Quality Assurance Specialist, Document Management

3 weeks ago

Vancouver, Canada STEMCELL Technologies Full time

**Job Description Summary**:
STEMCELL Technologies is seeking a highly skilled and detail oriented Quality Assurance Specialist with expertise in document management and training to join our Quality Assurance team. If you have strong attention to detail, excellent time management skills and previous experience with electronic quality management systems then this role is for you.

As a Quality Assurance Specialist, Document Management and Training your responsibilities will include managing the training program, collaborating with department training coordinators, assigning individuals to appropriate training, delivering training, and addressing inquiries related to the training program. Additionally, you will be processing documents through the electronic document management system, reviewing documentation, such as batch records, and assisting with record management. You will have the opportunity to work closely with cross-functional teams to ensure compliance with regulations and standards. Your ability to effectively manage the training program and oversee document management will be crucial to maintaining the integrity of our operations.

**Duties and Responsibilities**
- Review, verification, processing of QMS documents, records, and training courses to ensure compliance to Quality Management Standards such as ISO 9001/13485/relevant GMPs and established procedures
- Manage the training program, working closely with training coordinators to maintain department’s training matrix, develop and implement effective training strategies, including assigning individuals to the appropriate training based on their roles in the company
- Support the team through development & delivery of formal training material/activities and maintenance of existing training materials
- Identify compliance and process issues, gaps to managers Proactively collaborate with stakeholders to identify any investigations and solutions
- Write, review, and revise internal procedures, ensuring accuracy, completeness, and compliance with regulatory requirements

**Knowledge and Qualifications**
- Bachelor's degree with 2-6 years of relevant experience in quality and/or regulatory in the biotech or equivalent industry
- Working knowledge / experience of regulatory requirements (e.g. ISO 13485, ISO 9001, cGMP) and electronic quality management systems (eQMS)
- Excellent prioritization and time management skills with the ability to manage and coordinate completion of tasks on a priority basis.
- Self motivated individual with the ability to work independently and as part of a team with experience working cross departmentally.
- Excellent communication skills with effective planning and organizational skills and experience in project implementation

**United #LI-Hybrid**

STEMCELL Technologies Inc. is a privately-owned biotechnology company based in Vancouver that helps power leading-edge life science research around the world. Scientists performing stem cell, immunology, cancer, regenerative medicine and cellular therapy research are among those who rely on our cell culture media, cell separation products, instruments, ancillary reagents and contract assay services. We create novel, useful, standardized products of unfailing quality and deliver them to more than 70 countries via our many regional offices plus distribution centres in Vancouver, Seattle, Grenoble and Singapore. Driven by our love of science and our passion for quality, we see ourselves simply as “Scientists Helping Scientists” - standing by our customers to provide outstanding products, technical support and training. We have over 1000 science-oriented employees globally, including 250 PhDs/MScs, with most others holding a BSc or engineering degree. STEMCELL is proud to be the largest Biotechnology employer in Canada.

This is an opportunity to work with highly motivated colleagues in a science-oriented, creative, and dynamic environment. We offer a competitive salary, excellent benefits, and meaningful career development opportunities.

STEMCELL is well recognized for exceptional leadership and business practices. We are one of Canada’s Best Managed Companies and operate an ISO 14001-certified environmental management system to measure and reduce our environmental impact.

As an equal opportunity employer, STEMCELL is dedicated to ensuring that every employee feels safe, valued, and respected for who they are. We know that scientific progress and innovation occur when diverse, creative minds come together and we are committed to nurturing a culture of inclusivity and belonging. STEMCELL enforces a zero-tolerance policy for any form of discrimination. Selection decisions are solely based on job-related factors.

To apply, please select the “Apply” button below. You will then be directed to a login screen asking you to set up an account, which is required to apply.

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