QA Associate

Apply Now

About This Opportunity

Location

Dartmouth, Nova Scotia, Canada

Remote

In person, Remote, or Hybrid

Department

Biotechnology | Pharmaceutical

Experience Level

Experienced

Employment Type

Full-time - Permanent

As part of the Quality Assurance group with IMV and reporting to the Associate Director of Quality Assurance, in this role you will ensure the quality of our processes while supporting our Quality Management System.

Duties & Responsibilities

What you'll do

Work closely with all departments to ensure products and processes conform to internal SOPs, documented procedures, and expected quality levels

Review GMP manufacturing and packaging documentation, such as batch records, label proofs, GMP specifications, and certificates. Prepare release documentation for QA Management approval

Write and review SOPs, change controls, qualification reports, specifications, protocols, whenever required

Conduct vendor qualification activities including initial qualification and ongoing requalification

Contribute to maintaining document management and training for quality controlled documents in the electronic Quality Management System (eQMS)

Maintain paper filing where applicable

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.

Oversee closure of quality events in a timely manner through collaboration with the Owning Departments

Prepare and assess the procedures associated with the initiation and reporting of deviations/incidents, complaints, self- inspections and CAPAs

Provide oversight of the calibration and validation program of equipment and systems with the Owning Departments, maintaining the quality management of equipment

Perform other clerical, laboratory, administrative and miscellaneous duties as required and/or instructed by the Associate Director, Quality Assurance

Qualifications

What you'll need

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
Have strong written and oral communication skills
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 and able to adapt to shifting priorities
Are able to train effectively and have good presentation skills

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

Key Experience, Competencies and Skills

Minimum 3+ years Quality Assurance and Compliance experience in the pharmaceutical industry
Knowledge of FDA/ Health Canada/ EU GMP, ICH guidelines and regulatory requirements
Experience with GMP operations, [AE1] [KB2] possessing good understanding of quality assurance and quality control programs, including the QMS
Knowledgeable with Good Documentation Practices
Computer proficient (MS Office such as Word, Excel, Access, Powerpoint)
Data entry experience

The following would be considered assets;

Knowledge of GCPs
Experience in interacting with Regulatory Agencies in an audit setting and correspondence
Working with an eQMS for document management and training

Core Skills

We're looking for

Detail Oriented

Critical Thinking

Organizational Skills

Communication

A Little About IMV Inc.

IMV Inc. is a clinical-stage pharmaceutical company that has the potential to make history by developing a first-in-class effective T cell-targeted immune therapy for cancer. We have built an unprecedented delivery platform (DPX) that generates targeted immune cells directly into the human body, which produces robust, and sustained capabilities to destroy cancer. DPX is the engine that drives our lead drug candidate, Maveropepimut-S (DPX-Survivac), which has successfully completed multiple Phase 1/1b trials, generating best-in-class results in advanced recurrent ovarian cancer and Diffuse Large B Cell Lymphoma (DLBCL).

Our Platform Enables a Strong, Sustained Immune Response

The unique "no-release" mechanism of action of our DPX Platform allows antigen-presenting cells (APCs) to be attracted to the injection site, facilitating antigen presentation to immune cells. All our immunotherapies and vaccine candidates are formulated with the DPX platform, giving them the ability to generate, in vivo, a targeted, robust, and sustained immune response against cancer cells or viruses.

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.

Applications will be considered upon receipt.

*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. As it turns out, that does make all the difference.

Valuable Work

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.