QC Reviewer (BSD)

Job description

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 QC reviewer is responsible to perform the quality control for data generated and work conducted in the laboratory. What You'll Do Here 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. What You'll Need to Succeed College degree and/or University degree in Chemistry, Biochemistry or Immunology or equivalent field. Pertinent experience may be considered in lieu. Experience in the medical and/or pharmaceutical fields with typically 3 years of experience in data review and quality control field. Must understand general SOPs and have knowledge of GLP regulations. Proven organizational skills Excellent attention to details with respect to sample preparation procedures and raw data handling. Strong communication and leadership skills. Ability to work cross functionally. Good MS Office skills. Altasciences strives to provide a French working environment for its employees in Quebec. Although as part of its francization program has taken all reasonable steps to avoid imposing the above-mentioned requirement. Fluency in English is an essential requirement for the position of QC reviewer including, but not limited to, for the following reasons: 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 Altasciences' Incentive Programs Include: Training & Development Programs Employee Referral Bonus Program Annual Performance Review 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!