide report and/or final results within study timelines and ensure any deviation, exception or events are reflected as appropriate and assure that all analysis conducted are reported and accurate for the review of the Bioanalytical Principal Investigator .
• Based on training, responsible for daily in process quality control for batches ongoing in the lab.
• Raises any flags to line manager regarding any quality issue or trends observed and is part of addressing these issues in an appropriate manner.
• Supports responses to QA reports.
• Monitors the quality within the laboratory according to GLP, regulatory agencies requirements and internal SOPs.
• Supports and mentors analysts in the daily laboratory documentation procedures and processes.
• Can participate in basic training of laboratory staff.
• Could be assigned to ensure that the verification of laboratory instruments is performed as required by the internal procedures.
• Could be assigned to ensure harmonization of techniques, process and documentation between analysts in the laboratory.
• May be required to participate in laboratory inspections: executes and reports deviations and any health and safety concerns.
• As assigned, assist for planning sample analysis by maintaining timeline and scheduling commitments.
• Stays up to date on new SOPs, procedures, and techniques via training sessions, team meetings and internal communication avenues and observes all company guidelines and policies.
• Respecting Health and Safety standards in terms of personal protection, laboratory maintenance, and work procedures.

Desired profile:

• College degree and/or University degree in Chemistry, Biochemistry, Immunology or equivalent field. Pertinent experience may be considered in lieu;
• Experience in the medical and/or pharmaceutical fields with approximately 3 years of experience in data review and quality control field. Must understand general SOPs and have knowledge of GLP regulations;
• Good organizational skills;
• Attentive to details with respect to sample preparation procedures and raw data handling;
• Good communication and able to work with different teams;
• Good leadership;
• Bilingualism (French and English);
• Knowledge MS-Office and Outlook.

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!