QC Reviewer, LBA

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 Le/la Réviseur(se) contrôle qualité, LBA est chargé(e) d'effectuer les contrôles de qualité des données générées et des travaux réalisés au sein du laboratoire afin de garantir leur exactitude, leur conformité et le respect des normes applicables. What You’ll Do Here Ensure that all batch-related documentation is completed accurately and on time by the analysts, and that all procedures are followed in accordance with the company’s standard operating procedures (SOPs) Conduct daily in-process quality control for batches currently being processed in the laboratory Provide support in responding to quality assurance reports Monitor quality within the laboratory in accordance with Good Laboratory Practice (GLP), regulatory requirements, and internal Standard Operating Procedures (SOPs) Guide and supervise analysts in the laboratory’s daily documentation procedures and processes Ensure that laboratory instrument calibration is performed in accordance with internal procedures. Ensure consistency in techniques, processes, and documentation among laboratory analysts. Report quality issues or trends to the line manager and participate in resolving them. May be required to participate in laboratory inspections: identify and report nonconformities as well as any health and safety issues. Based on their training, be able to draft study documents for review by the bioanalytical manager (BPI), such as notes for inclusion in the file, reports on deviations from standard operating procedures (SOPs), the protocol, or the study plan; perform quality control on batches by conducting trend analyses across multiple batches; and compile study documentation Depending on their training, be able to provide reports and/or final results within the study’s specified deadlines, ensure that any deviations, exceptions, or events are properly documented, and ensure that all analyses performed are recorded and accurate for review by the principal investigator in bioanalysis Contribute to the planning of sample analysis by meeting deadlines and honoring scheduling commitments. Stay informed about standard operating procedures (SOPs), procedures, and techniques through training sessions, team meetings, and internal communication channels, and comply with all company guidelines and policies Comply with health and safety standards regarding personal protective equipment, laboratory maintenance, and work procedures What You’ll Need to Succeed College degree in Chemistry, Biochemistry or Immunology or equivalent field. Minimum of 2 years of experience in the medical and/or pharmaceutical fields MS Word, Excel, Outlook and Power Point Ability to read and interpret technical documents and industry specific manuals. Ability to write advanced reports and correspondence. Ability to speak effectively before groups of employees of the organization. Bilingual proficiency in French may be required, depending on location. Excellent verbal and written communication skills. Well developed interpersonal skills are required. Personal/professional integrity and proven discretion in handling confidential information. Ability to develop strong trusting relationships in order to gain support and achieve results. Capable of managing multiple conflicting priorities. Must be self-directed, motivated, and have a willingness to take the initiative to identify and anticipate client needs and make recommendations for implementation. 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 QC Reviewer, LBA in particular, but without limitation, for the following reason(s): The requirement to have study protocols read 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 #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!