We are looking for a well-organized and detailed oriented individual to join our team. Reporting to the Quality Assurance Manager as QA Associate you will be ensuring the quality of our processes while supporting our Quality Management System.
What you'll do
- Work closely with all departments to ensure products and processes conform to internal SOPs, documented procedures, and expected quality levels.
- Write and review SOPs, change controls, qualification reports, specifications, protocols, whenever required.
- Contribute to maintaining the filing system for quality documents (both electronic and paper) such as SOPs, equipment, calibration, training
- Write reports and work instructions as required.
- Conduct quality training on Quality Management Systems, processes and provides assistance in annual GMP training.
- Support internal and external audits.
- Assist with responses to external, internal and Regulatory audit observations.
- Provide assistance with the vendor qualification program.
- Prepare and assess the procedures associated with the initiation and reporting of deviations/incidents, complaints, self- inspections and CAPAs.
- Undertake the calibration and validation program of equipment and systems, maintaining the quality management of equipment.
- Perform other clerical, laboratory, administrative and miscellaneous duties as required and/or instructed by the QA Manager.
What you'll need
Education- Degrees, Licenses, Certifications
Completion of a post-secondary diploma or related scientific degree is required (BSc. or higher degree in Chemistry, Biochemistry or Microbiology).
Additional Valuable Education-Degrees, Licenses, Certifications
Pharmaceutical training certification or equivalent certification is an asset
- Minimum 3+ years Quality Assurance and Compliance experience in the pharmaceutical industry.
- Excellent in-depth knowledge of FDA/ Health Canada/ EU GMP, ICH guidelines and regulatory requirements.
- Basic knowledge of GCPs would be an asset.
- Experience with GMP laboratory operations, possessing good understanding of quality assurance and quality control programs, including the QMS.
- Experience in interacting with Regulatory Agencies in an audit setting and correspondence would be an asset.
Computer proficient (MS Office such as Word, Excel, Access, Powerpoint)
To be successful in this role you;
Have excellent attention to detail and high organizational prowess
Are able to work in a fast-paced environment, consistently delivering results on time
Are self-driven and able to work with minimal supervision
Have effective interpersonal and teamwork skills
Have exceptional attention to detail and accuracy to maintain compliance
Are an analytical thinker with the ability to prioritize tasks and problem solve
Excel in a position where you multi-task and work well under pressure
Are able to coach and train effectively
Can be a positive influence at all levels within the organization
Have strong written and oral communication skills
Are flexible and able to adapt to shifting priorities
Possess team leadership skills
We're looking for
A little bit about us
IMV Inc. is a clinical stage biopharmaceutical company dedicated to making immunotherapy more effective, more broadly applicable, and more widely available to people facing cancer and other serious diseases. IMV is pioneering a new class of cancer-targeted immunotherapies and vaccines based on the Company's proprietary drug delivery platform. This patented technology leverages a novel mechanism of action that enables the programming of immune cells in vivo, which are aimed at generating powerful new synthetic therapeutic capabilities. IMV's lead candidate, DPX-Survivac, is a T cell-activating immunotherapy that combines the utility of the platform with a target: survivin. IMV is currently assessing DPX-Survivac as a monotherapy in advanced ovarian cancer, as well as a combination therapy in multiple clinical studies with Merck. IMV is also developing a DPX-based vaccine to fight against COVID-19. Visit www.imv-inc.com and connect with us on Twitter and LinkedIn.
Are you interested?
Work With Us
Please indicate in your application, your salary expectations and your availability for this position.
Compensation will be determined based upon skill set and experience of the selected candidate and benchmarking for the position. IMV offers paid vacation, health/ dental plan, employee assistance program, stock options, and annual bonuses.
If you feel that you are the best candidate for this position, please apply through the "Apply Now" button.
Please clearly indicate in your application how you meet the requirements for this role and why you think you would be the best candidate for the role.
Closing has been extended and applications will be considered until July 8th 2020
*We appreciate your application but only candidates selected for interviews will be contacted. We reserve the right to request interview candidates to complete skill/ behavior based assessments as part of the interview process.
Strong Science Needs Bright Minds
At IMV, we have high standards. And even higher aspirations.
Our drug candidates are helping us build on this promise. Our technology provides the tools that underscore this mission. And our people are the heart of our operation-the ultimate value-drivers upon which we, as a Company, rest.
We Work Better Together
Curing diseases-especially the ones that continue to evade and outpace even the brightest minds in our industry-is hard work. Despite the intensity and ferocity of our business, the one thing we do not have to worry about is the morale and the spirit of our people. We work hard and we play hard. Our people enjoy our drive, our mission and the road less traveled here in Halifax. As it turns out, that does make all the difference.
We aim high with our mission, so we expect high performance from our people. Whether you are evaluating T cell responses, coordinating clinical operations with our partners, or working with our investor base, we depend on you to help realize the full value of our organization. In turn, we value you, and what you can bring to our Company. We support you in enjoying life fully while working towards your professional goals. Above all, we cultivate the camaraderie that is the hallmark of our corporate culture.
Happy Employees Produce Strong Results.